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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00569647
First Posted: December 7, 2007
Last Update Posted: December 7, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shriners Hospitals for Children
November 29, 2007
December 7, 2007
December 7, 2007
November 2005
Not Provided
anxiety reduction [ Time Frame: preoperatively ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Intervention Model: Single Group Assignment
Masking: None (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
Sexes Eligible for Study: All
14 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00569647
277444040
Yes
Not Provided
Not Provided
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