Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00163917




Registration number
NCT00163917
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
15/03/2007

Titles & IDs
Public title
A Study of the Effectiveness of Virtual Reality Relaxation Combined With Patient-Controlled Analgesia (PCA) Morphine for Those Undergoing Burn Dressing Changes
Scientific 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
Secondary ID [1] 0 0
107/ 04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 0 0
Pain 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Virtual reality relaxation

Treatment: Devices: Virtual reality relaxation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Association between hypnotic susceptibility and pain scores
Timepoint [1] 0 0
Primary outcome [2] 0 0
Association between hypnotic susceptibility and anxiety scores
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Measurement of pain by visual analogue scale (VAS)
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Measurement of anxiety by Burns Specific Anxiety Rating by VAS
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Rating of hypnotic susceptibility and morphine use
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Satisfaction rating
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Morphine use
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Incidence of side effects relating to morphine and VR
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
- Burn injury

- Scheduled for painful dressing changes

- Conscious

- Comprehension of PCA and virtual reality device

- Comprehension of the English language
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00163917
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alex Konstantatos, MBBS
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alex Konstantatos, MBBS, FANZCA
Address 0 0
Country 0 0
Phone 0 0
03 92763176
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00163917