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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323383
• Other study ID #: 2019/HE000347
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: The University of Queensland
• Contact: Melissa Day, Ph.D.
• Phone: +61 7 3365 6421
• Email: m.day[@]uq.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

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.
• 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:
• 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.

Locations

Country	Name	City	State
Australia	The University of Queensland	Brisbane	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
The University of Queensland	University of Washington

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)