Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures

NCT05510232 | Completed Results

• 1 other identifier: 2018-0074
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

Virtual Reality(VR) has had promising applications in science and medicine, including intervention delivery. The use of VR interventions has been studied in a wide range of medical conditions, including anxiety, phobias, obesity, chronic pain, and eating disorders. VR based simulation in pediatrics has grown rapidly in recent years and is expected to continue to grow. VR technology has become increasingly affordable, flexible, and portable, enabling its use in a broad range of environments including the outpatient clinical setting. Additionally, children are believed to have an inclination toward games of "pretend" or alternate realities further indicating the potential of this technology. While immersed in a game, they often become deeply absorbed and able to ignore aversive stimuli. VR is an engaging intervention that may help to detract from pain and anxiety for children undergoing painful procedures. Heart rate has been used as a means to objectively quantify the physiologic response to pain and anxiety. The purpose of the study is to conduct a randomized controlled study that assess the utility of Virtual Reality simulations compared to non immersive visual distraction in pediatric patients undergoing outpatient procedures including cast removal and surgical suture/pins removal. Primary outcomes will include changes in patient heart rate (an age-validated surrogate for pain and anxiety) and patient-reported changes in anxiety and pain. Secondary outcomes will include patient/parent-reported satisfaction.

Conditions

Fractures, Bone; Deformity; Bone

Outcome Measures

Primary Outcomes (1)

• Absolute Difference in HR as Measured 3 Minutes Prior to Procedure and Maximum as Measured During Through 1 Minute After Procedure.

  Pulse oximetry application

  3 minutes pre-procedure until 1 minute post-procedure, up to 20 minutes

Secondary Outcomes (3)

• Difference in Visual Analogue Scale (VAS) Pain Score as Measured 3 Minutes Before and Immediately After Intervention

  3 minutes before and immediately after intervention

• Difference in Visual Analogue Scale (VAS) Anxiety Score as Measured 3 Minutes Before and Immediately After Intervention

  3 minutes before and immediately after intervention

• Parent/Guardian Post-procedure Satisfaction Questionnaire Response

  Immediately after intervention

Study Arms (3)

A treatment group that will watch a non-VR video via an iPad

EXPERIMENTAL

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).

Device: A treatment group that will watch a non-VR video via an iPad

A treatment group that will have headset on and will watch a VR video

EXPERIMENTAL

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).

Device: A treatment group that will have headset on and will watch a non-VR video

A treatment group that will be immersed in the VR game (Bear Blast) via the headset.

EXPERIMENTAL

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).

Device: A treatment group that will be immersed in the VR game (Bear Blast) via the headset.

Interventions

A treatment group that will watch a non-VR video via an iPad DEVICE

The iPad is a tablet computer first offered by Apple in 2010.The device resembles a much larger version of Apple's iPhone or its iPod Touch, and is about the same size as a magazine.The iPad uses the same operating system as the Apple iPhone, and uses very similar hardware. iPad will be used to deliver non VR video to patients. A standardized age appropriate video will be used for patients between ages 4-9 and a different standardized age appropriate video for patients ages 10-14. The selected videos will be the same for both the cast and suture/pin removal groups.

A treatment group that will watch a non-VR video via an iPad

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

Oculus headset will deliver VR video to patients. Headset will be administered before intervention and removed at the completion of the intervention unless patient requests otherwise. Patients visual field will not change with head motion and will remain static throughout cast removal or pin/suture removal. A standardized age appropriate video will be used for patients between ages 4-14. The selected videos will be the same for both the cast and suture/pin removal groups.

A treatment group that will have headset on and will watch a VR video

A treatment group that will be immersed in the VR game (Bear Blast) via the headset. DEVICE

VR using the Oculus headset will deliver VR images and sound. Patients will watch a 15-minute VR experience called Bear Blast. Bear Blast is an immersive, 360-degree, game experience that takes place in a fantasy world where the user attempts to shoot balls at a wide range of moving objects by gently maneuvering his or her head toward the targets. Bear Blast is a nonviolent and noncompetitive game that incorporates motivational music and features positively reinforcing sounds, animation, and direct messages to patients. Bear Blast will be used as the standardized game for all patients in the VR group of both study arms. The VR Oculus headset can be controlled entirely via head motion and does not involve the use of patients extremities.

A treatment group that will be immersed in the VR game (Bear Blast) via the headset.

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients pediatric patients undergoing cast, pin and suture removal between the ages of 4 -14 years

You may not qualify if:

• History of epilepsy and seizures
• Anxiety disorders documented
• Unable to understand/follow VR directions
• History of vertigo and/or dizziness
• History of chronic pain
• Non-English speakers

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Wounds and Injuries; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Peter Fabricant
• Organization: Hospital for Special Surgery

fabricantstaff@hss.edu

(212) 606-1996

Study Officials

• Peter D Fabricant, MD, MPH

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized to each arm, with a target of 35 subjects in each arm.

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: July 25, 2018
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: January 31, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-01

Locations

US (1)