Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain

NCT ID: NCT04786405

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2023-11-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mindfulness Meditation Clinical Hypnosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Mindfulness Meditation Hypnosis Acute Pain Experimental Pain Mechanisms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blind, two-arm, parallel-group randomized design.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The experimenter will remain blind to participant condition.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindfulness Meditation

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

Group Type EXPERIMENTAL

Mindfulness meditation

Intervention Type BEHAVIORAL

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

Clinical Hypnosis

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

Group Type ACTIVE_COMPARATOR

Clinical hypnosis

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness meditation

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

Intervention Type BEHAVIORAL

Clinical hypnosis

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Queensland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Queensland

Brisbane, Queensland, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

#2019000347

Identifier Type: -

Identifier Source: org_study_id