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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Bayside Health.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163917
First Posted: September 14, 2005
Last Update Posted: March 15, 2007
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.
Information provided by:
Bayside Health
  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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
  More Information

ClinicalTrials.gov Identifier: NCT00163917     History of Changes
Other Study ID Numbers: 107/ 04
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: March 15, 2007
Last Verified: September 2005

Keywords provided by Bayside Health:
Hypnosis
Analgesia

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