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Completed

NCT Number: NCT04786405

Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Queensland

Brisbane, Queensland, 4072, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Meditation

Behavioral

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

Clinical Hypnosis

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Physiological response to pain stimulus

    Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

    Heart rate data

  2. Mechanism: Attention Network Task

    Time frame: 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.

  3. Mechanism: Mind Wandering Task

    Time frame: 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.

  4. Mechanism: Mindfulness

    Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

    Five Facet Mindfulness Questionnaire-Short Form

  5. Mechanism: Pain catastrophizing

    Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

    Pain Catastrophizing Scale

  6. Mechanism: Pain appraisals

    Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

    Pain Appraisal Inventory

  7. Mechanism: Pain-Related Cognitive Processes

    Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

    Pain-Related Cognitive Process Questionnaire34

  8. Mechanism: Hypnotizability

    Time frame: Baseline score at Experimental Session 1 (Day 1)

    Stanford Clinical Hypnotizability Scale

  9. Mechanism: Pre-treatment expectancies

    Time frame: Baseline score at Experimental Session 1 (Day 1)

    Treatment Expectations Questionnaire

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 8, 2021
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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