Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

NCT04786405 | Completed Phase 2

• 1 other identifier: #2019000347
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Mindfulness Meditation; Clinical Hypnosis

Keywords

Mindfulness Meditation; Hypnosis; Acute Pain; Experimental Pain; Mechanisms

Outcome Measures

Primary Outcomes (3)

• 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cold pressor task with the time starting at the point of immersion and stopping when the hand, wrist and forearm were withdrawn from the refrigerated water.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 Outcomes (9)

• Physiological response to pain stimulus

  Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

• Mechanism: Attention Network Task

  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: Mindfulness

  Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

• Mechanism: Pain catastrophizing

  Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)

Study Arms (2)

Mindfulness Meditation

EXPERIMENTAL

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

Behavioral: Mindfulness meditation

Clinical Hypnosis

ACTIVE COMPARATOR

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

Behavioral: Clinical hypnosis

Interventions

Mindfulness meditation BEHAVIORAL

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

Mindfulness Meditation

Clinical hypnosis BEHAVIORAL

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

Clinical Hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• Able to read, speak and understand English.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (1)

The University of Queensland

Brisbane, Queensland, 4072, Australia

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Mindfulness; Hypnosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The experimenter will remain blind to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind, two-arm, parallel-group randomized design.

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 8, 2021
• Study Start: March 15, 2021
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)