A Study of the Effectiveness of Virtual Reality Relaxation Combined With Patient-Controlled Analgesia (PCA) Morphine for Those Undergoing Burn Dressing Changes

This study is currently recruiting participants.

Verified by Bayside Health, September 2005

First Received: September 12, 2005 Last Updated: March 14, 2007 History of Changes

Sponsored by:	Bayside Health
Information provided by:	Bayside Health
ClinicalTrials.gov Identifier:	NCT00163917

Purpose

The purpose of this study is to evaluate whether a sub-population of patients with burn injuries needing dressing changes respond to virtual reality (VR) utilising relaxation themes with improved pain and anxiety scores, when added to PCA morphine and background analgesic therapy.

Condition	Intervention
Anxiety Pain	Device: Virtual reality relaxation

MedlinePlus related topics: Anxiety Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Predicting the Effectiveness of Virtual Reality Relaxation on Pain and Anxiety When Added to PCA Morphine in a Population of Burn Patients Having Dressing Changes

Further study details as provided by Bayside Health:

Primary Outcome Measures:

Association between hypnotic susceptibility and pain scores
Association between hypnotic susceptibility and anxiety scores

Secondary Outcome Measures:

Measurement of pain by visual analogue scale (VAS)
Measurement of anxiety by Burns Specific Anxiety Rating by VAS
Rating of hypnotic susceptibility and morphine use
Satisfaction rating
Morphine use
Incidence of side effects relating to morphine and VR

Estimated Enrollment:	90
Study Start Date:	September 2004

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Burn injury
Scheduled for painful dressing changes
Conscious
Comprehension of PCA and virtual reality device
Comprehension of the English language

Exclusion Criteria:

Patient refusal
Psychotic disease
Paranoid disease
Unstable dissociative disorder
Borderline personality disorder
Phobias relevant to water/drowning
Epilepsy/propensity to fitting
Morphine allergy
Acute brain syndrome
Chronic brain syndrome
Physically unable to administer PCA
Severe burns involving the head
Visual impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163917

Contacts

Contact: Alex Konstantatos, MBBS, FANZCA	03 92763176 ext 3757	a.konstantatos@alfred.org.au
Contact: Margaret E Angliss, BN	03 92763176 ext 3757	m.angliss@alfred.org.au

Locations

Australia, Victoria
The Alfred Hospital	Recruiting
Melbourne, Victoria, Australia, 3181
Contact: Alex Konstantatos, MBBS 03 92763176 ext 3757 a.konstantatos@alfred.org.au
Principal Investigator: Alex Konstantatos, MBBS

Sponsors and Collaborators

Bayside Health

Investigators

Principal Investigator:

Alex Konstantatos, MBBS

The Alfred Hospital

More Information

No publications provided

Study ID Numbers:	107/ 04
Study First Received:	September 12, 2005
Last Updated:	March 14, 2007
ClinicalTrials.gov Identifier:	NCT00163917 History of Changes
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by Bayside Health:

Hypnosis
Analgesia

Study placed in the following topic categories:

Burns
Morphine
Pain

ClinicalTrials.gov processed this record on May 06, 2009