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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