Adolescent Behavior, Surgery
Conditions
Brief summary
To determine the impact of the application of behavioral economic strategies on recruitment of pediatric patients into a randomized clinical trial assessing the impact of technology-based interventions on postoperative pain management.
Detailed description
Patients will be asked to watch one of two videos in either Phase 1 or Phase 2 relating to recruitment and fill out a survey to determine their likelihood to enroll in a research study. Patients 12-18 years of age presenting for surgery that requires postoperative admission and usually requires narcotic administration.
Interventions
BEHAVIORALBehavioral Economics (BE) recruitment strategies
Behavioral economics (BE), a method of economic analysis that applies psychological insights into human behavior to explain economic decision-making, has broad applicability and its techniques offer a novel way that may be applied to try to help enhance study recruitment and enrollment.
OTHERBiofeedback-based virtual reality (VR-BF)
Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
OTHERManage My Pain
Commercially available and free app to track, analyze and monitor pain.
Sponsors
Vanessa Olbrecht
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients between the ages of 12-18 years of age * Patients able to read, understand, and speak English * Patients undergoing surgery requiring postoperative admission * Patients undergoing surgery that requires narcotic administration
Exclusion criteria
* Patients outside of the age range * Patients with history of developmental delay, uncontrolled psychiatric conditions, or neurological conditions (i.e., epilepsy, motion sickness, nausea/vomiting) * History of severe vertigo or dizziness * History of chronic pain * Patients that use opioids or benzodiazepines chronically * Patients with conditions that would preclude placement of a VR headset, including craniofacial abnormalities or undergoing surgeries of the head and neck.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Impact of the Application of Behavioral Economic Strategies on Recruitment of Pediatric Patients Into a Randomized Clinical Trial Assessing the Impact of Technology-based Interventions on Postoperative Pain Management. | Baseline | Survey to identify likelihood to participate in study using a 5-point Likert scale (1=Extremely Unlikely to 5=Extremely Likely). |
| Willingness to Participate in Clinical Trial | Baseline | If given the opportunity, would you participate in the clinical trial? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perception of Efficacy - Less Pain | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I believe this technology would help me have less pain after surgery. |
| Perception of Risk - Side Effects | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I am worried that this technology would have a lot of side effects. |
| Opinion of Treatment Burden - Ease of Use | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I feel that this technology would be easy to use. |
| Intention to Adhere to Therapy - Would Use | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would use this technology at least once per day after surgery while I was still needing it. |
| Acceptability of Therapy - Pain Medication | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would like to use this technology to help me take less pain medication. |
| Acceptability of Therapy - Recommend to Others | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would recommend this therapy to other individuals undergoing surgery. |
| Intention to Adhere to Therapy - Would Practice | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would practice this technology at least once per day before surgery. |
| Perception of Efficacy - Less Pain Medication | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I believe that this technology would help me use less pain medication after surgery. |
| Perception of Risk - Amount | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I believe that this technology would be too risky for me to use. |
| Opinion of Treatment Burden - Independence | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would feel comfortable using this technology independently without supervision. |
| Opinion of Treatment Burden - Familiar | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I am familiar with how to use this type of technology. |
| Opinion of Treatment Burden - Pay for Technology | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would pay for the opportunity to use this technology during my recovery. I am comfortably using technologies like this. |
| Opinion of Treatment Burden - Technology Comfort | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I am comfortably using technologies like this. |
| Acceptability of Therapy - Preference | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would prefer using this technology over taking pain medications. |
| Acceptability of Therapy - Excitement | Baseline | Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would be excited to use this technology. |
Countries
United States
Participant flow
Pre-assignment details
Phase 2 was not initiated and was discontinued due to statistical futility.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 - VR-BF BE We are applying Behavioral Economics (BE)-based messaging and presentation strategies to patient recruitment and determining whether these strategies may enhance patient recruitment into a pediatric randomized clinical trial. Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
Behavioral Economics (BE) recruitment strategies: Behavioral economics (BE), a method of economic analysis that applies psychological insights into human behavior to explain economic decision-making, has broad applicability and its techniques offer a novel way that may be applied to try to help enhance study recruitment and enrollment.
