Dental Anxiety
Conditions
Keywords
dental avoidance, dental phobia, pain sensitivity
Brief summary
The overall objective of the activities described in this protocol is to examine the efficacy of the Internet-based intervention in the reduction of dental anxiety in patients seeking dental treatment. This study has 2 primary objectives and 2 secondary objectives: Primary Objective 1-Therapy Aides: To compare the efficacy of the intervention as administered by personnel with training and experience in cognitive behavioral therapy (CBT) to the efficacy of the intervention as administered by dental staff who have undergone a brief but specific training in the administration of the intervention. Primary Objective 2-Intervention Efficacy: To compare the efficacy of the intervention, administered by either type of therapy aide (CBT personnel or dental staff), to an active control condition. Secondary Objective 1-Tests of Moderators: To examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the dental anxiety intervention, regardless of therapy aide, in comparison to an active control condition. Secondary Objective 2-Other Intervention Effects: To explore effects of the intervention beyond primary efficacy, including attendance at recall visits in the 12 months after the intervention; pain intensity; avoidance due to fear of dental procedures; and client satisfaction.
Detailed description
This clinical trial will evaluate the efficacy of a brief Internet-based cognitive-behavioral intervention for the treatment of impairing dental anxiety among those seeking dental care at the clinics of a university dental school. The primary objective of human subjects activities described in this protocol is to evaluate the efficacy of the Internet-based intervention for dental anxiety among patients presenting to the participating clinic(s). To achieve this overall objective, 2 primary objectives and 2 secondary objectives have been proposed: Primary Objective 1-Therapy Aides: To compare the efficacy of the intervention as administered by personnel with training and experience in cognitive behavioral therapy (CBT) to the efficacy of the intervention as administered by dental staff who have undergone a brief but specific training in the administration of the intervention. Efficacy will be indexed by measures of dental anxiety and fear completed at 1-month and 3-month follow-up assessments. Primary Objective 2-Intervention Efficacy: To compare the efficacy of the intervention, administered by either type of therapy aide (CBT personnel or dental staff), to an active control condition. Efficacy will be indexed by measures of dental anxiety and fear completed at 1-month and 3-month follow-up assessments. Secondary Objective 1-Tests of Moderators: To examine whether baseline levels of distress tolerance and pain sensitivity moderate the efficacy of the dental anxiety intervention, regardless of therapy aide, in comparison to an active control condition. Secondary Objective 2-Other Intervention Effects: To explore effects of the intervention beyond primary efficacy, including attendance at recall visits in the 12 months after the intervention; pain intensity; avoidance due to fear of dental procedures; and client satisfaction. Patients (N=450) between the ages of 18 and 75 attending the Temple University Kornberg School of Dentistry (TUKSoD) dental clinics and reporting high dental anxiety that causes at least mild impairment will be recruited and consented. To obtain the sample, the investigators will screen all patients who present to the Faculty Practice Clinic (FPC) of TUKSoD (as well as the Graduate Clinics of TUKSoD \[Endodontology, Periodontology, Advanced Education General Dentistry\], if necessary). Total participation time for each patient is approximately 4 months but could be slightly longer pending the interval between screening/baseline and the scheduled date of the dental anxiety intervention/dental appointment.
Interventions
BEHAVIORALInternet-based intervention for dental anxiety
Participants will complete the experimental dental anxiety management program, which will be facilitated by a person trained in psychological treatments or by dental staff. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Given the obvious differences between those who will receive the Internet-based dental anxiety and those who will not (i.e., those who are assigned to the control condition), we will not be able to blind patients to this aspect of randomization. Patients will not be informed about the professional affiliation of therapy aides, who will dress similarly (e.g., professional dress and a lab coat) and who will be instructed not to respond to questions related to this topic.
Intervention model description
This will be a single-center parallel groups study with randomization to one of three arms: (1) a treatment condition (Tr1) in which the dental anxiety intervention is administered by CBT personnel (n=150), (2) a treatment condition in which the dental anxiety intervention is administered by dental staff (Tr2) (n=150), or (3) an active control (AC) group (notification of the dental providers of the patient's score on a dental anxiety scale before their dental treatment appointment). In addition, control participants will be asked to view a video of nature scenes for a period of time equivalent to the dental anxiety intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patient endorses high dental anxiety (a score of 19 or a score of 4-5 on at least 2 of the 5 items) on the MDAS * endorses at least mild impairment as a result of that anxiety at the baseline interview as indexed by the appropriate rating in the specific phobia module of the ADIS-5 * be between 18 and 75 years of age * be sufficiently fluent in written and spoken English in the judgment of project staff that the patient would be able to benefit from the intervention and validly complete the assessments.
