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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
An Experimental, Randomized Trial Comparing Mindfulness Meditation Versus Clinical Hypnosis for Acute Pain: a Test of Effects and Mechanisms
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Secondary ID [1]
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#2019000347
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mindfulness Meditation
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Clinical Hypnosis
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Condition category
Condition code
Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Mindfulness meditation
Behaviour - 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.
Behaviour: Mindfulness meditation
Participants in the mindfulness meditation condition will practice a breath and body focused meditation.
Behaviour: Clinical hypnosis
Participants in clinical hypnosis will be guided in a hypnosis practice with suggestions tailored towards shifting pain appraisals.
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pain unpleasantness
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Assessment method [1]
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Numerical rating scale in response to exposure to a cold pressor task.
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Timepoint [1]
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Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
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Primary outcome [2]
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Pain intensity
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Assessment method [2]
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Numerical rating scale in response to exposure to a cold pressor task.
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Timepoint [2]
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Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
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Primary outcome [3]
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Pain tolerance
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Assessment method [3]
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How long (in seconds) participants tolerate the cold pressor task with the time starting at the point of immersion and stopping when the hand, wrist and forearm were withdrawn from the refrigerated water.
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Timepoint [3]
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Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
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Secondary outcome [1]
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Physiological response to pain stimulus
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Assessment method [1]
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Heart rate data
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Timepoint [1]
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Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
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Secondary outcome [2]
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Mechanism: Attention Network Task
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Assessment method [2]
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A computer based task that has been developed to allow assessment of the functioning of the three major attentional networks; alerting, orienting, and executive attention.
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Timepoint [2]
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Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
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Secondary outcome [3]
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Mechanism: Mind Wandering Task
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Assessment method [3]
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A computer based task that has been developed to allow assessment of three types of mind wandering.
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Timepoint [3]
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Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
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Secondary outcome [4]
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Mechanism: Mindfulness
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Assessment method [4]
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Five Facet Mindfulness Questionnaire-Short Form
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Timepoint [4]
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Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
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Secondary outcome [5]
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Mechanism: Pain catastrophizing
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Assessment method [5]
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Pain Catastrophizing Scale
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Timepoint [5]
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Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
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Secondary outcome [6]
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Mechanism: Pain appraisals
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Assessment method [6]
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Pain Appraisal Inventory
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Timepoint [6]
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Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
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Secondary outcome [7]
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Mechanism: Pain-Related Cognitive Processes
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Assessment method [7]
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Pain-Related Cognitive Process Questionnaire34
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Timepoint [7]
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Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
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Secondary outcome [8]
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Mechanism: Hypnotizability
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Assessment method [8]
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Stanford Clinical Hypnotizability Scale
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Timepoint [8]
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Baseline score at Experimental Session 1 (Day 1)
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Secondary outcome [9]
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Mechanism: Pre-treatment expectancies
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Assessment method [9]
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Treatment Expectations Questionnaire
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Timepoint [9]
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Baseline score at Experimental Session 1 (Day 1)
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Eligibility
Key inclusion criteria
- 18 years of age or older;
- Able to read, speak and understand English.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/03/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/11/2023
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Sample size
Target
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Accrual to date
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Final
105
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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The University of Queensland - Brisbane
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Recruitment postcode(s) [1]
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4072 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04786405
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04786405
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