ANZCTR - Registration

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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 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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Burn pain

Condition category

Condition code

Alternative and Complementary Medicine

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]

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]

Pain Intensity Assessed using Visual Analogue Scales and the McGill Pain Questionnaire

Timepoint [1]

Immediately after the dressing change

Primary outcome [2]

Anxiety assessed by Visual Analogue Scales and the Burn Pain Specific Anxiety Index

Timepoint [2]

Immediately after the dressing change

Secondary outcome [1]

Medication consumption Assessed by review of hospital records

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment postcode(s) [1]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

University

Name [1]

Murdoch University

Address [1]

90 South Street Murdoch 6150 WA

Country [1]

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]

Hospital

Name [1]

Fiona Stanley Hospital

Address [1]

11 Warren Smith Drive Murdoch 6150 WA

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

WA Department of Health Human Research Ethics Committee

Ethics committee address [1]

Harry Perkins Institute
11 Warren Smith Drive
Murdoch 6150 WA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

04/09/2015

Approval date [1]

28/10/2015

Ethics approval number [1]

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

Ms Kathryn James

Address

School of Psychology and Exercise Science Murdoch University 90 South Street Murdoch 6150 WA

Country

Australia

Phone

+61 8 458620032

Fax

[email protected]

Contact person for public queries

Name

Kathryn James

Address

School of Psychology and Exercise Science Murdoch University 90 South Street Murdoch 6150 WA

Country

Australia

Phone

+ 61 8 458620032

Fax

[email protected]

Contact person for scientific queries

Name

Kathryn James

Address

School of Psychology and Exercise Science Murdoch University 90 South Street Murdoch 6150 WA

Country

Australia

Phone

+61 8 458620032

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Qualified researchers

Conditions for requesting access:
• -

What individual participant data might be shared?

• All patient and nurse pain and anxiety ratings, TAS-BF scores and demographic data can be shared.

What types of analyses could be done with individual participant data?

• Researchers will need to contact the lead researcher to determine suitability

When can requests for individual participant data be made (start and end dates)?

From:
From 20/08/2021 until 5 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• 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]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically