Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000991516
Ethics application status
Approved
Date submitted
30/08/2015
Date registered
22/09/2015
Date last updated
22/12/2021
Date data sharing statement initially provided
16/05/2019
Date results information initially provided
22/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Hypnosis for Acute Burn Pain
Scientific title
Burns Patient use of Hypnosis for Pain Experience
Secondary ID [1] 287366 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn pain 296041 0
Condition category
Condition code
Alternative and Complementary Medicine 296311 296311 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hypnosis Recording: The recording is approximately 25 minutes long and is based on a technique called Rapid Induction Analgesia (RIA), first proposed by Barber (1977). The script uses several hypnotic techniques to create a state of deep relaxation and receptivity, making the patient open to suggestions about their pain experience. Participants will listen to the recording 5 times and then they will listen to it again during their next dressing change. Patients will have 2-4 days to listen to the recordings and will listen to them once or twice each day, according to their choice and the time they have available. The procedure will take between 30 and 90 minutes depending on the nature of the burn injury. A nurse will assist participants to schedule listening to the recording.
Intervention code [1] 292708 0
Treatment: Other
Comparator / control treatment
The study will use one control condition. this will be a "treatment as usual" condition where the participant will receive usual care during dressing changes.

Measurements will also be taken during one dressing change prior to any intervention/control condition, to act as a baseline measure for all participants.
Control group
Active

Outcomes
Primary outcome [1] 295964 0
Pain Intensity
Assessed using Visual Analogue Scales and the McGill Pain Questionnaire
Timepoint [1] 295964 0
Immediately after the dressing change
Primary outcome [2] 295965 0
Anxiety assessed by Visual Analogue Scales and the Burn Pain Specific Anxiety Index
Timepoint [2] 295965 0
Immediately after the dressing change
Secondary outcome [1] 317066 0
Medication consumption
Assessed by review of hospital records
Timepoint [1] 317066 0
From start of procedure until 2 hours post end of procedure

Eligibility
Key inclusion criteria
Adult - over 18
Burn injury that requires surgery
1-20% TBSA
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intellectual disability
Psychotic disorders
Extreme emotional distress
Deafness
Muteness
Substance use withdrawal
Non-English speaking

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Results will be analysed using repeated measures ANOVA to investigate the efficacy of the hypnosis recording.

Sample size was calculated using a G Power program, with power set at 0.8, p-value of 0.05 and effect size at 0.2.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2016
Actual
1/01/2016
Date of last participant enrolment
Anticipated
31/08/2019
Actual
30/06/2019
Date of last data collection
Anticipated
31/08/2019
Actual
30/06/2019
Sample size
Target
82
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4271 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 10217 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 291926 0
University
Name [1] 291926 0
Murdoch University
Country [1] 291926 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Fiona Wood Foundation
Address
Fiona Stanley Hospital
Level 4, Burns Outpatient Clinic
11 Warren Smith Drive
Murdoch 6150 WA
Country
Australia
Secondary sponsor category [1] 290591 0
Hospital
Name [1] 290591 0
Fiona Stanley Hospital
Address [1] 290591 0
11 Warren Smith Drive
Murdoch 6150 WA
Country [1] 290591 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293430 0
WA Department of Health Human Research Ethics Committee
Ethics committee address [1] 293430 0
Harry Perkins Institute
11 Warren Smith Drive
Murdoch 6150 WA
Ethics committee country [1] 293430 0
Australia
Date submitted for ethics approval [1] 293430 0
04/09/2015
Approval date [1] 293430 0
28/10/2015
Ethics approval number [1] 293430 0
15-140

Summary
Brief summary
Burn injuries and treatment often cause excruciating pain for patients. Hypnosis has demonstrated benefits in treating pain in addition to pharmacological pain management. However, psychological pain management techniques are not currently used in standard pain management protocols on burns units.

Audio recordings could be an efficient way for patients to access these treatments, and nurses may be well-positioned to assist patients to use them, as they spend more time with the patient than other clinicians and are usually present during wound dressing changes.

The aims of this project are:

1. To explore the feasibility of using audio recordings of hypnosis as an adjunct to pharmacological treatment of burn pain.
2. To explore the feasibility of nurses assisting with the administration of hypnosis recordings.

Adults over 18 years of age who are admitted to the burns unit with an injury that requires surgery will be screened and those who are eligible will be invited to participate in the study.

Pain, anxiety and relaxation will be measured for all participants during a dressing change to give baseline information. Then patients in an experimental group will be asked to listen to a 25 minute recording of hypnosis 5 times to practice before using the recording in a further dressing change. Those in a control group will receive standard care during their dressing changes. After dressing changes patients will be asked to rate their pain, anxiety and relaxation experience. Nurses will administer the recordings.

The experiment will follow a repeated-measures between groups design, which means that pain, anxiety and relaxation ratings and personality measures can be compared between the groups before and after treatment.

Results will provide information about the benefits of hypnosis and mindfulness audio recordings for patients on the burns unit, and the feasibility of using nurses to administer these. They will also provide valuable information about personality variables that influence how well someone will benefit from either treatment, which will assist with treatment planning.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59890 0
Ms Kathryn James
Address 59890 0
School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch 6150 WA
Country 59890 0
Australia
Phone 59890 0
+61 8 458620032
Fax 59890 0
Email 59890 0
[email protected]
Contact person for public queries
Name 59891 0
Ms Kathryn James
Address 59891 0
School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch 6150 WA
Country 59891 0
Australia
Phone 59891 0
+ 61 8 458620032
Fax 59891 0
Email 59891 0
[email protected]
Contact person for scientific queries
Name 59892 0
Ms Kathryn James
Address 59892 0
School of Psychology and Exercise Science
Murdoch University
90 South Street
Murdoch 6150 WA
Country 59892 0
Australia
Phone 59892 0
+61 8 458620032
Fax 59892 0
Email 59892 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All patient and nurse pain and anxiety ratings, TAS-BF scores and demographic data can be shared.
When will data be available (start and end dates)?
From 20/08/2021 until 5 years after publication
Available to whom?
Qualified researchers
Available for what types of analyses?
Researchers will need to contact the lead researcher to determine suitability
How or where can data be obtained?
This study involved collection of data from human participants. Before the data set is shared, each participant will provide their written informed consent for data sharing to occur. An offer to share data collected from consenting participants with qualified researchers will be included in publications arising from this project.

Contact Kate James - [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 369208-(Uploaded-24-11-2021-17-51-16)-Basic results summary.docx
Plain language summaryNo The results generally supported the prediction tha... [More Details]

Documents added automatically
No additional documents have been identified.