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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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Bayside Health

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date March 15, 2007
Study Start Date  ICMJE September 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2007)
  • Association between hypnotic susceptibility and pain scores
  • Association between hypnotic susceptibility and anxiety scores
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 1)Association between hypnotic susceptibilty and pain scores
  • 2.Association between hypnotic susceptibility and anxiety scores
Change History Complete list of historical versions of study NCT00163917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effectiveness of Virtual Reality Relaxation Combined With Patient-Controlled Analgesia (PCA) Morphine for Those Undergoing Burn Dressing Changes
Official Title  ICMJE 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
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.
Detailed Description

Pain associated with burn dressing changes does not arise purely from a physical source; it is also commonly influenced by psychological factors. The anticipation that accompanies a dressing change has the potential to set up fear and heightened anxiety as the patient is aware that at a predetermined time other people will manipulate injured areas on his/her body.

Many techniques of analgesia have been advocated in burn dressing changes. Opiates have been the mainstay, and many techniques for their administration have been described. In particular the use of background plus PCA administration of opiates has been demonstrated to be superior to PCA administration alone. Another analgesic/dissociative agent commonly described for these procedures is Ketamine. Both opiates and ketamine have limitations in that they cause unfavourable side effects such as respiratory depression, sedation and nausea and vomiting in the case of opiates and respiratory depression, hallucinations and unpleasant dreams in the case of ketamine. Other problems relating to the use of opiates and ketamine relate to the approach of treating a multifaceted experience such as burn dressing pain solely with pharmacotherapy.

The need for psychological interventions in burn dressings has been highlighted by many researchers. In particular, Ptacek noted that burn patients experiencing more anxiety tended to have higher ratings of pain, while those with larger areas of burns reported more affective pain and greater variability in pain ratings.

There is strong consistency among reviewers for recommending the addition of adjunctive therapies of a psychological nature for managing patients having burn dressing changes. Patterson et.al in particular is of the belief that burn patients having dressing changes are more amenable to hypnotherapy as an analgesic adjunct.

The nature of psychological interventions examined by researchers have included hypnosis (where strong suggestions were aimed at reducing tension, anxiety, and sensation of pain), rapid induction analgesia, simple stress reducing strategies, attention and information, and autohypnosis. While some have conducted prospective trials which involve large numbers of patients, only one trial actually made mention of randomizing participants. Most other reports examining psychological therapies have been at the case report level.

While most of these trials and case reports have reported favourable outcomes, no single trial has been able to consistently show a significant reduction of pain scores and anxiety ratings and analgesic consumption.

Virtual Reality (VR) assisted techniques that modify psychological well-being are beginning to play a role in clinical practise and in research. There are currently two publications, one a case report and another a prospective randomized trial which specifically examine the role of VR in the context of painful procedures associated with burn injuries. The randomized crossover trial by Hoffman et.al in 6 patients having physical therapy utilising immersive VR found a significant reduction in pain ratings in all patients, while Patterson et.al described the successful use of VR hypnosis in one “difficult” patient which had lasting effects for up to 48 hours.

Reviews of psychological therapies for patients having burn dressing changes have addressed the need for more systematic controlled trials to supplement existing evidence and more clearly define the role of such interventions. Coupled with this is the need for more knowledge as to the most appropriate psychological intervention and the ideal situations where it will prove most beneficial. Patterson feels that there is good anecdotal evidence that burn patients have a particular propensity to respond to adjunctive therapies incorporating hypnosis. Hypnosis screening among burn patients involving the hypnotic induction profile demonstrated a link between high hypnotizability and the experience of more intense arousal, greater avoidance and more significant feelings of intrusiveness.

We propose to conduct a prospective randomized trial which looks at the effect that VR relaxation has when combined with PCA morphine in a group of patients having potentially painful dressing changes. In addition we want to isolate patients who have high susceptability to hypnosis and compare their ratings of pain, anxiety and opiate requirement with patients of lesser susceptibility. Our hypothesis is that patients with higher susceptibility to hypnosis stand to gain most from the addition of VR to their pharmacotherapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety
  • Pain
Intervention  ICMJE Device: Virtual reality relaxation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 12, 2005)
90
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00163917
Other Study ID Numbers  ICMJE 107/ 04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Bayside Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alex Konstantatos, MBBS The Alfred
PRS Account Bayside Health
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP