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: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests technology-based methods to help children manage pain after surgery. Researchers aim to determine if virtual reality or a pain management app can make a difference. They also examine how different recruitment strategies, using Behavioral Economics (BE), affect children's decisions to participate. Children aged 12-18 who are undergoing surgery and will need pain medication afterward might be suitable for this study. The trial seeks to improve post-surgery recovery by making pain management easier and more effective. As an unphased trial, it offers a unique opportunity to explore innovative pain management solutions and contribute to advancements in pediatric care.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you use opioids or benzodiazepines regularly, you cannot participate in the trial.

What prior data suggests that these technology-based interventions are safe for children?

Research has shown that behavioral economic strategies are safe for recruiting participants in clinical trials. Several studies have compared these strategies to traditional methods to determine their effectiveness in encouraging children to join trials. These strategies focus on how information is shared and presented to make the trial more appealing.

Although new in this setting, these strategies do not involve drugs or physical treatments, so they lack the same safety risks. No reports of negative effects have emerged from the available studies, suggesting that these methods are well-tolerated and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses Behavioral Economics (BE)-based strategies to enhance patient recruitment for managing postoperative pain in children, a new approach compared to traditional recruitment methods. This trial is testing if BE can make recruitment for pediatric pain management trials more effective by tailoring messaging and presentation strategies. By focusing on engaging patients through innovative techniques like virtual reality and mobile applications, the trial aims to improve trial participation and outcomes, potentially setting new standards for how future clinical trials are conducted in pediatric pain management.

What evidence suggests that this trial's technology-based interventions could be effective for managing postoperative pain in children?

Research has shown that behavioral economics (BE) strategies can significantly influence the interest of children and their parents in joining clinical trials. These strategies use innovative communication and information-sharing techniques to make trials more appealing. Past studies have demonstrated that BE recruitment methods increase participation compared to traditional methods, leading to more children and families agreeing to join these important studies. In this trial, researchers are testing BE strategies to enhance recruitment for two separate interventions: a biofeedback-based virtual reality (VR-BF) arm and a control intervention using the Manage My Pain application, both focused on managing pain for children after surgery. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/pan.14755

Application of behavioral economic strategies to enhance ... This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37712489/

Application of behavioral economic strategies to enhance ... This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial.

3. researchgate.net researchgate.net/publication/373965642_Application_of_behavioral_economic_strategies_to_enhance_recruitment_into_a_pediatric_randomized_clinical_trial_for_postoperative_pain_relief_A_randomized_clinical_trial

Application of behavioral economic strategies to enhance ... This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial ...

4. researchgate.net researchgate.net/scientific-contributions/Anitra-Karthic-2241959637

Anitra Karthic's research works | The Ohio State University ... This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized clinical trial ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11325993/

Enhancing pediatric postoperative pain management Behavioral interventions focus on reducing pain stimuli by providing a comfortable environment, avoiding bright lights, noise, and excessive touching. In ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/pdf/10.1111/pan.14755

A randomized clinical trial This study assessed the impact of behavioral economic strategies versus a standard biological approach to recruit children into a randomized ...

7. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-025-02941-2

Barriers and facilitators of pain management in children This study presented a comprehensive scoping review of the barriers and facilitators to pediatric pain management, synthesizing findings from ...