MedDataX Logo

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

NCT ID: NCT00569647

Last Updated: 2007-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

preoperative anxiety burn reconstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

v

Use of VRH headset

Group Type EXPERIMENTAL

Virtual Reality Hypnosis

Intervention Type DEVICE

Use of virtual reality headset to induce hypnotic state

c

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

no use of device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual Reality Hypnosis

Use of virtual reality headset to induce hypnotic state

Intervention Type DEVICE

Placebo

no use of device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Child presenting for reconstructive burn surgery

Exclusion Criteria

* Visual or auditory difficulties
Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shriners Hospitals for Children

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shriners Hospital for Children

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John E McCall, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

277444040

Identifier Type: -

Identifier Source: org_study_id