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

N/A
Waitlist Available
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
No Placebo-Only Group

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
  • Malalignment
  • Broken Bones
  • Bone Deformity

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Absolute difference in HR as measured 3 minutes prior to procedure and maximum as measured during through 1 minute after procedure.
Secondary study objectives
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

Awards & 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: 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).

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
250 Previous Clinical Trials
61,110 Total Patients Enrolled
Peter D Fabricant, MD, MPHPrincipal InvestigatorHospital for Special Surgery, New York
~31 spots leftby Nov 2025
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