Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04786405




Registration number
NCT04786405
Ethics application status
Date submitted
28/02/2021
Date registered
8/03/2021

Titles & IDs
Public title
Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain
Scientific title
An Experimental, Randomized Trial Comparing Mindfulness Meditation Versus Clinical Hypnosis for Acute Pain: a Test of Effects and Mechanisms
Secondary ID [1] 0 0
#2019000347
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mindfulness Meditation 0 0
Clinical Hypnosis 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Mindfulness meditation
BEHAVIORAL - Clinical hypnosis

Experimental: Mindfulness Meditation - Participants in this arm will complete five, 20-minute mindfulness meditation sessions delivered over consecutive days.

Active comparator: Clinical Hypnosis - Participants in this arm will complete five, 20-minute clinical hypnosis sessions delivered over consecutive days.


BEHAVIORAL: Mindfulness meditation
Participants in the mindfulness meditation condition will practice a breath and body focused meditation.

BEHAVIORAL: Clinical hypnosis
Participants in clinical hypnosis will be guided in a hypnosis practice with suggestions tailored towards shifting pain appraisals.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pain unpleasantness
Timepoint [1] 0 0
Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Primary outcome [2] 0 0
Pain intensity
Timepoint [2] 0 0
Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Primary outcome [3] 0 0
Pain tolerance
Timepoint [3] 0 0
Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary outcome [1] 0 0
Physiological response to pain stimulus
Timepoint [1] 0 0
Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary outcome [2] 0 0
Mechanism: Attention Network Task
Timepoint [2] 0 0
Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary outcome [3] 0 0
Mechanism: Mind Wandering Task
Timepoint [3] 0 0
Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary outcome [4] 0 0
Mechanism: Mindfulness
Timepoint [4] 0 0
Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary outcome [5] 0 0
Mechanism: Pain catastrophizing
Timepoint [5] 0 0
Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary outcome [6] 0 0
Mechanism: Pain appraisals
Timepoint [6] 0 0
Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary outcome [7] 0 0
Mechanism: Pain-Related Cognitive Processes
Timepoint [7] 0 0
Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary outcome [8] 0 0
Mechanism: Hypnotizability
Timepoint [8] 0 0
Baseline score at Experimental Session 1 (Day 1)
Secondary outcome [9] 0 0
Mechanism: Pre-treatment expectancies
Timepoint [9] 0 0
Baseline score at Experimental Session 1 (Day 1)

Eligibility
Key inclusion criteria
* 18 years of age or older;
* Able to read, speak and understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Pregnancy, heart or vascular disease, Raynaud's disease, sickle cell disease, seizure disorder, high blood pressure, or diabetes;
* Experience of recurrent fainting spells;
* Report of a chronic pain condition;
* Use of alcohol and/or pain medication in the last 24-hours;
* Currently receiving psychiatric care;
* Problems with allergic skin reactions or excessive bruising;
* Previous participation in a cold pressor experiment.
* All participants will be asked to consume a fruit box drink prior to the cold pressor to prevent vasovagal reactions.

These exclusion criteria are standard when using a cold pressor task in a healthy undergraduate population and ensure safe procedures to mitigate any potential risks.

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/11/2023
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will make available to interested researchers a data file containing the de-identified data used for each published article at the time that the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all of the variables used in any published article and a list of the variables in the data file (along with their variable labels) and email to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a copy of the data set (as an SPSS.sav file).


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/NCT04786405