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

This study has been completed.
Sponsor:
Information provided by:
Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT00569647
First received: November 29, 2007
Last updated: December 6, 2007
Last verified: November 2007
History of Changes
  Purpose

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.


Condition Intervention
Anxiety
 Device: Virtual Reality Hypnosis
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Burns
U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • anxiety reduction [ Time Frame: preoperatively ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: November 2005
Study Completion Date: May 2006
Arms Assigned Interventions
Experimental: v
Use of VRH headset
 Device: Virtual Reality Hypnosis
Use of virtual reality headset to induce hypnotic state
Placebo Comparator: c Device: Placebo
no use of device

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.

  Eligibility

Ages Eligible for Study:   14 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child presenting for reconstructive burn surgery

Exclusion Criteria:

  • Visual or auditory difficulties
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569647

Sponsors and Collaborators
Shriners Hospitals for Children
Investigators
Principal Investigator: John E McCall, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: John E McCall MD PI, Shriners Hospital for Children
ClinicalTrials.gov Identifier: NCT00569647     History of Changes
Other Study ID Numbers: 277444040
Study First Received: November 29, 2007
Last Updated: December 6, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
preoperative anxiety
burn reconstruction

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013