Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Mindfulness Meditation; Clinical Hypnosis
• Intervention / Treatment: Behavioral: Mindfulness meditation; Behavioral: Clinical hypnosis

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4072
      • The University of Queensland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: The University of Queensland

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: February 28, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Hypnosis; Acute Pain; Mindfulness Meditation; Mechanisms; Experimental Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: #2019000347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will make available to interested researchers a data file containing the de-identified data used for each published article at the time that the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all of the variables used in any published article and a list of the variables in the data file (along with their variable labels) and email to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a copy of the data set (as an SPSS.sav file).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No