Biofeedback-based virtual reality (VR-BF): Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm. | 64 |
| Phase 1 - VR-BF Biological A similar to BE-based recruitment video using a standard biological approach on teenagers' decision to enroll in a clinical study will be used as comparison. Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
Biofeedback-based virtual reality (VR-BF): Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm. | 64 |
| Total | 128 |
Baseline characteristics
| Characteristic | Phase 1 - VR-BF BE | Phase 1 - VR-BF Biological | Total |
|---|---|---|---|
| Age, Continuous | 14.7 years STANDARD_DEVIATION 1.6 | 14.6 years STANDARD_DEVIATION 1.6 | 14.7 years STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants | 61 Participants | 121 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Previous pain management Acupuncture | 1 Participants | 1 Participants | 2 Participants |
| Previous pain management Chiropractor | 6 Participants | 4 Participants | 10 Participants |
| Previous pain management Deep breathing, meditation, guided imagery, relaxation or similar approach | 9 Participants | 16 Participants | 25 Participants |
| Previous pain management Have not had pain in the past | 0 Participants | 0 Participants | 0 Participants |
| Previous pain management Massage | 7 Participants | 13 Participants | 20 Participants |
| Previous pain management Other | 3 Participants | 4 Participants | 7 Participants |
| Previous pain management Over-the-counter pain medication | 59 Participants | 58 Participants | 117 Participants |
| Previous pain management Prescribed pain medication | 13 Participants | 20 Participants | 33 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 50 Participants | 53 Participants | 103 Participants |
| Region of Enrollment United States | 64 participants | 64 participants | 128 participants |
| Sex/Gender, Customized Female | 32 Participants | 31 Participants | 63 Participants |
| Sex/Gender, Customized Male | 31 Participants | 33 Participants | 64 Participants |
| Sex/Gender, Customized Prefer not to answer | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 64 |
| other Total, other adverse events | 0 / 64 | 0 / 64 |
| serious Total, serious adverse events | 0 / 64 | 0 / 64 |
Outcome results
Primary
To Determine the Impact of the Application of Behavioral Economic Strategies on Recruitment of Pediatric Patients Into a Randomized Clinical Trial Assessing the Impact of Technology-based Interventions on Postoperative Pain Management.
Survey to identify likelihood to participate in study using a 5-point Likert scale (1=Extremely Unlikely to 5=Extremely Likely).
Time frame: Baseline
Population: Two participants from the standard recruitment video group did not respond to questions related to this outcome.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Phase 1 - VR-BF BE | To Determine the Impact of the Application of Behavioral Economic Strategies on Recruitment of Pediatric Patients Into a Randomized Clinical Trial Assessing the Impact of Technology-based Interventions on Postoperative Pain Management. | Interest in using ForeVR | 4 score on a scale |
| Phase 1 - VR-BF BE | To Determine the Impact of the Application of Behavioral Economic Strategies on Recruitment of Pediatric Patients Into a Randomized Clinical Trial Assessing the Impact of Technology-based Interventions on Postoperative Pain Management. | Interest in participating in clinical trial involving ForeVR | 3 score on a scale |
| Phase 1 - VR-BF Biological | To Determine the Impact of the Application of Behavioral Economic Strategies on Recruitment of Pediatric Patients Into a Randomized Clinical Trial Assessing the Impact of Technology-based Interventions on Postoperative Pain Management. | Interest in using ForeVR | 4 score on a scale |
| Phase 1 - VR-BF Biological | To Determine the Impact of the Application of Behavioral Economic Strategies on Recruitment of Pediatric Patients Into a Randomized Clinical Trial Assessing the Impact of Technology-based Interventions on Postoperative Pain Management. | Interest in participating in clinical trial involving ForeVR | 4 score on a scale |
Primary
Willingness to Participate in Clinical Trial
If given the opportunity, would you participate in the clinical trial?
