Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis - Full Text View

Sponsored by:	Shriners Hospitals for Children
Information provided by:	Shriners Hospitals for Children
ClinicalTrials.gov Identifier:	NCT00569647

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

MedlinePlus related topics: Anxiety Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis

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
v: Experimental Use of VRH headset	Device: Virtual Reality Hypnosis Use of virtual reality headset to induce hypnotic state
c: Placebo Comparator	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

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

Keywords provided by Shriners Hospitals for Children:

preoperative anxiety
burn reconstruction

Study placed in the following topic categories:

Burns

ClinicalTrials.gov processed this record on January 15, 2009