Mindfulness MeditationPhase 2NCT04786405
Mindfulness Meditation Versus Clinical Hypnosis for Acute, Experimental Pain
A Phase 2 study testing Mindfulness meditation and Clinical hypnosis in people with Mindfulness Meditation and Clinical Hypnosis, run by The University of Queensland at 1 site in Australia.
Trial summary
This trial aims to determine the effects and mechanisms (mediators and moderators) of brief training in mindfulness meditation versus clinical hypnosis on acute, experimental pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness Meditation, Clinical Hypnosis
- What is being tested?
- Mindfulness meditation and Clinical hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Mar 2021to 29 Nov 2023
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- Able to read, speak and understand English.
Who cannot join
- Pregnancy, heart or vascular disease, Raynaud's disease, sickle cell disease, seizure disorder, high blood pressure, or diabetes;
- Experience of recurrent fainting spells;
- Report of a chronic pain condition;
- Use of alcohol and/or pain medication in the last 24-hours;
- Currently receiving psychiatric care;
- Problems with allergic skin reactions or excessive bruising;
Show all 9Show fewer
- Previous participation in a cold pressor experiment.
- All participants will be asked to consume a fruit box drink prior to the cold pressor to prevent vasovagal reactions.
- These exclusion criteria are standard when using a cold pressor task in a healthy undergraduate population and ensure safe procedures to mitigate any potential risks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Experimental, Randomized Trial Comparing Mindfulness Meditation Versus Clinical Hypnosis for Acute Pain: a Test of Effects and Mechanisms
This trial aims to determine the effects and mechanisms (mediators and moderators) of brief training in mindfulness meditation versus clinical hypnosis on acute, experimental pain.
Read the detailed description
Participants (N=200 with complete data) will be healthy undergraduate students or community-based individuals. An experimental, randomised trial will be implemented, with participants randomly assigned to either five daily, 20-minute mindfulness meditation sessions or clinical hypnosis sessions. Repeated measures and experimental pain manipulation will be implemented. Aim 1 is to examine the effects of these two treatments on experimental pain outcomes. Aim 2 is to examine the moderators of these effects. Aim 3 is to determine the mediators underlying improved experimental pain outcomes. Results will refine theory and will inform the future streamlining of treatments to target those mechanisms shown to be of most critical importance.
- Conditions
- Mindfulness Meditation, Clinical Hypnosis
- Being tested
- Mindfulness meditation, Clinical hypnosis
- Keywords
- Mindfulness Meditation, Hypnosis, Acute Pain, Experimental Pain, Mechanisms
- Medical subject headings
- Acute 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 practice a breath and body focused meditation.
Clinical hypnosisBehavioural
Participants in clinical hypnosis will be guided in a hypnosis practice with suggestions tailored towards shifting pain appraisals.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation | Experimental | Participants in this arm will complete five, 20-minute mindfulness meditation sessions delivered over consecutive days. Receives: Behavioral: Mindfulness meditation |
| Clinical Hypnosis | Active comparator | Participants in this arm will complete five, 20-minute clinical hypnosis sessions delivered over consecutive days. Receives: Behavioral: Clinical hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain unpleasantness
Numerical rating scale in response to exposure to a cold pressor task.
Measured: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Pain intensity
Numerical rating scale in response to exposure to a cold pressor task.
Measured: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Pain tolerance
How long (in seconds) participants tolerate the cold pressor task with the time starting at the point of immersion and stopping when the hand, wrist and forearm were withdrawn from the refrigerated water.
Measured: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Secondary outcomes (9)
Physiological response to pain stimulus
Heart rate data
Measured: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Attention Network Task
A computer based task that has been developed to allow assessment of the functioning of the three major attentional networks; alerting, orienting, and executive attention.
Measured: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Mind Wandering Task
A computer based task that has been developed to allow assessment of three types of mind wandering.
Measured: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Mindfulness
Five Facet Mindfulness Questionnaire-Short Form
Measured: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Pain catastrophizing
Pain Catastrophizing Scale
Measured: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Pain appraisals
Pain Appraisal Inventory
Measured: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Pain-Related Cognitive Processes
Pain-Related Cognitive Process Questionnaire34
Measured: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Hypnotizability
Stanford Clinical Hypnotizability Scale
Measured: Baseline score at Experimental Session 1 (Day 1)
Mechanism: Pre-treatment expectancies
Treatment Expectations Questionnaire
Measured: Baseline score at Experimental Session 1 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start15 Mar 2021
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfulness MeditationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, two-arm, parallel-group randomized design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786405
- Sponsor's protocol ID
- #2019000347
- Status last verified
- Nov 2023
- First submitted
- 28 Feb 2021
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will make available to interested researchers a data file containing the de-identified data used for each published article at the time that the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all of the variables used in any published article and a list of the variables in the data file (along with their variable labels) and email to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a copy of the data set (as an SPSS.sav file).
