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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
Date last updated
4/12/2023

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
This trial aims to determine the effects and mechanisms (mediators and moderators) of brief training in mindfulness meditation versus clinical hypnosis on acute, experimental pain.
Trial website
https://clinicaltrials.gov/study/NCT04786405
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04786405