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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
Must not have
History of chronic pain
Conditions such as craniofacial abnormalities or surgeries of the head and neck
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study up to 30 days
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a long-term history of pain.
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I have had surgery or have abnormalities in my head or neck area.
Select...
I have no history of severe developmental delays, uncontrolled psychiatric conditions with hallucinations or delusions, or major neurological issues.
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I have a history of vertigo, seizures, or severe motion sickness.
Select...
I am currently experiencing nausea or vomiting.
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I do not speak English.
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I am either younger than 12 or older than 18 years old.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Aim 1: Treatment protocol refinement
Aim 2: Feasibility of technology intervention in perioperative patients
Secondary study objectives
Aim 1: Post-operative session protocol
Aim 1: Preoperative training protocol
Aim 2: Effect of technology on anxiety
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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
862 Previous Clinical Trials
674,008 Total Patients Enrolled
1 Trials studying Postoperative Pain
60 Patients Enrolled for Postoperative Pain
Children's Hospital Medical Center, CincinnatiLead Sponsor
839 Previous Clinical Trials
6,565,524 Total Patients Enrolled
2 Trials studying Postoperative Pain
1,700 Patients Enrolled for Postoperative Pain
Vanessa Olbrecht, MDPrincipal InvestigatorNationwide Children's Hospital
4 Previous Clinical Trials
301 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a long-term history of pain.I have had surgery or have abnormalities in my head or neck area.I have no history of severe developmental delays, uncontrolled psychiatric conditions with hallucinations or delusions, or major neurological issues.I have a history of vertigo, seizures, or severe motion sickness.I am between 12 and 18 years old.I am scheduled for surgery expected to cause significant pain and a hospital stay of 2 or more days.I am under the care of the Acute Pain Service for my pain management.I am currently experiencing nausea or vomiting.You are regularly taking opioids or benzodiazepines for pain management.I do not speak English.I am either younger than 12 or older than 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Technology Based Intervention 1 (Phase 1)
- Group 2: Technology Based Intervention 1 (Phase 2)
- Group 3: Technology Based Intervention 2 (Phase 2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.