Exclusion criteria
* a self-reported current medical condition (e.g., cardiopulmonary disease, seizure disorder) that might make exposure to anxiety-evoking stimuli inadvisable * current suicidal/homicidal ideation/intent or other condition that would take priority over an intervention focused on dental anxiety * current psychosis, mental retardation, or other condition that would significantly diminish the patient's ability to adequately focus attention adaptively on the current protocol * inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | The MDAS will be administered at the baseline assessment and at one- and three-month follow-ups. | The MDAS is a widely used 5-item measure assessing fear of dental procedures, including cleaning, drilling, and local anesthetic injections; for example, If you were about to have your tooth drilled, how would you feel? Items are rated on a 5-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). The total score ranges from 5 to 25; a score of 19 or above indicates high anxiety based on receiver operating characteristic analyses from previous studies. |
| Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) | The ADIS-5 will be administered at the baseline assessment and at one- and three-month follow-ups. | The ADIS-5 is a semi-structured interview designed to establish reliable diagnoses of the DSM-5 anxiety, mood, somatoform, and substance use disorders. To minimize participant burden, this study will utilize only the dental procedure-related section of the specific phobia module of the interview. This module includes ratings of fear and avoidance of dental procedures (0 = No fear/Never avoids to 8 = Very severe fear always avoids) as well as resultant interference (0 = None to 8 = Very severe; the latter being used to operationalize one of the inclusion criteria). For the dental phobia diagnosis, a dimensional clinical severity rating (CSR), ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. All interviews will be audio-recorded. The 0-8 rating of dental fear will serve as the primary measure derived from the ADIS-5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Sensitivity Index (PSI; Gross, 1992a). | It will be administered at baseline and the 1-month and 3-month follow-ups. | The PSI is a 16-item self-report measure that assesses the fearful appraisal of pain and the expected physical, psychological, and social consequences of pain. Items are rated on a scale ranging from 0 (not at all) to 7 (very much) reflecting the degree to which the item applies to the respondent. Higher scores indicate higher levels of pain sensitivity. The minimum PSI score is 0, while the maximum PSI score is 112. |
| Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | The DTS will be administered at the baseline assessment and at one- and three-month follow-ups | The DTS is a 15-item self-report measure assessing one's perceived ability to experience and tolerate negative emotional states. This scale measures four dimensions of distress tolerance: subjective appraisal of distress, ability to tolerate emotional distress, absorption of attention by negative emotions, and regulation efforts to alleviate distress. Items are rated on a scale ranging from 1 (strongly agree) to 5 (strongly disagree). Total score range from 15 to 75, with higher scores reflecting higher levels of distress tolerance. |
| Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | It will be administered at the baseline assessment and at one- and three-month follow-ups. | The FQ-BII is a 5-item subscale of the complete FQ. It assesses the degree to which an individual avoids situations involving blood-injury-injection because of fear, including in the context of dental procedures. Items are rated on a scale ranging from 0 (would not avoid it) to 8 (would always avoid it). Total scores range from 0-40 with higher scores indicating greater phobic avoidance. |
| Change in Avoidance Rating From the ADIS-5 | baseline assessment, and at one- and three-month follow-ups. | The rating of avoidance included in the specific phobia module of the ADIS-5 will be considered a secondary outcome measure. For the dental phobia diagnosis, a dimensional clinical severity rating, ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. |
| Change in Distress and Interference Rating From the ADIS-5 | baseline assessment, and at one- and three-month follow-ups. | The rating of distress and interference included in the specific phobia module of the ADIS-5 will be considered a secondary outcome measure. For the dental phobia diagnosis, a dimensional clinical severity rating, ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. |
| Change in Percentage of Dentally Phobic Patients From the ADIS-5 | baseline assessment, and at one- and three-month follow-ups. | Percentage of patients who meet criteria for a specific phobia of dental procedures at baseline. We will examine whether this percentage decreases as a function of the arm of the study to which patients are assigned. |
| Change in Attendance at Dental Appointments | 1 year post-dental anxiety intervention | We will utilize TUKSoD's automated scheduling system (axiUm, http://www.axiumdental.com/) to collect information about dental attendance. |
| Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). | The CSQ-8 will be administered post-intervention (within 48 hours after the participant's dental appointment), as well as at the one- and three-month follow-ups. | The CSQ-8 is used in the measurement of client/patient assessment of satisfaction with services and clinical care. It consists of 8 items rated on a 1-to-4 scale. Higher scores indicate greater satisfaction with services, with a minimum score of 8 and a maximum score of 32. |
| Pain Intensity Numeric Rating Scale (PI-NRS). | These ratings will be administered as part of the post-appointment debriefing interview, as well as at the 1-month and 3-month follow-ups. | The PI-NRS is a widely utilized 11-point self-report measure that assesses physical pain intensity on a scale ranging from 0 (no pain) to 10 (worst possible pain). Anxiety increases subjective pain experience, and therefore this scale will be used to assess the intensity of dental-related pain that participants expect to experience at their dental appointment scheduled after the dental anxiety intervention (or control), the intensity of pain they actually experienced, and the intensity of pain they expect to experience at their next similar dental appointment. |
Countries
United States
Participant flow
Recruitment details
To be eligible, patients had to be between 18 and 75 years of age, fluent in spoken and written English, have scheduled a dental treatment appointment, be willing and able to give informed consent, participate responsibly in the study protocol, meet criteria for high dental anxiety based on the MDAS, and endorse at least some oral-health related impairment at the administration of a semi-structured diagnostic interview. Recruitment was carried out at Temple University School of Dentistry clinics
Pre-assignment details
Participants were randomly assigned to one of three arms after their baseline visit was completed. Please see more information about individual arms below.
