Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05323383




Registration number
NCT05323383
Ethics application status
Date submitted
15/03/2022
Date registered
12/04/2022
Date last updated
22/05/2023

Titles & IDs
Public title
The Effects and Mechanisms of Brief Mindfulness Meditation and Hypnosis for Pain
Scientific title
The Effects and Mechanisms of Brief Training in Mindfulness Meditation and Hypnosis for Pain Management, Relative to an Inert Control
Secondary ID [1] 0 0
2019/HE000347
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Chronic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Mindfulness Meditation
Behaviour - Self-hypnosis
Other interventions - Attention Control

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

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


Behaviour: 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.

Behaviour: 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 interventions: 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 code [1] 0 0
Behaviour
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Current pain intensity
Timepoint [1] 0 0
Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
Primary outcome [2] 0 0
Current pain unpleasantness
Timepoint [2] 0 0
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 [1] 0 0
Mechanism: Mindfulness
Timepoint [1] 0 0
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 [2] 0 0
Mechanism: Positive Affect
Timepoint [2] 0 0
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 [3] 0 0
Mechanism: Decentering
Timepoint [3] 0 0
Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)

Eligibility
Key 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 age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Washington
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05323383
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Melissa Day, Ph.D.
Address 0 0
Country 0 0
Phone 0 0
+61 7 3365 6421
Fax 0 0
Email 0 0
m.day@uq.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05323383