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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
a.konstantatos@alfred.org.au
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00163917