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Technology-Based Interventions for Postoperative Pain in Children

N/A
Waitlist Available
Research Sponsored by Vanessa Olbrecht
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients between the ages of 12-18 years of age
Patients undergoing surgery that requires narcotic administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial will assess whether technology-based interventions can help reduce postoperative pain in children, and whether using behavioral economic strategies can help recruit pediatric patients into the trial.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the VR headset after head/neck surgeries or experiencing motion sickness with VR use. The 'Manage My Pain' app itself does not have physical side effects but could impact patient behavior regarding pain management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 18 years old.
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I will need narcotics for pain management during my surgery.
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I will be staying in the hospital after my surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Vanessa OlbrechtLead Sponsor
1 Previous Clinical Trials
93 Total Patients Enrolled

Media Library

Manage My Pain Clinical Trial Eligibility Overview. Trial Name: NCT05441579 — N/A
Adolescent Behaviors Research Study Groups: Phase 1 - VR-BF BE, Phase 2 - Manage My Pain BE, Phase 2 - Manage My Pain Biological, Phase 1 - VR-BF Biological
Adolescent Behaviors Clinical Trial 2023: Manage My Pain Highlights & Side Effects. Trial Name: NCT05441579 — N/A
Manage My Pain 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441579 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment accept participants over the age of 18?

"According to the specified requirements of this study, participants must be aged between 12 and 18 years old."

Answered by AI

What is the total sample size of participants enrolled in this clinical trial?

"Affirmative. The clinical trial is actively seeking participants, as evidenced by the information on clinicaltrials.gov. This research project was initially uploaded to the website on May 17th 2022 and has since been updated for a final time June 28th that same year. Out of 1 medical facility 800 patients need to be recruited."

Answered by AI

For whom is enrollment available in this research investigation?

"This clinical trial is open to those aged 12-18 years old who are scheduled for a surgical procedure that necessitates narcotic medication and postoperative hospitalization. 800 individuals will be included in the study in total."

Answered by AI

Are recruitment efforts for this experiment ongoing?

"Data on clinicaltrials.gov confirms that, as of this moment, recruitment for this medical trial is ongoing. The study was initially shared to the public on May 17th 2022 and has been amended most recently on June 28th 2022."

Answered by AI
~274 spots leftby May 2025