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

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ClinicalTrials.gov Identifier: NCT00569647
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : December 7, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Anxiety Device: Virtual Reality Hypnosis Device: Placebo

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis
Study Start Date : November 2005
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. anxiety reduction [ Time Frame: preoperatively ]

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Child presenting for reconstructive burn surgery

Exclusion Criteria:

  • Visual or auditory difficulties
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569647


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

Responsible Party: John E McCall MD PI, Shriners Hospital for Children
ClinicalTrials.gov Identifier: NCT00569647     History of Changes
Other Study ID Numbers: 277444040
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: December 7, 2007
Last Verified: November 2007

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders