Trial Outcomes & Findings for Recruitment and Behavioral Economic Strategies (NCT NCT05441579)

Last Updated: 2024-12-20

Results Overview

Survey to identify likelihood to participate in study using a 5-point Likert scale (1="Extremely Unlikely" to 5="Extremely Likely").

Recruitment status

TERMINATED

Study phase

Target enrollment

128 participants

Primary outcome timeframe

Baseline

Results posted on

2024-12-20

Participant Flow

Phase 2 was not initiated and was discontinued due to statistical futility.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	64	64
Overall Study COMPLETED	64	64
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Recruitment and Behavioral Economic Strategies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.	Total n=128 Participants Total of all reporting groups
Age, Continuous	14.7 years STANDARD_DEVIATION 1.6 • n=5 Participants	14.6 years STANDARD_DEVIATION 1.6 • n=7 Participants	14.7 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex/Gender, Customized Male	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Sex/Gender, Customized Female	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Sex/Gender, Customized Prefer not to answer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants	61 Participants n=7 Participants	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants	64 participants n=7 Participants	128 participants n=5 Participants
Previous pain management Over-the-counter pain medication	59 Participants n=5 Participants	58 Participants n=7 Participants	117 Participants n=5 Participants
Previous pain management Massage	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Previous pain management Acupuncture	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Previous pain management Chiropractor	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Previous pain management Prescribed pain medication	13 Participants n=5 Participants	20 Participants n=7 Participants	33 Participants n=5 Participants
Previous pain management Deep breathing, meditation, guided imagery, relaxation or similar approach	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Previous pain management Have not had pain in the past	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Previous pain management Other	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Two participants from the standard recruitment video group did not respond to questions related to this outcome.

Survey to identify likelihood to participate in study using a 5-point Likert scale (1="Extremely Unlikely" to 5="Extremely Likely").

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=62 Participants 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.
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 Interval 3.0 to 4.0	4 score on a scale Interval 3.0 to 4.0
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 Interval 3.0 to 4.0	4 score on a scale Interval 3.0 to 4.0

PRIMARY outcome

Timeframe: Baseline

Population: Two participants from the standard recruitment video group did not respond to questions related to this outcome.

If given the opportunity, would you participate in the clinical trial?

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=62 Participants 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.
Willingness to Participate in Clinical Trial Yes	48 Participants	49 Participants
Willingness to Participate in Clinical Trial No	16 Participants	13 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Intention to Adhere to Therapy - Would Practice	4 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Acceptability of Therapy - Excitement	4 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Perception of Efficacy - Less Pain	3 score on a Likert scale Interval 3.0 to 4.0	3 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Perception of Risk - Side Effects	2 score on a Likert scale Interval 1.0 to 2.0	2 score on a Likert scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Opinion of Treatment Burden - Ease of Use	3 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Intention to Adhere to Therapy - Would Use	4 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Acceptability of Therapy - Pain Medication	4 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Acceptability of Therapy - Recommend to Others	4 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Acceptability of Therapy - Preference	4 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Perception of Efficacy - Less Pain Medication	3 score on a Likert scale Interval 3.0 to 4.0	3 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Perception of Risk - Amount	2 score on a Likert scale Interval 1.0 to 2.0	2 score on a Likert scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Opinion of Treatment Burden - Independence	3 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Opinion of Treatment Burden - Familiar	3 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Opinion of Treatment Burden - Pay for Technology	3 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1 - VR-BF BE n=64 Participants 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.	Phase 1 - VR-BF Biological n=64 Participants 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.
Opinion of Treatment Burden - Technology Comfort	3 score on a Likert scale Interval 3.0 to 4.0	4 score on a Likert scale Interval 3.0 to 4.0

Adverse Events

Phase 1 - VR-BF BE

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 1 - VR-BF Biological

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Vanessa Olbrecht

Nationwide Children's Hospital

Phone: 614-722-4200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place