Participants by arm
| Arm | Count |
|---|---|
| Psychology Intervention Intervention was administered by psychology personnel with graduate-level training and experience in CBT (e.g., psychologists, postdoctoral fellows) | 162 |
| Dental Intervention Intervention was administered by dental staff with brief but specific training in the administration of the CBT intervention (e.g., dental assistants). | 167 |
| Control These participants were assigned to a time- and attention matched control condition, which consisted of watching an hour long nature video. | 170 |
| Total | 499 |
Baseline characteristics
| Characteristic | Psychology Intervention | Dental Intervention | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 49.7 Years STANDARD_DEVIATION 15.5 | 49.3 Years STANDARD_DEVIATION 14.3 | 48 Years STANDARD_DEVIATION 14.8 | 49 Years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 15 Participants | 20 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 135 Participants | 150 Participants | 149 Participants | 434 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 2 Participants | 1 Participants | 9 Participants |
| Modified Dental Anxiety Scale | 19.4 Score on a Scale STANDARD_DEVIATION 3.8 | 19.4 Score on a Scale STANDARD_DEVIATION 3.9 | 19.8 Score on a Scale STANDARD_DEVIATION 3.1 | 19.5 Score on a Scale STANDARD_DEVIATION 3.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 8 Participants | 6 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 92 Participants | 99 Participants | 110 Participants | 301 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 10 Participants | 5 Participants | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 6 Participants | 5 Participants | 17 Participants |
| Race (NIH/OMB) White | 47 Participants | 43 Participants | 39 Participants | 129 Participants |
| Region of Enrollment United States | 162 Participants | 167 Participants | 170 Participants | 499 Participants |
| Sex/Gender, Customized Female | 115 Participants | 109 Participants | 125 Participants | 349 Participants |
| Sex/Gender, Customized Male | 43 Participants | 53 Participants | 44 Participants | 140 Participants |
| Sex/Gender, Customized Others | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Sex/Gender, Customized Unknown/Missing | 3 Participants | 2 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 162 | 0 / 167 | 0 / 170 |
| other Total, other adverse events | 0 / 162 | 1 / 167 | 0 / 170 |
| serious Total, serious adverse events | 0 / 162 | 0 / 167 | 0 / 170 |
Outcome results
Primary
Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995).
The MDAS is a widely used 5-item measure assessing fear of dental procedures, including cleaning, drilling, and local anesthetic injections; for example, If you were about to have your tooth drilled, how would you feel? Items are rated on a 5-point Likert-type scale ranging from 1 (not anxious) to 5 (extremely anxious). The total score ranges from 5 to 25; a score of 19 or above indicates high anxiety based on receiver operating characteristic analyses from previous studies.
Time frame: The MDAS will be administered at the baseline assessment and at one- and three-month follow-ups.
Population: Overall number of participants analyzed reflects baseline enrollment numbers. 1 Month and 3 Month MDAS reports a smaller n due to participant dropout throughout the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychology Intervention | Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | 1 Month | 16.7 score on a scale | Standard Deviation 4.7 |
| Psychology Intervention | Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | Baseline | 19.8 score on a scale | Standard Deviation 3.1 |
| Psychology Intervention | Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | 3 Month | 15.5 score on a scale | Standard Deviation 4.9 |
| Dental Intervention | Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | 1 Month | 17.2 score on a scale | Standard Deviation 4.6 |
| Dental Intervention | Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | Baseline | 19.4 score on a scale | Standard Deviation 3.9 |
| Dental Intervention | Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | 3 Month | 16.1 score on a scale | Standard Deviation 4.8 |
| Control | Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | Baseline | 19.4 score on a scale | Standard Deviation 3.8 |
| Control | Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | 3 Month | 17 score on a scale | Standard Deviation 4.6 |
| Control | Change in Modified Dental Anxiety Scale (MDAS; Humphris et al., 1995). | 1 Month | 18 score on a scale | Standard Deviation 4.4 |
Primary
Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014)
The ADIS-5 is a semi-structured interview designed to establish reliable diagnoses of the DSM-5 anxiety, mood, somatoform, and substance use disorders. To minimize participant burden, this study will utilize only the dental procedure-related section of the specific phobia module of the interview. This module includes ratings of fear and avoidance of dental procedures (0 = No fear/Never avoids to 8 = Very severe fear always avoids) as well as resultant interference (0 = None to 8 = Very severe; the latter being used to operationalize one of the inclusion criteria). For the dental phobia diagnosis, a dimensional clinical severity rating (CSR), ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance. All interviews will be audio-recorded. The 0-8 rating of dental fear will serve as the primary measure derived from the ADIS-5.
