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A treatment group that will have headset on and will watch a non-VR video for Broken Bones

N/A

Recruiting

Led By Peter D Fabricant, MD, MPH

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

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

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after intervention

Awards & highlights

Study Summary

This trial will study whether or not virtual reality can help ease pain and anxiety for children during outpatient procedures such as cast removal or surgical suture/pins removal. The child's heart rate will be monitored as a measure of pain and anxiety, as well as the child's and parent's satisfaction with the procedure.

Eligible Conditions

Broken Bones
Bone Deformity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 minutes pre-procedure until 1 minute post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 minutes pre-procedure until 1 minute post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 minutes pre-procedure until 1 minute post-procedure for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Absolute difference in HR as measured 3 minutes prior to procedure and maximum as measured during through 1 minute after procedure.

Secondary outcome measures

Difference in Visual Analogue Scale (VAS) anxiety score as measured 3 minutes before and immediately after intervention

Difference in Visual Analogue Scale (VAS) pain score as measured 3 minutes before and immediately after intervention

Parent/guardian post-procedure satisfaction questionnaire response

Trial Design

3Treatment groups

Experimental Treatment

Group I: A treatment group that will watch a non-VR video via an iPadExperimental Treatment1 Intervention

Demographic appropriate screening for inclusion ( including age and available past medical history) Patient consent (before randomization), iPad administration (description below), cast sawing, physical examination (before and after procedure), pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire procedure), NRS VAS pain administration (3 minutes pre-procedure and immediately post-procedure) in patients over 8 years(Will mark on scale), VAS Faces pain administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years (Will point to face), NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-procedure)(Will mark on scale), VAS Faces anxiety scale administration in patients under 8 years(Will point to face), Patient/parent satisfaction administration (post-procedure).

Group II: A treatment group that will have headset on and will watch a non-VR videoExperimental Treatment1 Intervention

Demographic appropriate screening for inclusion ( including age and available past medical history) Patient consent (before randomization), Video administration via headset(description below), Cast sawing, Physical examination (before and after procedure), Pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire procedure), NRS VAS pain administration (3 minutes pre-procedure and immediately post-procedure) in patients over 8 years(Will mark on scale), VAS Faces pain administration (3 minutes pre-procedure and immediately post-procedure)in patients under 8 years(Will point to face), NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-procedure)(Will mark on scale), VAS Faces anxiety administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years (Will point to face), Patient/parent satisfaction administration (post-procedure).

Group III: A treatment group that will be immersed in the VR game (Bear Blast) via the headset.Experimental Treatment1 Intervention

Demographic appropriate screening for inclusion ( including age and available past medical history) Patient consent (before randomization) VR assembly and administration (description below) Cast sawing, physical examination (before and after procedure) , pulse oximetry application (HR measured 3 minutes pre-procedure and throughout entire procedure), NRS VAS pain administration (3 minutes pre-procedure and immediately post-procedure) in patients over 8,-(Will mark on scale) VAS Faces pain administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years(Will point to face), NRS VAS anxiety administration (3 minutes pre-procedure and immediately post-procedure)(Will mark on scale), VAS Faces anxiety scale administration (3 minutes pre-procedure and immediately post-procedure) in patients under 8 years(Will point to face), Patient/parent satisfaction administration (post-procedure).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,138 Total Patients Enrolled

Peter D Fabricant, MD, MPHPrincipal InvestigatorHospital for Special Surgery, New York

Frequently Asked Questions

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

Is this investigation open to geriatric patients?

"According to the trial requirements, only 4-14 year olds are suitable candidates. Furthermore, there are 66 studies that target individuals under 18 and 287 for people over 65 years of age."

Answered by AI

Am I eligible to join this medical study?

"To be accepted into this trial, patients must have suffered a fracture or bone condition and are aged between 4 to 14 years old. At present, there is space for roughly 226 participants."

Answered by AI

What is the maximum capacity of participants for this research endeavor?

"Affirmative. According to information posted on clinicaltrials.gov, this experimental trial is still recruiting candidates and was initially announced on July 25th 2018 with the latest changes made August 18th 2022. It aims to enroll 226 participants from a single site."

Answered by AI

Are there remaining slots available to participants in this experiment?

"Affirmative. Clinicaltrials.gov shows that recruitment is presently underway for this trial, which was initially posted on July 25th 2018 and more recently updated on August 18th 2022. In total, 226 people are needed at 1 clinical centre to take part in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures

2018. "Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05510232.

All > Orthopedic