Dental Anxiety, Intellectual and Developmental Disabilities
Conditions
Brief summary
Adults with intellectual and developmental disabilities may experience behavioral distress, sensory sensitivity, and difficulty tolerating dental procedures. This pilot randomized controlled trial will compare live music therapy delivered by a board certified music therapist with recorded music during non emergency dental procedures performed under local anesthesia. Approximately 50 participants will be enrolled to obtain 40 evaluable participants randomized in a 1:1 ratio. The study will evaluate the feasibility and acceptability of live music therapy and its preliminary effects on behavioral cooperation, procedural distress, physiological responses, completion of dental treatment without escalation to sedation, and procedure duration.
Interventions
BEHAVIORALLive Music Therapy
Live music therapy will be delivered by a board certified music therapist before, during, and after the dental procedure as appropriate. Techniques may include live singing with guitar accompaniment, improvisation, music entrainment to breathing or heart rate, guided breathing synchronized with music, sung procedural cues, and participant engagement through instrument playing, singing, or vocal or instrumental improvisation. The intervention will be adapted in real time based on the participant's preferences, behavioral responses, physiological cues, and functional abilities.
BEHAVIORALRecorded Music
Prerecorded music will be delivered through a portable Bluetooth speaker positioned within the dental operatory. Music will begin before administration of local anesthesia and continue throughout the procedure unless discontinued at the participant's request. Participants may select relaxation oriented music or a preferred available genre. Volume will be adjusted for participant comfort while maintaining communication with the dental team.
Sponsors
University of Rochester
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years) with a documented I/DD, including Autism Spectrum Disorder (ASD), Intellectual Disability, ADHD, or other DSM-5-defined neurodevelopmental conditions. * Frankl Behavioral Rating Scale score of Negative (3) or Definitely Negative (4) at baseline assessment. * English as primary language. * Scheduled for non-emergency dental procedure with local anesthesia.
Exclusion criteria
* Unwillingness to participate or refusal to provide informed consent * Legal inability to consent * Disinterest in or refusal of music therapy intervention * Scheduled for pharmacological sedation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eligible Participants Who Consent to Participate | Throughout the recruitment period | Recruitment feasibility is calculated as the number of eligible participants who provide informed consent divided by the total number of eligible participants approached for participation, multiplied by 100. Possible values range from 0 to 100 percent. Higher percentages indicate greater recruitment feasibility. |
| Mean Total Caregiver Acceptability Questionnaire Score After the Dental Procedure | Immediately after the dental procedure | Caregiver reported acceptability is assessed using a 10 item questionnaire administered after the dental procedure. Each item is scored from 1 to 5. Items 1 through 9 range from 1, Not at all, to 5, Very much. Item 10 ranges from 1, Definitely no, to 5, Definitely yes. The 10 item scores are summed to produce a total score ranging from 10 to 50. Higher total scores indicate greater caregiver reported acceptability and perceived benefit of the music intervention. The outcome is the mean total score across caregiver respondents. |
| Percentage of Participants With Successful Physiological Monitoring During the Dental Procedure | From initiation of physiological monitoring through completion of the dental procedure | Physiological monitoring feasibility is calculated as the number of participants who successfully wear the required physiological monitoring device or devices as instructed throughout the dental procedure divided by the total number of participants undergoing physiological monitoring, multiplied by 100. Possible values range from 0 to 100 percent. Higher percentages indicate greater feasibility of physiological monitoring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Frankl Behavioral Rating Scale Score During the Dental Procedure | During the dental procedure | Behavioral cooperation is assessed using the Frankl Behavioral Rating Scale. Scores range from 1 to 4: 1 indicates Definitely Negative behavior, 2 indicates Negative behavior, 3 indicates Positive behavior, and 4 indicates Definitely Positive behavior. Higher scores indicate more positive behavior and greater cooperation during dental treatment. The outcome is the mean Frankl Behavioral Rating Scale score for each treatment group. |
| Mean Total Categorical Rating Scale Score During the Dental Procedure | During administration of local anesthesia and throughout the dental procedure | Procedural behavior and distress are assessed using the Categorical Rating Scale, which includes four domains: crying, cooperation, apprehension, and sleep. Each domain is scored from 1 to 4. For crying, scores range from 1, screaming, to 4, no crying. For cooperation, scores range from 1, violently resisting or disrupting treatment, to 4, no movement. For apprehension, scores range from 1, hysterical and disobeying instructions, to 4, calm, relaxed, and following instructions. For sleep, scores range from 1, fully awake, to 4, sound asleep. Scores for the four domains are summed at each assessment to produce a total score ranging from 4 to 16. When multiple assessments are obtained during the procedure, total scores are averaged across assessment time points to generate one procedure level score for each participant. The outcome is the mean procedure level total score for each treatment group. |
| Mean Heart Rate During the Dental Procedure | Approximately every 10 minutes during the dental procedure | Heart rate is measured by pulse oximetry approximately every 10 minutes during the dental procedure and recorded in beats per minute. For each participant, heart rate measurements collected during the procedure are averaged to generate one mean procedural heart rate. The outcome is the mean participant level heart rate for each treatment group. |
| Mean Peripheral Oxygen Saturation During the Dental Procedure | Approximately every 10 minutes during the dental procedure | Peripheral oxygen saturation is measured by pulse oximetry approximately every 10 minutes during the dental procedure and recorded as percent oxygen saturation. For each participant, oxygen saturation measurements collected during the procedure are averaged to generate one mean procedural oxygen saturation value. The outcome is the mean participant level oxygen saturation for each treatment group. |
| Mean BioDot Skin Temperature During the Dental Procedure | Approximately every 10 minutes during the dental procedure | Peripheral skin temperature is assessed using a BioDot skin thermometer approximately every 10 minutes during the dental procedure. The BioDot changes color according to skin temperature. Manufacturer reference values include amber at approximately 89.6 degrees Fahrenheit, yellow at 90.6 degrees Fahrenheit, green at 91.6 degrees Fahrenheit, turquoise at 92.6 degrees Fahrenheit, blue at 93.6 degrees Fahrenheit, and violet at 94.6 degrees Fahrenheit. Black indicates a temperature outside the measurable color range. Quantifiable readings collected during the procedure are averaged for each participant. The outcome is the mean participant level skin temperature for each treatment group. |
| Percentage of Participants Who Complete the Planned Dental Procedure Without Escalation to Sedation | During the dental procedure | Procedural completion is defined as completion of the planned dental procedure without escalation to pharmacological sedation. The outcome is calculated as the number of participants who complete the planned dental procedure without escalation to sedation divided by the total number of participants who undergo the study dental procedure, multiplied by 100. Possible values range from 0 to 100 percent. Higher percentages indicate a greater rate of procedural completion without escalation to sedation. |
| Mean Total Dental Procedure Duration | During the dental procedure | Total dental procedure duration is recorded in minutes for each participant from the start of the planned dental procedure through procedure completion. The outcome is the mean total procedural duration in minutes for each treatment group. |
Countries
United States
Contacts
CONTACTDana Benoit, MBA
PRINCIPAL_INVESTIGATORAdela Planerova
University of Rochester
Outcome results
None listed