Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

Sponsor

The University of Queensland (Other)

Overall Status

Recruiting

CT.gov ID

NCT04786405

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mindfulness Meditation Clinical Hypnosis	Behavioral: Mindfulness meditation Behavioral: Clinical hypnosis	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single-blind, two-arm, parallel-group randomized design.Single-blind, two-arm, parallel-group randomized design.

Masking:

Single (Outcomes Assessor)

Masking Description:

The experimenter will remain blind to participant condition.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 15, 2021

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Dec 15, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Mindfulness Meditation

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

Behavioral: Mindfulness meditation

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

Active Comparator: Clinical Hypnosis

Participants in this arm will complete five, 20-minute clinical hypnosis sessions delivered over consecutive days.

Behavioral: Clinical hypnosis

Participants in clinical hypnosis will be guided in a hypnosis practice with suggestions tailored towards shifting pain appraisals.

Outcome Measures

Primary Outcome Measures

Pain unpleasantness [Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)]
Numerical rating scale in response to exposure to a cold pressor task.
Pain intensity [Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)]
Numerical rating scale in response to exposure to a cold pressor task.
Pain tolerance [Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.