Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614001034628
Ethics application status
Approved
Date submitted
16/09/2014
Date registered
25/09/2014
Date last updated
14/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Rapid Induction Analgesia: Audio recordings of hypnosis for induced pain in a student sample
Scientific title
Effect of rapid induction analgesia by hypnosis recording compared to relaxing music on pain intensity and distress associated with acute pain in a sample of university students
Secondary ID [1] 285332 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Pain 293058 0
Condition category
Condition code
Anaesthesiology 293335 293335 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Rapid Induction Analgesia is a 20-minute hypnosis procedure with suggestions for relaxation and pain mediation. The intervention will be given as an audio recording that lasts for 20 minutes. There will be two experimental conditions, one where participants listen to the recording two days, then one day before and during a testing session and one where they just listen during the testing session. In the testing session pain will be induced using capsaicin applied to their forearms. Participants will then listen to the recording, or relaxing music, and then rate pain distress and intensity in response to several mechanical stimuli applied to the forearm. Mechanical stimulation will be applied using an algometer which measures pressure, a temperature simulator that will apply heat of approximately 43C and a Neuropen that will produce a sharp pricking sensation. The testing session will take approximately one hour.
Intervention code [1] 290244 0
Treatment: Other
Comparator / control treatment
The control group will listen to relaxing music for 20 minutes after capsaicin has been applied and before rating pain distress and intensity in response to mechanical stimulation.
Control group
Active

Outcomes
Primary outcome [1] 293161 0
Pain intensity associated with physical stimuli on capsaicin application site in experimental group versus control group as assessed on a scale of 1-10.
Timepoint [1] 293161 0
Before capsaicin application and 30 minutes after capsaicin application
Primary outcome [2] 293162 0
Psychological distress associated with physical stimuli on capsaicin application site in experimental group versus control group as assessed on a scale of 1-10.
Timepoint [2] 293162 0
Before capsaicin application and 30 minutes after capsaicin application
Secondary outcome [1] 310529 0
Sharpness, using a neuropen applied to the forearm, with participant ratings of sharpness on a 1-10 scale
Timepoint [1] 310529 0
Before capsaicin application and 30 minutes after capsaicin application
Secondary outcome [2] 310561 0
Pressure pain threshold will be measured using an algometer
Timepoint [2] 310561 0
Before capsaicin application and 30 minutes after capsaicin application
Secondary outcome [3] 310562 0
Heat intensity will be assessed using a thermal simulator applied to the forearm. Participants will rate heat intensity on a scale from 1-10
Timepoint [3] 310562 0
Before capsaicin application and 30 minutes after capsaicin application

Eligibility
Key inclusion criteria
Adults 18 and over
Generally good physical and mental health
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosis of a dissociative disorder, major depression, any anxiety condition with severe anxiety symptoms, schizophrenia
Diagnosis of a chronic pain condition
Pregnancy
Breastfeeding
Identified allergy to chilli or capsaicin

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)
Participants will be recruited through poster advertisements placed on notice boards throughout the campus. The student researcher will attend psychology lectures as approved to personally recruit participants, and hand out poster advertisements. Poster advertisements will outline the process for signing up for the study, which will involve an email or telephone call to the student researcher and/or signing up to the Murdoch Psychology Subject Pool website.

Willing participants will contact the researcher and go through a brief screening interview to rule out exclusion criteria. They will then be randomly allocated to the experimental or control condition. Allocation will not be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In a similar study using hypnosis for pain management (Wright and Drummond, 2001), 58 participants were recruited for three conditions (attention control, assessment during rapid induction analgesia, assessment after rapid induction analgesia). As this sample size (approximately 20 per condition) was sufficient to identify significant effects of rapid induction analgesia in that study (indicating a large effect size), we will also recruit approximately 20 subjects in each condition in the present study.

Differences in the mean values of several measures of the three groups on several measures of pain experience will be compared using analysis of variance.


Wright, B. & Drummond, P. (2001). The effect of rapid induction analgesia on subjective pain ratings and pain tolerance. International Journal of Clinical and Experimental Hypnosis. 49:2. 109-122

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/10/2014
Actual
10/01/2015
Date of last participant enrolment
Anticipated
30/06/2015
Actual
30/04/2015
Date of last data collection
Anticipated
Actual
30/04/2015
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 8696 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 289960 0
Self funded/Unfunded
Name [1] 289960 0
Country [1] 289960 0
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 288651 0
None
Name [1] 288651 0
Address [1] 288651 0
Country [1] 288651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291666 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 291666 0
Ethics committee country [1] 291666 0
Australia
Date submitted for ethics approval [1] 291666 0
Approval date [1] 291666 0
22/08/2014
Ethics approval number [1] 291666 0
2014/164

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51426 0
Prof Peter Drummond
Address 51426 0
Social Sciences Building room 1.020
Murdoch University
90 South Street
Murdoch WA 6150
Country 51426 0
Australia
Phone 51426 0
+61 8 9360 2415
Fax 51426 0
Email 51426 0
[email protected]
Contact person for public queries
Name 51427 0
Kathryn James
Address 51427 0
Social Sciences Building room 1.020
Murdoch University
90 South Street
Murdoch WA 6150
Country 51427 0
Australia
Phone 51427 0
+61 458620032
Fax 51427 0
Email 51427 0
[email protected]
Contact person for scientific queries
Name 51428 0
Peter Drummond
Address 51428 0
Social Sciences Building room 1.020
Murdoch University
90 South Street
Murdoch WA 6150
Country 51428 0
Australia
Phone 51428 0
+61 8 9360 2415
Fax 51428 0
Email 51428 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.