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Clinical Trials/NCT04786405
NCT04786405
Completed
Phase 2

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

The University of Queensland1 site in 1 country105 target enrollmentMarch 15, 2021

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Mindfulness Meditation
Sponsor
The University of Queensland
Enrollment
105
Locations
1
Primary Endpoint
Pain unpleasantness
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 15, 2021
End Date
November 29, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Pain unpleasantness

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Mechanism: Attention Network Task(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
  • Mechanism: Mindfulness(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
  • Physiological response to pain stimulus(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
  • Mechanism: Mind Wandering Task(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
  • Mechanism: Pain appraisals(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
  • Mechanism: Hypnotizability(Baseline score at Experimental Session 1 (Day 1))
  • Mechanism: Pain catastrophizing(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
  • Mechanism: Pain-Related Cognitive Processes(Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5))
  • Mechanism: Pre-treatment expectancies(Baseline score at Experimental Session 1 (Day 1))

Study Sites (1)

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