Time frame: The ADIS-5 will be administered at the baseline assessment and at one- and three-month follow-ups.
Population: Note: participants who did not meet a minimum threshold of fear during the first six questions of the ADIS were not prompted to continue with the rest of the ADIS interview, including the rating of their dental fear. Participants were required to report a fear score of 4 or above on a 0-8 scale for at least one of the first six questions, which asked participants to rate how much they feared a certain common dental situation (blood from a minor cut, receiving an injection, etc.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychology Intervention | Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) | 1 Month | 4.8 score on a scale | Standard Deviation 2.1 |
| Psychology Intervention | Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) | Baseline | 5.2 score on a scale | Standard Deviation 2 |
| Psychology Intervention | Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) | 3 Month | 4.6 score on a scale | Standard Deviation 1.9 |
| Dental Intervention | Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) | 1 Month | 4.7 score on a scale | Standard Deviation 2.2 |
| Dental Intervention | Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) | Baseline | 5.4 score on a scale | Standard Deviation 2.2 |
| Dental Intervention | Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) | 3 Month | 4.4 score on a scale | Standard Deviation 2.3 |
| Control | Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) | Baseline | 5.4 score on a scale | Standard Deviation 2 |
| Control | Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) | 3 Month | 4.5 score on a scale | Standard Deviation 2.2 |
| Control | Change in Rating of Dental Fear From Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual -5 (DSM-5) - Adult Version (ADIS-5- Brown & Barlow, 2014) | 1 Month | 4.8 score on a scale | Standard Deviation 2.3 |
Secondary
Change in Attendance at Dental Appointments
We will utilize TUKSoD's automated scheduling system (axiUm, http://www.axiumdental.com/) to collect information about dental attendance.
Time frame: 1 year post-dental anxiety intervention
Population: Pre-Intervention = the period of 12 months preceding the participant's intervention or control visit Post-Intervention = the period of 12 months following the participant's intervention or control visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychology Intervention | Change in Attendance at Dental Appointments | Appointments No Showed (Pre-Intervention) | 0.6 Number of Appointments | Standard Deviation 1 |
| Psychology Intervention | Change in Attendance at Dental Appointments | Appointments Completed (Pre-Intervention) | 6.2 Number of Appointments | Standard Deviation 5.3 |
| Psychology Intervention | Change in Attendance at Dental Appointments | Pre-Completion Rate (Pre-Intervention) | 0.8 Number of Appointments | Standard Deviation 0.2 |
| Psychology Intervention | Change in Attendance at Dental Appointments | Appointments Cancelled (Pre-Intervention) | 1.3 Number of Appointments | Standard Deviation 1.9 |
| Psychology Intervention | Change in Attendance at Dental Appointments | Appointments No Showed (Post-Intervention) | 0.8 Number of Appointments | Standard Deviation 1.2 |
| Psychology Intervention | Change in Attendance at Dental Appointments | Appointments Completed (Post-Intervention) | 5.4 Number of Appointments | Standard Deviation 5.8 |
| Psychology Intervention | Change in Attendance at Dental Appointments | Post-Completion Rate (Post-Intervention) | 0.6 Number of Appointments | Standard Deviation 0.3 |
| Psychology Intervention | Change in Attendance at Dental Appointments | Appointments Cancelled (Post-Intervention) | 1.7 Number of Appointments | Standard Deviation 1.9 |
| Dental Intervention | Change in Attendance at Dental Appointments | Pre-Completion Rate (Pre-Intervention) | 0.8 Number of Appointments | Standard Deviation 0.2 |
| Dental Intervention | Change in Attendance at Dental Appointments | Post-Completion Rate (Post-Intervention) | 0.6 Number of Appointments | Standard Deviation 0.3 |
| Dental Intervention | Change in Attendance at Dental Appointments | Appointments Cancelled (Pre-Intervention) | 1.3 Number of Appointments | Standard Deviation 1.9 |
| Dental Intervention | Change in Attendance at Dental Appointments | Appointments No Showed (Post-Intervention) | 0.6 Number of Appointments | Standard Deviation 1.1 |
