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

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: Recruiting
• Conditions: Pain; Chronic Pain
• Intervention / Treatment: Behavioral: Mindfulness Meditation; Behavioral: Self-hypnosis; Other: Attention Control

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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: Melissa Day, Ph.D.; Phone Number: +61 7 3365 6421; Email: m.day@uq.edu.au

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Current pain intensity	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	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

Outcome Measure	Measure Description	Time Frame
Mechanism: Mindfulness	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	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	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

• Sponsor: The University of Queensland
• Collaborators: University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID 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