Back to resultsPreoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality Hypnosis
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety focused on measuring preoperative anxiety, burn reconstruction
Eligibility Criteria
Inclusion Criteria:
- Child presenting for reconstructive burn surgery
Exclusion Criteria:
- Visual or auditory difficulties
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
v
c
Arm Description
Use of VRH headset
Outcomes
Primary Outcome Measures
anxiety reduction
Secondary Outcome Measures
Full Information
NCT ID
NCT00569647
First Posted
November 29, 2007
Last Updated
December 6, 2007
Sponsor
Shriners Hospitals for Children
1. Study Identification
Unique Protocol Identification Number
NCT00569647
Brief Title
Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis
Official Title
Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shriners Hospitals for Children
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
preoperative anxiety, burn reconstruction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
v
Arm Type
Experimental
Arm Description
Use of VRH headset
Arm Title
c
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Virtual Reality Hypnosis
Intervention Description
Use of virtual reality headset to induce hypnotic state
Intervention Type
Device
Intervention Name(s)
Placebo
Intervention Description
no use of device
Primary Outcome Measure Information:
Title
anxiety reduction
Time Frame
preoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Child presenting for reconstructive burn surgery
Exclusion Criteria:
Visual or auditory difficulties
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John E McCall, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Preoperative Anxiety in Pediatric Reconstructive Burn Patients: The Role of Virtual Reality Hypnosis
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