Time frame: Baseline
Population: Two participants from the standard recruitment video group did not respond to questions related to this outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 - VR-BF BE | Willingness to Participate in Clinical Trial | Yes | 48 Participants |
| Phase 1 - VR-BF BE | Willingness to Participate in Clinical Trial | No | 16 Participants |
| Phase 1 - VR-BF Biological | Willingness to Participate in Clinical Trial | Yes | 49 Participants |
| Phase 1 - VR-BF Biological | Willingness to Participate in Clinical Trial | No | 13 Participants |
Secondary
Acceptability of Therapy - Excitement
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would be excited to use this technology.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Acceptability of Therapy - Excitement | 4 score on a Likert scale |
| Phase 1 - VR-BF Biological | Acceptability of Therapy - Excitement | 4 score on a Likert scale |
Secondary
Acceptability of Therapy - Pain Medication
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would like to use this technology to help me take less pain medication.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Acceptability of Therapy - Pain Medication | 4 score on a Likert scale |
| Phase 1 - VR-BF Biological | Acceptability of Therapy - Pain Medication | 4 score on a Likert scale |
Secondary
Acceptability of Therapy - Preference
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would prefer using this technology over taking pain medications.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Acceptability of Therapy - Preference | 4 score on a Likert scale |
| Phase 1 - VR-BF Biological | Acceptability of Therapy - Preference | 4 score on a Likert scale |
Secondary
Acceptability of Therapy - Recommend to Others
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would recommend this therapy to other individuals undergoing surgery.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Acceptability of Therapy - Recommend to Others | 4 score on a Likert scale |
| Phase 1 - VR-BF Biological | Acceptability of Therapy - Recommend to Others | 4 score on a Likert scale |
Secondary
Intention to Adhere to Therapy - Would Practice
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would practice this technology at least once per day before surgery.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Intention to Adhere to Therapy - Would Practice | 4 score on a Likert scale |
| Phase 1 - VR-BF Biological | Intention to Adhere to Therapy - Would Practice | 4 score on a Likert scale |
Secondary
Intention to Adhere to Therapy - Would Use
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would use this technology at least once per day after surgery while I was still needing it.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Intention to Adhere to Therapy - Would Use | 4 score on a Likert scale |
| Phase 1 - VR-BF Biological | Intention to Adhere to Therapy - Would Use | 4 score on a Likert scale |
Secondary
Opinion of Treatment Burden - Ease of Use
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I feel that this technology would be easy to use.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Opinion of Treatment Burden - Ease of Use | 3 score on a Likert scale |
| Phase 1 - VR-BF Biological | Opinion of Treatment Burden - Ease of Use | 4 score on a Likert scale |
Secondary
Opinion of Treatment Burden - Familiar
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I am familiar with how to use this type of technology.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Opinion of Treatment Burden - Familiar | 3 score on a Likert scale |
| Phase 1 - VR-BF Biological | Opinion of Treatment Burden - Familiar | 4 score on a Likert scale |
Secondary
Opinion of Treatment Burden - Independence
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would feel comfortable using this technology independently without supervision.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Opinion of Treatment Burden - Independence | 3 score on a Likert scale |
| Phase 1 - VR-BF Biological | Opinion of Treatment Burden - Independence | 4 score on a Likert scale |
Secondary
Opinion of Treatment Burden - Pay for Technology
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I would pay for the opportunity to use this technology during my recovery. I am comfortably using technologies like this.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Opinion of Treatment Burden - Pay for Technology | 3 score on a Likert scale |
| Phase 1 - VR-BF Biological | Opinion of Treatment Burden - Pay for Technology | 4 score on a Likert scale |
Secondary
Opinion of Treatment Burden - Technology Comfort
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I am comfortably using technologies like this.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Opinion of Treatment Burden - Technology Comfort | 3 score on a Likert scale |
| Phase 1 - VR-BF Biological | Opinion of Treatment Burden - Technology Comfort | 4 score on a Likert scale |
Secondary
Perception of Efficacy - Less Pain
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I believe this technology would help me have less pain after surgery.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Perception of Efficacy - Less Pain | 3 score on a Likert scale |
| Phase 1 - VR-BF Biological | Perception of Efficacy - Less Pain | 3 score on a Likert scale |
Secondary
Perception of Efficacy - Less Pain Medication
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I believe that this technology would help me use less pain medication after surgery.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Perception of Efficacy - Less Pain Medication | 3 score on a Likert scale |
| Phase 1 - VR-BF Biological | Perception of Efficacy - Less Pain Medication | 3 score on a Likert scale |
Secondary
Perception of Risk - Amount
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I believe that this technology would be too risky for me to use.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Perception of Risk - Amount | 2 score on a Likert scale |
| Phase 1 - VR-BF Biological | Perception of Risk - Amount | 2 score on a Likert scale |
Secondary
Perception of Risk - Side Effects
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1=Strongly Disagree to 5= Strongly Agree): I am worried that this technology would have a lot of side effects.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 - VR-BF BE | Perception of Risk - Side Effects | 2 score on a Likert scale |
| Phase 1 - VR-BF Biological | Perception of Risk - Side Effects | 2 score on a Likert scale |