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Experimental, Randomized Trial Comparing Mindfulness Meditation Versus Clinical Hypnosis for Acute Pain: a Test of Effects and Mechanisms
- ClinicalTrials.gov ID
- NCT04786405
- Acronym / sponsor ID
- #2019000347
- Conditions
- Mindfulness Meditation, Clinical Hypnosis
- Keywords
- Mindfulness Meditation, Hypnosis, Acute Pain, Experimental Pain, Mechanisms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 8 Mar 2021 (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.
This trial aims to determine the effects and mechanisms (mediators and moderators) of brief training in mindfulness meditation versus clinical hypnosis on acute, experimental pain.
Detailed description
Participants (N=200 with complete data) will be healthy undergraduate students or community-based individuals. An experimental, randomised trial will be implemented, with participants randomly assigned to either five daily, 20-minute mindfulness meditation sessions or clinical hypnosis sessions. Repeated measures and experimental pain manipulation will be implemented. Aim 1 is to examine the effects of these two treatments on experimental pain outcomes. Aim 2 is to examine the moderators of these effects. Aim 3 is to determine the mediators underlying improved experimental pain outcomes. Results will refine theory and will inform the future streamlining of treatments to target those mechanisms shown to be of most critical importance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, two-arm, parallel-group randomized design.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation | Experimental | Behavioral: Mindfulness meditationParticipants in this arm will complete five, 20-minute mindfulness meditation sessions delivered over consecutive days. |
| Clinical Hypnosis | Active comparator | Behavioral: Clinical hypnosisParticipants in this arm will complete five, 20-minute clinical hypnosis sessions delivered over consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older;
- Able to read, speak and understand English.
Key exclusion criteria (9 listed)
- Pregnancy, heart or vascular disease, Raynaud's disease, sickle cell disease, seizure disorder, high blood pressure, or diabetes;
- Experience of recurrent fainting spells;
- Report of a chronic pain condition;
- Use of alcohol and/or pain medication in the last 24-hours;
- Currently receiving psychiatric care;
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 practice a breath and body focused meditation. | Behavioural | Mindfulness Meditation |
| Clinical hypnosisParticipants in clinical hypnosis will be guided in a hypnosis practice with suggestions tailored towards shifting pain appraisals. | Behavioural | Clinical Hypnosis |
Primary outcome
Pain unpleasantness
Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Numerical rating scale in response to exposure to a cold pressor task.
Pain intensity
Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Numerical rating scale in response to exposure to a cold pressor task.
Pain tolerance
Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
How long (in seconds) participants tolerate the cold pressor task with the time starting at the point of immersion and stopping when the hand, wrist and forearm were withdrawn from the refrigerated water.
9 secondary outcomes
Physiological response to pain stimulus
Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Attention Network Task
Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Mind Wandering Task
Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Mindfulness
Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Pain catastrophizing
Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Pain appraisals
Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Pain-Related Cognitive Processes
Time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)
Mechanism: Hypnotizability
Time frame: Baseline score at Experimental Session 1 (Day 1)
Mechanism: Pre-treatment expectancies
Time frame: Baseline score at Experimental Session 1 (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No. We will make available to interested researchers a data file containing the de-identified data used for each published article at the time that the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all of the variables used in any published article and a list of the variables in the data file (along with their variable labels) and email to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a copy of the data set (as an SPSS.sav file).
Related trials for Mindfulness Meditation
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruiting
Meditation Apps for Stress Management in Black Women
Psychological Stress
RecruitingPhase 3
E-Mindfulness Approaches for Living After Breast Cancer
Breast Cancer, Depression
Active, not recruiting
Online Mindfulness-Based Stress Reduction for the Mental Health of Healthcare Professionals
Occupational Stress or Workplace Stress, Burnout, Professionals
Not yet recruitingEarly Phase 1
Medication vs. Meditation for Chronic Knee Osteoarthritis
Knee Osteoarthristis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mindfulness meditation and Clinical hypnosis in people with Mindfulness Meditation and Clinical Hypnosis, 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 4 Dec 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain unpleasantness (time frame: Change from Experimental Session 1 (Day 1) to Experimental Session 5 (Day 5)). The study lists 3 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 4 Dec 2023.