| Dental Intervention | Change in Attendance at Dental Appointments | Appointments Completed (Post-Intervention) | 5.2 Number of Appointments | Standard Deviation 5.3 |
| Dental Intervention | Change in Attendance at Dental Appointments | Appointments No Showed (Pre-Intervention) | 0.6 Number of Appointments | Standard Deviation 1 |
| Dental Intervention | Change in Attendance at Dental Appointments | Appointments Completed (Pre-Intervention) | 5.7 Number of Appointments | Standard Deviation 4.6 |
| Dental Intervention | Change in Attendance at Dental Appointments | Appointments Cancelled (Post-Intervention) | 1.6 Number of Appointments | Standard Deviation 1.9 |
| Control | Change in Attendance at Dental Appointments | Pre-Completion Rate (Pre-Intervention) | 0.8 Number of Appointments | Standard Deviation 0.2 |
| Control | Change in Attendance at Dental Appointments | Appointments Completed (Pre-Intervention) | 6.2 Number of Appointments | Standard Deviation 5 |
| Control | Change in Attendance at Dental Appointments | Appointments No Showed (Pre-Intervention) | 0.7 Number of Appointments | Standard Deviation 1.1 |
| Control | Change in Attendance at Dental Appointments | Appointments Cancelled (Pre-Intervention) | 1.2 Number of Appointments | Standard Deviation 1.5 |
| Control | Change in Attendance at Dental Appointments | Post-Completion Rate (Post-Intervention) | 0.6 Number of Appointments | Standard Deviation 0.3 |
| Control | Change in Attendance at Dental Appointments | Appointments Completed (Post-Intervention) | 4.6 Number of Appointments | Standard Deviation 4.6 |
| Control | Change in Attendance at Dental Appointments | Appointments No Showed (Post-Intervention) | 0.9 Number of Appointments | Standard Deviation 1.3 |
| Control | Change in Attendance at Dental Appointments | Appointments Cancelled (Post-Intervention) | 1.5 Number of Appointments | Standard Deviation 1.6 |
Secondary
Change in Avoidance Rating From the ADIS-5
The rating of avoidance included in the specific phobia module of the ADIS-5 will be considered a secondary outcome measure. For the dental phobia diagnosis, a dimensional clinical severity rating, ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance.
Time frame: baseline assessment, and at one- and three-month follow-ups.
Population: Note: participants who did not meet a minimum threshold of fear during the first six questions of the ADIS were not prompted to continue with the rest of the ADIS interview, including the rating of their dental fear. Participants were required to report a fear score of 4 or above on a 0-8 scale for at least one of the first six questions, which asked participants to rate how much they feared a certain common dental situation (blood from a minor cut, receiving an injection, etc.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychology Intervention | Change in Avoidance Rating From the ADIS-5 | 1 Month | 3.9 score on a scale | Standard Deviation 2.3 |
| Psychology Intervention | Change in Avoidance Rating From the ADIS-5 | Baseline | 4.7 score on a scale | Standard Deviation 2.3 |
| Psychology Intervention | Change in Avoidance Rating From the ADIS-5 | 3 Months | 3.7 score on a scale | Standard Deviation 2.5 |
| Dental Intervention | Change in Avoidance Rating From the ADIS-5 | 1 Month | 3.9 score on a scale | Standard Deviation 2.5 |
| Dental Intervention | Change in Avoidance Rating From the ADIS-5 | Baseline | 4.7 score on a scale | Standard Deviation 2.4 |
| Dental Intervention | Change in Avoidance Rating From the ADIS-5 | 3 Months | 3.7 score on a scale | Standard Deviation 2.5 |
| Control | Change in Avoidance Rating From the ADIS-5 | Baseline | 4.7 score on a scale | Standard Deviation 2.4 |
| Control | Change in Avoidance Rating From the ADIS-5 | 3 Months | 3.5 score on a scale | Standard Deviation 2.4 |
| Control | Change in Avoidance Rating From the ADIS-5 | 1 Month | 3.8 score on a scale | Standard Deviation 2.5 |
Secondary
Change in Distress and Interference Rating From the ADIS-5
The rating of distress and interference included in the specific phobia module of the ADIS-5 will be considered a secondary outcome measure. For the dental phobia diagnosis, a dimensional clinical severity rating, ranging from 0 = none to 8 = very severely disturbing/disabling, will be assigned, with scores of 4 or above denoting clinical significance.
Time frame: baseline assessment, and at one- and three-month follow-ups.
Population: Note: participants who did not meet a minimum threshold of fear during the first six questions of the ADIS were not prompted to continue with the rest of the ADIS interview, including the rating of their dental fear. Participants were required to report a fear score of 4 or above on a 0-8 scale for at least one of the first six questions, which asked participants to rate how much they feared a certain common dental situation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychology Intervention | Change in Distress and Interference Rating From the ADIS-5 | 1 Month | 4.0 score on a scale | Standard Deviation 1.6 |
| Psychology Intervention | Change in Distress and Interference Rating From the ADIS-5 | Baseline | 4.6 score on a scale | Standard Deviation 1.6 |
| Psychology Intervention | Change in Distress and Interference Rating From the ADIS-5 | 3 Month | 3.9 score on a scale | Standard Deviation 1.6 |
| Dental Intervention | Change in Distress and Interference Rating From the ADIS-5 | 1 Month | 3.9 score on a scale | Standard Deviation 1.6 |
| Dental Intervention | Change in Distress and Interference Rating From the ADIS-5 | Baseline | 4.5 score on a scale | Standard Deviation 1.7 |
| Dental Intervention | Change in Distress and Interference Rating From the ADIS-5 | 3 Month | 3.6 score on a scale | Standard Deviation 1.8 |
| Control | Change in Distress and Interference Rating From the ADIS-5 | Baseline | 4.3 score on a scale | Standard Deviation 1.7 |
| Control | Change in Distress and Interference Rating From the ADIS-5 | 3 Month | 3.4 score on a scale | Standard Deviation 1.5 |
| Control | Change in Distress and Interference Rating From the ADIS-5 | 1 Month | 3.7 score on a scale | Standard Deviation 1.6 |
Secondary
Change in Percentage of Dentally Phobic Patients From the ADIS-5
Percentage of patients who meet criteria for a specific phobia of dental procedures at baseline. We will examine whether this percentage decreases as a function of the arm of the study to which patients are assigned.
Time frame: baseline assessment, and at one- and three-month follow-ups.
Population: Note: participants who did not meet a minimum threshold of fear during the first six questions of the ADIS were not prompted to continue with the rest of the ADIS interview, including the rating of their dental fear. Participants were required to report a fear score of 4 or above on a 0-8 scale for at least one of the first six questions, which asked participants to rate how much they feared a certain common dental situation (blood from a minor cut, receiving an injection, etc.)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Psychology Intervention | Change in Percentage of Dentally Phobic Patients From the ADIS-5 | 1 Month | 72 Participants |
| Psychology Intervention | Change in Percentage of Dentally Phobic Patients From the ADIS-5 | Baseline | 131 Participants |
| Psychology Intervention | Change in Percentage of Dentally Phobic Patients From the ADIS-5 | 3 Month | 61 Participants |
| Dental Intervention | Change in Percentage of Dentally Phobic Patients From the ADIS-5 | 1 Month | 73 Participants |
| Dental Intervention | Change in Percentage of Dentally Phobic Patients From the ADIS-5 | Baseline | 130 Participants |
| Dental Intervention | Change in Percentage of Dentally Phobic Patients From the ADIS-5 | 3 Month | 57 Participants |
| Control | Change in Percentage of Dentally Phobic Patients From the ADIS-5 | Baseline | 140 Participants |
| Control | Change in Percentage of Dentally Phobic Patients From the ADIS-5 | 3 Month | 72 Participants |
| Control | Change in Percentage of Dentally Phobic Patients From the ADIS-5 | 1 Month | 84 Participants |
Secondary
Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979).
The CSQ-8 is used in the measurement of client/patient assessment of satisfaction with services and clinical care. It consists of 8 items rated on a 1-to-4 scale. Higher scores indicate greater satisfaction with services, with a minimum score of 8 and a maximum score of 32.
Time frame: The CSQ-8 will be administered post-intervention (within 48 hours after the participant's dental appointment), as well as at the one- and three-month follow-ups.
Population: Differences in number of participants analyzed at each time point is due to participant drop-out throughout the study. Additionally, participants in the control condition were not administered the CSQ since the questions were not relevant to the time-and attention-matched nature video they were assigned.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychology Intervention | Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). | Post-Intervention | 27.3 score on a scale | Standard Deviation 3.7 |
| Psychology Intervention | Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). | 1-Month | 25.9 score on a scale | Standard Deviation 4.2 |
| Psychology Intervention | Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). | 3-Months | 26.4 score on a scale | Standard Deviation 4.8 |
| Dental Intervention | Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). | Post-Intervention | 27.7 score on a scale | Standard Deviation 3.7 |
| Dental Intervention | Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). | 1-Month | 26.8 score on a scale | Standard Deviation 4.3 |
| Dental Intervention | Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979). | 3-Months | 27.4 score on a scale | Standard Deviation 4.3 |
Secondary
Distress Tolerance Scale (DTS; Simons & Gaher, 2005).
The DTS is a 15-item self-report measure assessing one's perceived ability to experience and tolerate negative emotional states. This scale measures four dimensions of distress tolerance: subjective appraisal of distress, ability to tolerate emotional distress, absorption of attention by negative emotions, and regulation efforts to alleviate distress. Items are rated on a scale ranging from 1 (strongly agree) to 5 (strongly disagree). Total score range from 15 to 75, with higher scores reflecting higher levels of distress tolerance.
