PainNCT05323383
The Effects and Mechanisms of Brief Mindfulness Meditation and Hypnosis for Pain
A study testing Mindfulness Meditation and Self-hypnosis in people with Pain and Chronic Pain, run by The University of Queensland at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Pain
- What is being tested?
- Mindfulness Meditation and Self-hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
The University of Queensland
Brisbane, Queensland, 4072
Melissa Day, Ph.D., +61 7 3365 6421, m.day@uq.edu.au
About this study
Official title: 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.
- Conditions
- Pain, Chronic Pain
- Being tested
- Mindfulness Meditation, Self-hypnosis, Attention Control
- Medical subject headings
- Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
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-hypnosisBehavioural
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.
Attention ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness meditation | Experimental | Participants in the mindfulness meditation condition will practice one, 20-minute breath and body focused meditation. Receives: Behavioral: Mindfulness Meditation |
| Self-Hypnosis | Active comparator | Participants in self-hypnosis will practice one, 20-minute audio-guided hypnosis session with suggestions tailored towards enhancing positive affect and fostering decentering. Receives: Behavioral: Self-hypnosis |
| Control | Other | Participants in the attention control condition will listen to a 20-minute natural history recording. Receives: Other: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current pain intensity
Numerical rating scale ranging from 0-10
Measured: 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
Measured: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
Secondary outcomes (3)
Mechanism: Mindfulness
State Mindfulness Scale with items ranging from 1-5
Measured: 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
Measured: 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
Measured: Change from pre- (Time 1; start of survey) to post-20-min training (Time 2; following completion of the one, 20-min training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start24 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, three-arm, parallel-group randomized design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323383
- Sponsor's protocol ID
- 2019/HE000347
- Status last verified
- Aug 2024
- First submitted
- 15 Mar 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Mechanisms of Brief Training in Mindfulness Meditation and Hypnosis for Pain Management, Relative to an Inert Control
- ClinicalTrials.gov ID
- NCT05323383
- Acronym / sponsor ID
- 2019/HE000347
- Conditions
- Pain, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Single-blind, three-arm, parallel-group randomized design
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation | Experimental | Behavioral: Mindfulness MeditationParticipants in the mindfulness meditation condition will practice one, 20-minute breath and body focused meditation. |
| Self-Hypnosis | Active comparator | Behavioral: Self-hypnosisParticipants in self-hypnosis will practice one, 20-minute audio-guided hypnosis session with suggestions tailored towards enhancing positive affect and fostering decentering. |
| Control | Other | Other: Attention ControlParticipants in the attention control condition will listen to a 20-minute natural history recording. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness MeditationParticipants 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. | Behavioural | Mindfulness meditation |
| Self-hypnosisParticipants 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. | Behavioural | Self-Hypnosis |
| Attention ControlControl 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. | Other | Control |
Primary outcome
Current pain intensity
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)
Numerical rating scale ranging from 0-10
Current pain unpleasantness
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)
Numerical rating scale ranging from 0-10
3 secondary outcomes
Mechanism: Mindfulness
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)
Mechanism: Positive Affect
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)
Mechanism: Decentering
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation and Self-hypnosis in people with Pain and Chronic Pain, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Day, Ph.D. (+61 7 3365 6421, m.day@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current pain intensity (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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.