The Effects and Mechanisms of Brief Mindfulness Meditation and Hypnosis for Pain

September 25, 2024 updated by: The University of Queensland

The Effects and Mechanisms of Brief Training in Mindfulness Meditation and Hypnosis for Pain Management, Relative to an Inert Control

The aim of this study is to determine the effects and mechanisms of 1 x 20-min training in mindfulness meditation and self-hypnosis relative to an inert control. Participants will be randomly assigned to condition. The dual primary outcomes will be pre- to post-training changes in current pain intensity and pain unpleasantness. The active treatments are hypothesized to produce greater reductions in pain outcomes than the control. It is also hypothesized that change in mindfulness will be a mediator specific to mindfulness meditation, while change in affect and decentering will be mediators of the hypnosis condition. Moderators of response will also be explored.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Melissa Day, Ph.D.
  • Phone Number: +61 7 3365 6421
  • Email: m.day@uq.edu.au

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4072
        • Recruiting
        • The University of Queensland
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must be 18 years of age;
  • Experience chronic or recurrent pain;
  • Have access to a computer, phone or tablet with internet capability; and
  • Be able to read and understand English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness meditation
Participants in the mindfulness meditation condition will practice one, 20-minute breath and body focused meditation.
Behavioral: Mindfulness Meditation
Participants in the mindfulness meditation condition will listen to a 20minute guided mindfulness meditation practice that holds the breath and body as the object of meditation.
Active Comparator: Self-Hypnosis
Participants in self-hypnosis will practice one, 20-minute audio-guided hypnosis session with suggestions tailored towards enhancing positive affect and fostering decentering.
Behavioral: Self-hypnosis
Participants in self-hypnosis will listen to a 20-minute audio-guided hypnosis practice with an induction phase, followed by suggestions tailored towards shifts in affect and decentering, and then a re-alerting with post-hypnotic suggestions phase.
Other: Control
Participants in the attention control condition will listen to a 20-minute natural history recording.
Other: Attention Control
Control participants will listen to a 20-minute natural history recording which was chosen as past research has found that individuals who listen to it report this to be a neutral, but relaxing passage, and it has been used as an effective control condition in previous research.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Current pain intensity
Time Frame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
Numerical rating scale ranging from 0-10
Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
Current pain unpleasantness
Time Frame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
Numerical rating scale ranging from 0-10
Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mechanism: Mindfulness
Time Frame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
State Mindfulness Scale with items ranging from 1-5
Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
Mechanism: Positive Affect
Time Frame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
PANAS-X
Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
Mechanism: Decentering
Time Frame: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
State decentering MpoD-s
Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Queensland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019/HE000347

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The dataset generated and analysed during the current study will be available from the corresponding author on reasonable request once published. The data will not be not publicly available due to ethical restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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