Time frame: The DTS will be administered at the baseline assessment and at one- and three-month follow-ups
Population: Differences between number of participants analyzed and pt data reported at subsequent timepoints is due to dropout. Pts completed the MDAS and ADIS at the same time they were enrolled by study staff. However, secondary measures such as the DTS were given to pts to complete independently before the intervention visit. Participants who did not attend the intervention visit were unlikely to complete these measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychology Intervention | Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | 1 Month | 47.6 score on a scale | Standard Deviation 13.5 |
| Psychology Intervention | Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | Baseline | 45.6 score on a scale | Standard Deviation 12.8 |
| Psychology Intervention | Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | 3 Months | 49.3 score on a scale | Standard Deviation 15 |
| Dental Intervention | Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | 1 Month | 46.3 score on a scale | Standard Deviation 13.8 |
| Dental Intervention | Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | Baseline | 44.9 score on a scale | Standard Deviation 12.6 |
| Dental Intervention | Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | 3 Months | 47.2 score on a scale | Standard Deviation 13.7 |
| Control | Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | Baseline | 43.7 score on a scale | Standard Deviation 14 |
| Control | Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | 3 Months | 47 score on a scale | Standard Deviation 13.7 |
| Control | Distress Tolerance Scale (DTS; Simons & Gaher, 2005). | 1 Month | 46.1 score on a scale | Standard Deviation 14.4 |
Secondary
Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979).
The FQ-BII is a 5-item subscale of the complete FQ. It assesses the degree to which an individual avoids situations involving blood-injury-injection because of fear, including in the context of dental procedures. Items are rated on a scale ranging from 0 (would not avoid it) to 8 (would always avoid it). Total scores range from 0-40 with higher scores indicating greater phobic avoidance.
Time frame: It will be administered at the baseline assessment and at one- and three-month follow-ups.
Population: Differences between number of participants analyzed and pt data reported at subsequent timepoints is due to dropout. Pts completed the MDAS and ADIS at the same time they were enrolled by study staff. However, secondary measures such as the FQBII were given to pts to complete independently before the intervention visit. Participants who did not attend the intervention visit were unlikely to complete these measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychology Intervention | Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | 1 Month | 47.6 score on a scale | Standard Deviation 13.5 |
| Psychology Intervention | Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | Baseline | 45.6 score on a scale | Standard Deviation 12.8 |
| Psychology Intervention | Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | 3 Months | 49.3 score on a scale | Standard Deviation 15 |
| Dental Intervention | Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | 1 Month | 46.3 score on a scale | Standard Deviation 13.8 |
| Dental Intervention | Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | Baseline | 44.9 score on a scale | Standard Deviation 12.6 |
| Dental Intervention | Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | 3 Months | 47.2 score on a scale | Standard Deviation 13.7 |
| Control | Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | Baseline | 43.7 score on a scale | Standard Deviation 14 |
| Control | Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | 3 Months | 47.0 score on a scale | Standard Deviation 13.7 |
| Control | Fear Questionnaire Blood-Injury-Injection Subscale (FQ-BII; Marks & Mathews, 1979). | 1 Month | 46.1 score on a scale | Standard Deviation 14.4 |
Secondary
Pain Intensity Numeric Rating Scale (PI-NRS).
The PI-NRS is a widely utilized 11-point self-report measure that assesses physical pain intensity on a scale ranging from 0 (no pain) to 10 (worst possible pain). Anxiety increases subjective pain experience, and therefore this scale will be used to assess the intensity of dental-related pain that participants expect to experience at their dental appointment scheduled after the dental anxiety intervention (or control), the intensity of pain they actually experienced, and the intensity of pain they expect to experience at their next similar dental appointment.
Time frame: These ratings will be administered as part of the post-appointment debriefing interview, as well as at the 1-month and 3-month follow-ups.
Population: The question, How much pain do you expect to experience during your next similar dental procedure? was asked to pts as part of the PI-NRS following their dental appointment, at 1-month, and at 3-months follow up.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 5 | 7 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 9 | 0 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 4 - Moderate Pain | 14 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 6 - Severe Pain | 5 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 5 | 9 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 3 | 11 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 7 | 2 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 4 - Moderate Pain | 23 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 2 - Mild Pain | 9 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 8 - Very Severe Pain | 3 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 0 - No pain | 9 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 1 | 8 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 9 | 0 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 10 - Worst Possible Pain | 2 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 0 - No pain | 21 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 10 - Worst Possible Pain | 4 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 2 - Mild Pain | 33 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 10 - Worst Possible Pain | 10 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 0 - No pain | 12 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 7 | 0 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 9 | 4 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 1 | 11 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 3 | 7 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 8 - Very Severe Pain | 1 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 2 - Mild Pain | 25 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 8 - Very Severe Pain | 1 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 7 | 2 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 3 | 14 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 6 - Severe Pain | 9 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 6 - Severe Pain | 11 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 4 - Moderate Pain | 22 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 1 | 11 Participants |
| Psychology Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 5 | 13 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 6 - Severe Pain | 13 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 5 | 9 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 6 - Severe Pain | 7 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 7 | 4 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 8 - Very Severe Pain | 8 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 9 | 0 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 10 - Worst Possible Pain | 2 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 0 - No pain | 14 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 1 | 10 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 2 - Mild Pain | 18 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 3 | 10 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 4 - Moderate Pain | 24 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 5 | 11 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 7 | 2 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 8 - Very Severe Pain | 1 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 9 | 0 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 10 - Worst Possible Pain | 3 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 3 | 9 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 0 - No pain | 16 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 1 | 10 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 2 - Mild Pain | 16 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 4 - Moderate Pain | 12 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 5 | 13 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 6 - Severe Pain | 9 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 7 | 3 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 8 - Very Severe Pain | 8 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 9 | 2 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 10 - Worst Possible Pain | 9 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 0 - No pain | 12 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 1 | 12 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 2 - Mild Pain | 23 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 3 | 4 Participants |
| Dental Intervention | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 4 - Moderate Pain | 27 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 4 - Moderate Pain | 26 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 3 | 10 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 5 | 18 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 3 | 10 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 1 | 11 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 6 - Severe Pain | 8 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 2 - Mild Pain | 24 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 6 - Severe Pain | 12 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 7 | 9 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 1 | 11 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 7 | 7 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 8 - Very Severe Pain | 11 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 0 - No pain | 9 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 2 - Mild Pain | 21 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 9 | 3 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 10 - Worst Possible Pain | 4 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 5 | 12 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 10 - Worst Possible Pain | 2 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 3 | 12 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 10 - Worst Possible Pain | 16 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 9 | 1 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 9 | 0 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 0 - No pain | 12 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 8 - Very Severe Pain | 5 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 4 - Moderate Pain | 24 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 1 | 4 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 7 | 4 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 0 - No pain | 11 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 2 - Mild Pain | 19 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 6 - Severe Pain | 5 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 3-Month Follow Up | 5 | 19 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | 1-Month Follow Up | 8 - Very Severe Pain | 5 Participants |
| Control | Pain Intensity Numeric Rating Scale (PI-NRS). | Post-Appointment | 4 - Moderate Pain | 14 Participants |
Secondary
Pain Sensitivity Index (PSI; Gross, 1992a).
The PSI is a 16-item self-report measure that assesses the fearful appraisal of pain and the expected physical, psychological, and social consequences of pain. Items are rated on a scale ranging from 0 (not at all) to 7 (very much) reflecting the degree to which the item applies to the respondent. Higher scores indicate higher levels of pain sensitivity. The minimum PSI score is 0, while the maximum PSI score is 112.
Time frame: It will be administered at baseline and the 1-month and 3-month follow-ups.
Population: Differences between number of participants analyzed and pt data reported at subsequent timepoints is due to dropout. Pts completed the MDAS and ADIS at the same time they were enrolled by study staff. However, secondary measures such as the PSI were given to pts to complete independently before the intervention visit. Participants who did not attend the intervention visit were unlikely to complete these measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychology Intervention | Pain Sensitivity Index (PSI; Gross, 1992a). | 1 Month | 58.6 score on a scale | Standard Deviation 24.3 |
| Psychology Intervention | Pain Sensitivity Index (PSI; Gross, 1992a). | Baseline | 67.3 score on a scale | Standard Deviation 23.2 |
| Psychology Intervention | Pain Sensitivity Index (PSI; Gross, 1992a). | 3 Months | 55.3 score on a scale | Standard Deviation 26.5 |
| Dental Intervention | Pain Sensitivity Index (PSI; Gross, 1992a). | 1 Month | 63.2 score on a scale | Standard Deviation 23.3 |
| Dental Intervention | Pain Sensitivity Index (PSI; Gross, 1992a). | Baseline | 68.4 score on a scale | Standard Deviation 21.6 |
| Dental Intervention | Pain Sensitivity Index (PSI; Gross, 1992a). | 3 Months | 56.9 score on a scale | Standard Deviation 23.9 |
| Control | Pain Sensitivity Index (PSI; Gross, 1992a). | Baseline | 68.4 score on a scale | Standard Deviation 24 |
| Control | Pain Sensitivity Index (PSI; Gross, 1992a). | 3 Months | 57.9 score on a scale | Standard Deviation 25.5 |
| Control | Pain Sensitivity Index (PSI; Gross, 1992a). | 1 Month | 62.8 score on a scale | Standard Deviation 25.1 |