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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Acute Pain

Condition category

Condition code

Anaesthesiology

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]

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]

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]

Before capsaicin application and 30 minutes after capsaicin application

Primary outcome [2]

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]

Before capsaicin application and 30 minutes after capsaicin application

Secondary outcome [1]

Sharpness, using a neuropen applied to the forearm, with participant ratings of sharpness on a 1-10 scale

Timepoint [1]

Before capsaicin application and 30 minutes after capsaicin application

Secondary outcome [2]

Pressure pain threshold will be measured using an algometer

Timepoint [2]

Before capsaicin application and 30 minutes after capsaicin application

Secondary outcome [3]

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]

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]

6150 - Murdoch

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

University

Name

Murdoch University

Address

90 South Street
Murdoch WA 6150

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Murdoch University Human Research Ethics Committee

Ethics committee address [1]

Chancellery Building
South Street
MURDOCH WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/08/2014

Ethics approval number [1]

2014/164

Summary

Brief summary

A Variety of research suggests that hypnosis can be used successfully to treat acute pain (Patterson and Jensen, 2003; Wright and Drummond, 2001). Specifically, it has been demonstrated that hypnosis can reduce the intensity of pain experienced by patients with burn injuries during treatment (Wright and Drummond, 2000). Hypnosis also appears to have unique effects above and beyond other pain management treatments, such as opioid analgesics and relaxation training (Patterson, 2010). 

Despite this, it appears that hospitals do not routinely use hypnosis or other psychological pain management strategies with their patients. One reason for this may be that hospitals are not well resourced with clinical psychology staff, and thus their time is taken up with high priority issues such as post trauma psychological symptoms. Another reason may be a lack of education amongst medical staff of the benefits of hypnosis for pain management. 

It has been suggested that nurses are well positioned within a hospital environment to use hypnosis for pain management (Valente, 2006). Nurses spend more time with patients than other clinicians, and are often present during painful procedures. However, nurses have a demanding role and may not have time amongst their general duties, or specialist training, to work through hypnosis protocols with patients. It has been suggested that nurses may have time to administer and reinforce an audio recording of a hypnosis protocol, and that this may have similar benefits to protocols administered directly by a practitioner. 

The aim of this study is to trial an audio recording of a Rapid Induction Analgesia (RIA) hypnosis protocol with a student sample, as a pilot study, to determine if a larger scale study at the burns unit at Fiona Stanley hospital may be worthwhile in 2015. The effects of hypnosis on students’ experience of pain will be examined.  

References

Patterson, D (2010). Clinical Hypnosis for Pain Control. Washington: American Psychological Association. 

Patterson, D., & Jensen, M. (2003). Hypnosis and clinical pain. Psychological Bulletin, 129:4, 495-521

Valente, S. (2006). Hypnosis for pain management. Journal of Psychosocial Nursing, 44:2, 2-9

Wright, B. & Drummond, P. (2000). Rapid induction analgesia for the alleviation of procedural pain during burn care. Burns, 26, 275-282

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

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Peter Drummond

Address

Social Sciences Building room 1.020
Murdoch University
90 South Street
Murdoch WA 6150

Country

Australia

Phone

+61 8 9360 2415

Fax

Email

P.Drummond@murdoch.edu.au

Contact person for public queries

Name

Kathryn James

Address

Social Sciences Building room 1.020
Murdoch University
90 South Street
Murdoch WA 6150

Country

Australia

Phone

+61 458620032

Fax

Email

kate@go.net.au

Contact person for scientific queries

Name

Peter Drummond

Address

Social Sciences Building room 1.020
Murdoch University
90 South Street
Murdoch WA 6150

Country

Australia

Phone

+61 8 9360 2415

Fax

Email

P.Drummond@murdoch.edu.au

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.