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

NCT ID: NCT05323383

Last Updated: 2024-09-27

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

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-24

Study Completion Date

2024-12-31

Brief Summary

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

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.

Detailed Description

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

Conditions

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

Pain Chronic Pain

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, three-arm, parallel-group randomized design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes are assessed remotely via Qualtrics, thus the outcome "assessor" is blinded.

Study Groups

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

Mindfulness meditation

Participants in the mindfulness meditation condition will practice one, 20-minute breath and body focused meditation.

Group Type EXPERIMENTAL

Mindfulness Meditation

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Self-hypnosis

Intervention Type BEHAVIORAL

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.

Control

Participants in the attention control condition will listen to a 20-minute natural history recording.

Group Type OTHER

Attention Control

Intervention Type OTHER

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.

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 listen to a 20minute guided mindfulness meditation practice that holds the breath and body as the object of meditation.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

University of Washington

OTHER

Sponsor Role collaborator

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 RECRUITING

Countries

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

Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Melissa Day, Ph.D.

Role: CONTACT

+61 7 3365 6421

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Melissa Day, Ph.D.

Role: primary

+61 7 3365 6421

Other Identifiers

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

2019/HE000347

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mindfulness for Pain and Suicide
NCT05286112 ACTIVE_NOT_RECRUITING NA
Meditation for Pain
NCT03495726 COMPLETED NA
Mindfulness During COVID-19
NCT04319445 COMPLETED NA
Mindful Action for Pain
NCT03800654 COMPLETED NA
Somatic Tracking for Tinnitus
NCT06895824 RECRUITING NA