128 Participants Needed

Technology-Based Interventions for Postoperative Pain in Children

CR
JR
Overseen ByJulie Rice-Weimer, RN

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for kids aged 12-18 who are having surgery that needs painkillers and a hospital stay. They must be able to read, understand, and speak English. It's not for those who regularly take opioids or benzodiazepines, have developmental delays, uncontrolled mental health issues, neurological conditions like epilepsy, history of chronic pain or severe vertigo.

Inclusion Criteria

I will need narcotics for pain management during my surgery.
I will be staying in the hospital after my surgery.

Exclusion Criteria

I have a long-term history of pain.
I am not within the specified age range for the trial.
I use opioids or benzodiazepines regularly.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 - VR-BF BE

Application of Behavioral Economics-based messaging and presentation strategies to enhance recruitment into a biofeedback-based virtual reality arm

Baseline
1 visit (in-person)

Phase 2 - Manage My Pain BE

Application of Behavioral Economics-based messaging and presentation strategies to enhance recruitment into the control arm with Manage My Pain application

Baseline
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Behavioral Economics (BE) recruitment strategies
Trial Overview The study tests if using behavioral economic strategies helps get more young patients into a trial. It also looks at how tech-based tools like virtual reality biofeedback (VR-BF) and an app called Manage My Pain affect post-surgery pain management.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Phase 2 - Manage My Pain BEExperimental Treatment2 Interventions
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.
Group II: Phase 1 - VR-BF BEExperimental Treatment2 Interventions
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.
Group III: Phase 1 - VR-BF BiologicalActive Control1 Intervention
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.
Group IV: Phase 2 - Manage My Pain BiologicalPlacebo Group1 Intervention
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.

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Who Is Running the Clinical Trial?

Vanessa Olbrecht

Lead Sponsor

Trials
2
Recruited
220+
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