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

Primary Purpose

Pain, Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Mindfulness Meditation
Self-hypnosis
Attention Control
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of QueenslandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Mindfulness meditation

Self-Hypnosis

Control

Arm Description

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

Participants in self-hypnosis will practice one, 20-minute audio-guided hypnosis session with suggestions tailored towards enhancing positive affect and fostering decentering.

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

Outcomes

Primary Outcome Measures

Current pain intensity
Numerical rating scale ranging from 0-10
Current pain unpleasantness
Numerical rating scale ranging from 0-10

Secondary Outcome Measures

Mechanism: Mindfulness
State Mindfulness Scale with items ranging from 1-5
Mechanism: Positive Affect
PANAS-X
Mechanism: Decentering
State decentering MpoD-s

Full Information

First Posted
March 15, 2022
Last Updated
May 18, 2023
Sponsor
The University of Queensland
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05323383
Brief Title
The Effects and Mechanisms of Brief Mindfulness Meditation and Hypnosis for Pain
Official Title
The Effects and Mechanisms of Brief Training in Mindfulness Meditation and Hypnosis for Pain Management, Relative to an Inert Control
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Queensland
Collaborators
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind, three-arm, parallel-group randomized design
Masking
Outcomes Assessor
Masking Description
Outcomes are assessed remotely via Qualtrics, thus the outcome "assessor" is blinded.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness meditation
Arm Type
Experimental
Arm Description
Participants in the mindfulness meditation condition will practice one, 20-minute breath and body focused meditation.
Arm Title
Self-Hypnosis
Arm Type
Active Comparator
Arm Description
Participants in self-hypnosis will practice one, 20-minute audio-guided hypnosis session with suggestions tailored towards enhancing positive affect and fostering decentering.
Arm Title
Control
Arm Type
Other
Arm Description
Participants in the attention control condition will listen to a 20-minute natural history recording.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation
Intervention Description
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
Intervention Name(s)
Self-hypnosis
Intervention Description
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
Other
Intervention Name(s)
Attention Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Current pain intensity
Description
Numerical rating scale ranging from 0-10
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)
Title
Current pain unpleasantness
Description
Numerical rating scale ranging from 0-10
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)
Secondary Outcome Measure Information:
Title
Mechanism: Mindfulness
Description
State Mindfulness Scale with items ranging from 1-5
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)
Title
Mechanism: Positive Affect
Description
PANAS-X
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)
Title
Mechanism: Decentering
Description
State decentering MpoD-s
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Day, Ph.D.
Phone
+61 7 3365 6421
Email
m.day@uq.edu.au
Facility Information:
Facility Name
The University of Queensland
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4072
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Day, Ph.D.
Phone
+61 7 3365 6421
Email
m.day@uq.edu.au

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

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

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