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Virtual Reality Biofeedback for Postoperative Pain

N/A

Waitlist Available

Led By Vanessa Olbrecht, MD

Research Sponsored by Vanessa Olbrecht

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 12 -18 years

Scheduled to undergo surgery anticipated to cause moderate to severe pain with expected length of stay > or = to 2 days

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of study up to 30 days

Awards & highlights

Study Summary

This trial is investigating a new way to help children and adolescents prepare for and recover from surgery.

Who is the study for?

This trial is for children and adolescents aged 12-18 who are about to have surgery that will likely cause moderate to severe pain and require a hospital stay of at least two days. Participants must speak English, be managed by the Acute Pain Service, and have access to a mobile device or computer. It's not for those with developmental delays, uncontrolled psychiatric conditions, chronic pain, vertigo, seizures, severe motion sickness or those using opioids/benzodiazepines regularly.Check my eligibility

What is being tested?

The study is testing a new technology-based treatment protocol involving virtual reality as preoperative education/training and postoperative care for young patients undergoing surgery. The goal is to see if this approach can help manage their post-surgery pain better than current methods.See study design

What are the potential side effects?

Since this intervention involves virtual reality technology, potential side effects may include temporary discomfort like dizziness or nausea especially in individuals prone to motion sickness. However specific side effects related to the biofeedback aspect are not detailed.

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 am scheduled for surgery expected to cause significant pain and a hospital stay of 2 or more days.

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I am under the care of the Acute Pain Service for my pain management.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post intervention up to two weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post intervention up to two weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and post intervention up to two weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Aim 1: Treatment protocol refinement

Aim 2: Feasibility of technology intervention in perioperative patients

Secondary outcome measures

Aim 1: Post-operative session protocol

Aim 1: Preoperative training protocol

Aim 2: Effect of technology on anxiety

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Technology Based Intervention 2 (Phase 2)Experimental Treatment1 Intervention

Group II: Technology Based Intervention 1 (Phase 2)Experimental Treatment1 Intervention

Group III: Technology Based Intervention 1 (Phase 1)Experimental Treatment1 Intervention

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanessa OlbrechtLead Sponsor

1 Previous Clinical Trials

800 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

834 Previous Clinical Trials

669,375 Total Patients Enrolled

1 Trials studying Postoperative Pain

54 Patients Enrolled for Postoperative Pain

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,498 Total Patients Enrolled

2 Trials studying Postoperative Pain

1,700 Patients Enrolled for Postoperative Pain

Media Library

Technology Based Intervention 1 (Phase 1) Clinical Trial Eligibility Overview. Trial Name: NCT04943874 — N/A

Postoperative Pain Research Study Groups: Technology Based Intervention 1 (Phase 1), Technology Based Intervention 1 (Phase 2), Technology Based Intervention 2 (Phase 2)

Postoperative Pain Clinical Trial 2023: Technology Based Intervention 1 (Phase 1) Highlights & Side Effects. Trial Name: NCT04943874 — N/A

Technology Based Intervention 1 (Phase 1) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04943874 — N/A

Frequently Asked Questions

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

Are persons aged 70 and under admissible to this experiment?

"This clinical study is recruiting patients between 12 and 18 years of age. According to the records, there are 179 trials that cater exclusively to adolescents while 905 focus on elderly individuals."

Answered by AI

Is recruitment for this trial still open?

"According to the clinicaltrials.gov entry, recruitment for this trial has concluded; it was initially posted on March 10th 2022 and last updated April 26th 2022. Fortunately, 1157 other trials are enrolling patients right now."

Answered by AI

Do I meet the criteria for inclusion in this research project?

"To join this medical study, participants should be in the age range of 12 to 18 and have documented cases of acute pain. Approximately 70 patients are being considered for enrolment."

Answered by AI

What are the anticipated outcomes of this research endeavor?

"This 30-day medical trial is primarily targeting the feasibility of technology intervention in perioperative patients. Secondary objectives include a preoperative training protocol, self-reported outcomes from semi-structured interviews and measuring anxiety levels between 0 and 10 (0 being no anxiety, 10 being severe)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain

Vanessa Olbrecht 2022. "Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04943874.

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