NCT00569647

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Nov 2005

Shorter than P25 for not_applicable anxiety

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
Last Updated

December 7, 2007

Status Verified

November 1, 2007

First QC Date

November 29, 2007

Last Update Submit

December 6, 2007

Conditions

Anxiety

Keywords

preoperative anxietyburn reconstruction

Outcome Measures

Primary Outcomes (1)

  • anxiety reduction

    preoperatively

Study Arms (2)

v

EXPERIMENTAL

Use of VRH headset

Device: Virtual Reality Hypnosis

c

PLACEBO COMPARATOR
Device: Placebo

Interventions

Virtual Reality HypnosisDEVICE

Use of virtual reality headset to induce hypnotic state

v
PlaceboDEVICE

no use of device

c

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Child presenting for reconstructive burn surgery

You may not qualify if:

  • Visual or auditory difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • John E McCall, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2007

First Posted

December 7, 2007

Study Start

November 1, 2005

Study Completion

May 1, 2006

Last Updated

December 7, 2007

Record last verified: 2007-11