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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 because the information has not been verified recently.
Verified September 2005 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00163917
First received: September 12, 2005
Last updated: March 14, 2007
Last verified: September 2005
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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:

MedlinePlus related topics: Anxiety Burns
U.S. FDA Resources

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

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

Keywords provided by Bayside Health:
Hypnosis
Analgesia

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013