Technology-Based Interventions for Postoperative Pain in Children

Overseen By Julie Rice-Weimer, RN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Vanessa Olbrecht

Must not be taking: Opioids, Benzodiazepines

Disqualifiers: Developmental delay, Uncontrolled psychiatric, Neurological, others

Compensation: Varies

Number of Visits: Unknown

128 Participants Needed

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

Patients able to read, understand, and speak English

I am between 12 and 18 years old.

I will need narcotics for pain management during 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.

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

Group I: Phase 2 - Manage My Pain BE Experimental Treatment 2 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 BE Experimental Treatment 2 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 Biological Active Control 1 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 Biological Placebo Group 1 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.

Who Is Running the Clinical Trial?

Vanessa Olbrecht

Lead Sponsor

Trials

2

Recruited

220+