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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00163917
Recruitment Status : Unknown
Verified September 2005 by Bayside Health.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : March 15, 2007
Information provided by:
Bayside Health

Brief Summary:
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 or disease Intervention/treatment Phase
Anxiety Pain Device: Virtual reality relaxation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Burns

Primary Outcome Measures :
  1. Association between hypnotic susceptibility and pain scores
  2. Association between hypnotic susceptibility and anxiety scores

Secondary Outcome Measures :
  1. Measurement of pain by visual analogue scale (VAS)
  2. Measurement of anxiety by Burns Specific Anxiety Rating by VAS
  3. Rating of hypnotic susceptibility and morphine use
  4. Satisfaction rating
  5. Morphine use
  6. Incidence of side effects relating to morphine and VR

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00163917

Contact: Alex Konstantatos, MBBS, FANZCA 03 92763176 ext 3757
Contact: Margaret E Angliss, BN 03 92763176 ext 3757

Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3181
Contact: Alex Konstantatos, MBBS    03 92763176 ext 3757   
Principal Investigator: Alex Konstantatos, MBBS         
Sponsors and Collaborators
Bayside Health
Principal Investigator: Alex Konstantatos, MBBS The Alfred Identifier: NCT00163917     History of Changes
Other Study ID Numbers: 107/ 04
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: March 15, 2007
Last Verified: September 2005

Keywords provided by Bayside Health:

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents