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

November 29, 2007
December 6, 2007
November 2005
Not Provided
anxiety reduction [ Time Frame: preoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00569647 on ClinicalTrials.gov Archive Site
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Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis
Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Anxiety
  • Device: Virtual Reality Hypnosis
    Use of virtual reality headset to induce hypnotic state
  • Device: Placebo
    no use of device
  • Experimental: v
    Use of VRH headset
    Intervention: Device: Virtual Reality Hypnosis
  • Placebo Comparator: c
    Intervention: Device: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
May 2006
Not Provided

Inclusion Criteria:

  • Child presenting for reconstructive burn surgery

Exclusion Criteria:

  • Visual or auditory difficulties
Both
14 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00569647
277444040
Yes
John E McCall MD PI, Shriners Hospital for Children
Shriners Hospitals for Children
Not Provided
Principal Investigator: John E McCall, MD University of Cincinnati
Shriners Hospitals for Children
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP