Recruitment and Behavioral Economic Strategies

Not Applicable

Terminated

Conditions: Adolescent Behavior
Surgery

Interventions: Behavioral: Behavioral Economics (BE) recruitment strategies
Other: Manage My Pain
Other: Biofeedback-based virtual reality (VR-BF)

Registration Number: NCT05441579

Lead Sponsor: Vanessa Olbrecht

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 128

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 1 - VR-BF BE	Behavioral Economics (BE) recruitment strategies	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.
Phase 2 - Manage My Pain BE	Manage My Pain	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 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application.
Phase 2 - Manage My Pain Biological	Manage My Pain	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 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application.
Phase 1 - VR-BF BE	Biofeedback-based virtual reality (VR-BF)	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.
Phase 1 - VR-BF Biological	Biofeedback-based virtual reality (VR-BF)	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.
Phase 2 - Manage My Pain BE	Behavioral Economics (BE) recruitment strategies	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 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.