Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Device: Virtual Reality Hypnosis; Device: Placebo

• Registration Number: NCT00569647
• Lead Sponsor: Shriners Hospitals for Children

Brief Summary

Children with burns often require repeated reconstructive surgeries. These children tend to develop high levels of anxiety before coming to the operating room. Preoperative sedation, while somewhat effective in relieving this anxiety, has a number of side effects. The researchers hypothesized that preoperative anxiety could be effectively reduced by the utilization of a device which induces a relaxing hypnotic state through emmersion in a virtual reality environment.

Detailed Description

The virtual reality environment is created by a Virtual Reality Hypnosis (VRH) device. The patient wears a headset which contains video and audio display. A twenty minute program is viewed, which guides the patient into a relaxed state via soothing audio and video input.

Study Timeline

• Study Start: 2005-11
• Study Completion: 2006-05
• Status Verified: 2007-11
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-12-06
• Last Update Submitted: 2007-12-06
• Study First Posted: 2007-12-07
• Last Update Posted: 2007-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Child presenting for reconstructive burn surgery

Exclusion Criteria

• Visual or auditory difficulties

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
v	Virtual Reality Hypnosis	Use of VRH headset
c	Placebo	-

Primary Outcome Measures

Name	Time	Method
anxiety reduction	preoperatively