Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

Mindfulness Meditation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04786405
• Other study ID #: #2019000347
• Status: Completed
• Phase: Phase 2
• Start date: March 15, 2021
• Est. completion date: November 29, 2023

Study information

• Verified date: November 2023
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Clinical Hypnosis
• Mindfulness Meditation

Intervention

Behavioral:
• Mindfulness meditation
Participants in the mindfulness meditation condition will practice a breath and body focused meditation.
• Clinical hypnosis
Participants in clinical hypnosis will be guided in a hypnosis practice with suggestions tailored towards shifting pain appraisals.

Locations

Country	Name	City	State
Australia	The University of Queensland	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
The University of Queensland

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Physiological response to pain stimulus	Heart rate data	Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary	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)
Secondary	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)
Secondary	Mechanism: Mindfulness	Five Facet Mindfulness Questionnaire-Short Form	Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary	Mechanism: Pain catastrophizing	Pain Catastrophizing Scale	Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary	Mechanism: Pain appraisals	Pain Appraisal Inventory	Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary	Mechanism: Pain-Related Cognitive Processes	Pain-Related Cognitive Process Questionnaire34	Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary	Mechanism: Hypnotizability	Stanford Clinical Hypnotizability Scale	Baseline score at Experimental Session 1 (Day 1)
Secondary	Mechanism: Pre-treatment expectancies	Treatment Expectations Questionnaire	Baseline score at Experimental Session 1 (Day 1)