Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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Participants (N=200 with complete data) will be healthy undergraduate students or community-based individuals. An experimental, randomised trial will be implemented, with participants randomly assigned to either five daily, 20-minute mindfulness meditation sessions or clinical hypnosis sessions. Repeated measures and experimental pain manipulation will be implemented. Aim 1 is to examine the effects of these two treatments on experimental pain outcomes. Aim 2 is to examine the moderators of these effects. Aim 3 is to determine the mediators underlying improved experimental pain outcomes. Results will refine theory and will inform the future streamlining of treatments to target those mechanisms shown to be of most critical importance.

Official Title
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An Experimental, Randomized Trial Comparing Mindfulness Meditation Versus Clinical Hypnosis for Acute Pain: a Test of Effects and Mechanisms

Conditions
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Mindfulness Meditation, Clinical Hypnosis

Intervention / Treatment
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* Behavioral: Mindfulness meditation
* Behavioral: Clinical hypnosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older; Able to read, speak and understand English. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind, two-arm, parallel-group randomized design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation<br>Participants in this arm will complete five, 20-minute mindfulness meditation sessions delivered over consecutive days. | Behavioral: Mindfulness meditation<br>* Participants in the mindfulness meditation condition will practice a breath and body focused meditation.<br>|
| Active Comparator: Clinical Hypnosis<br>Participants in this arm will complete five, 20-minute clinical hypnosis sessions delivered over consecutive days. | Behavioral: Clinical hypnosis<br>* Participants in clinical hypnosis will be guided in a hypnosis practice with suggestions tailored towards shifting pain appraisals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain unpleasantness | Numerical rating scale in response to exposure to a cold pressor task. | Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5) | 
| Pain intensity | Numerical rating scale in response to exposure to a cold pressor task. | Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5) | 
| Pain tolerance | 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. | Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological response to pain stimulus | Heart rate data | Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5) | 
| Mechanism: Attention Network Task | 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. | Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5) | 
| Mechanism: Mind Wandering Task | A computer based task that has been developed to allow assessment of three types of mind wandering. | Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5) | 
| Mechanism: Mindfulness | Five Facet Mindfulness Questionnaire-Short Form | Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5) | 
| Mechanism: Pain catastrophizing | Pain Catastrophizing Scale | Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5) | 
| Mechanism: Pain appraisals | Pain Appraisal Inventory | Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5) | 
| Mechanism: Pain-Related Cognitive Processes | Pain-Related Cognitive Process Questionnaire34 | Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5) | 
| Mechanism: Hypnotizability | Stanford Clinical Hypnotizability Scale | Baseline score at Experimental Session 1 (Day 1) | 
| Mechanism: Pre-treatment expectancies | Treatment Expectations Questionnaire | Baseline score at Experimental Session 1 (Day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness Meditation, Hypnosis, Acute Pain, Experimental Pain, Mechanisms