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Sponsored by: |
Shriners Hospitals for Children |
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Information provided by: | Shriners Hospitals for Children |
ClinicalTrials.gov Identifier: | NCT00569647 |
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 |
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Anxiety |
Device: Virtual Reality Hypnosis Device: Placebo |
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 |
Enrollment: | 25 |
Study Start Date: | November 2005 |
Study Completion Date: | May 2006 |
Arms | Assigned Interventions |
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v: Experimental
Use of VRH headset
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Device: Virtual Reality Hypnosis
Use of virtual reality headset to induce hypnotic state
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c: Placebo Comparator |
Device: Placebo
no use of device
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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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
preoperative anxiety burn reconstruction |
Burns |