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

This study has been completed.
Information provided by:
Shriners Hospitals for Children Identifier:
First received: November 29, 2007
Last updated: December 6, 2007
Last verified: November 2007
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
Device: Virtual Reality Hypnosis
Device: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
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:

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • anxiety reduction [ Time Frame: preoperatively ]

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.

Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Child presenting for reconstructive burn surgery

Exclusion Criteria:

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

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

Responsible Party: John E McCall MD PI, Shriners Hospital for Children Identifier: NCT00569647     History of Changes
Other Study ID Numbers: 277444040
Study First Received: November 29, 2007
Last Updated: December 6, 2007

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders processed this record on May 25, 2017