Pain, IntractableNCT04602286
How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Pain Sample)
A study testing Meditation (1 x 20-minute guided audio training) in people with Pain, Intractable and Pain, Chronic, run by The University of Queensland at 1 site in Australia.
Trial summary
Both mindfulness meditation and expectancy effects are known to reduce pain intensity, pain unpleasantness and pain catastrophizing, but it is unknown whether and how expectancy effects contribute to the overall effect of mindfulness meditation on these outcomes, especially during significant global events such as the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Intractable, Pain, Chronic
- What is being tested?
- Meditation (1 x 20-minute guided audio training)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 373 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Oct 2020to 28 Sep 2021
- 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
- At least 18 years of age
- Recurrent pain (two or more days in the last month)
- Chronic pain (pain most days in the last three months)
- Able to read and understand English
Who cannot join
- Not experiencing recurrent or chronic pain
- Incomplete or invalid data (response time < 32 minutes, failing attention checks)
- Completing the 20-minute training module in < 18 minutes or > 90 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Online Randomized Controlled Trial Comparing the Effects of Mindfulness, Sham Mindfulness and Book Listening Control on Pain Experience in Adults With Recurrent and Chronic Pain
Both mindfulness meditation and expectancy effects are known to reduce pain intensity, pain unpleasantness and pain catastrophizing, but it is unknown whether and how expectancy effects contribute to the overall effect of mindfulness meditation on these outcomes, especially during significant global events such as the coronavirus pandemic. This study includes four interrelated aims that will probe these effects and interactions.
Read the detailed description
As many as 1 in 4 Australians experience chronic pain. Further, it is yet unknown the effects of the Coronavirus (COVID-19) pandemic on Australians with or at risk of chronic pain. There is a critical need for the development and evaluation of fast-acting non-pharmaceutical treatments that have the capacity to target the multidimensional nature of chronic pain. This study will investigate how mindfulness meditation and common expectancy effects interact and will further characterise the mechanisms underlying these effects. Results will ultimately lead to targeted interventions that more effectively engage cognitive mechanisms associated with pain attenuation.
- Conditions
- Pain, Intractable, Pain, Chronic
- Being tested
- Meditation (1 x 20-minute guided audio training)
- Medical subject headings
- Pain, Intractable, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation (1 x 20-minute guided audio training)Other
Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness meditation | Experimental | "focussed attention" mindfulness meditation technique taught as means to reduce pain intensity and unpleasantness. Receives: Other: Meditation (1 x 20-minute guided audio training) |
| Specific sham mindfulness meditation | Sham comparator | a training session designed to specifically match the real mindfulness training while lacking the proposed active elements of mindfulness training. Delivered as a means to elicit placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness Receives: Other: Meditation (1 x 20-minute guided audio training) |
| General sham mindfulness meditation | Sham comparator | a training session designed to generally match focussed-attention mindfulness meditation while maintaining greater distance from proposed mindfulness mechanisms. Delivered as a means to elicit placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness Receives: Other: Meditation (1 x 20-minute guided audio training) |
| Book listening control | No intervention | this group completes no meditation training. They listen to a spoken excerpt from the audiobook "The Natural History and Antiquities of Selborne" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Assessed via a numerical rating scale (0=no pain, 10=most intense pain imaginable)
Measured: 40 minutes
Pain Unpleasantness
assessed via a numerical rating scale (0=no pain, 10=most unpleasant pain imaginable)
Measured: 40 minutes
Secondary outcomes (1)
Pain Catastrophizing
assessed via the Pain Catastrophizing Scale (PCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing)
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start28 Oct 2020
- Primary completion28 Sep 2021
- Study completion28 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, IntractableStudies 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
- 4 x (2) mixed design, with training (mindfulness vs specific sham mindfulness vs general sham mindfulness vs book listening control, between subjects) and time (pre-treatment vs post-treatment, within-subjects) as factors.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sydney, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Melissa Day, PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602286
- Sponsor's protocol ID
- 2019000347-S4P
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual trial-related participant data collected during the trial, after de-identification.
Publications
Davies JN, Colagiuri B, Sharpe L, Day MA. Placebo effects contribute to brief online mindfulness interventions for chronic pain: results from an online randomized sham-controlled trial. Pain. 2023 Oct 1;164(10):2273-2284. doi: 10.1097/j.pain.0000000000002928. Epub 2023 Jun 9.
PubMed 37310492
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Randomized Controlled Trial Comparing the Effects of Mindfulness, Sham Mindfulness and Book Listening Control on Pain Experience in Adults With Recurrent and Chronic Pain
- ClinicalTrials.gov ID
- NCT04602286
- Acronym / sponsor ID
- 2019000347-S4P
- Conditions
- Pain, Intractable, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- University of Sydney, University of California, San Diego
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 28 Sep 2021 (actual)
- Study completion
- 28 Sep 2021 (actual)
- First posted
- 26 Oct 2020 (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.
Both mindfulness meditation and expectancy effects are known to reduce pain intensity, pain unpleasantness and pain catastrophizing, but it is unknown whether and how expectancy effects contribute to the overall effect of mindfulness meditation on these outcomes, especially during significant global events such as the coronavirus pandemic. This study includes four interrelated aims that will probe these effects and interactions.
Detailed description
As many as 1 in 4 Australians experience chronic pain. Further, it is yet unknown the effects of the Coronavirus (COVID-19) pandemic on Australians with or at risk of chronic pain. There is a critical need for the development and evaluation of fast-acting non-pharmaceutical treatments that have the capacity to target the multidimensional nature of chronic pain. This study will investigate how mindfulness meditation and common expectancy effects interact and will further characterise the mechanisms underlying these effects. Results will ultimately lead to targeted interventions that more effectively engage cognitive mechanisms associated with pain attenuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 x (2) mixed design, with training (mindfulness vs specific sham mindfulness vs general sham mindfulness vs book listening control, between subjects) and time (pre-treatment vs post-treatment, within-subjects) as factors.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation | Experimental | Other: Meditation (1 x 20-minute guided audio training)"focussed attention" mindfulness meditation technique taught as means to reduce pain intensity and unpleasantness. |
| Specific sham mindfulness meditation | Sham comparator | Other: Meditation (1 x 20-minute guided audio training)a training session designed to specifically match the real mindfulness training while lacking the proposed active elements of mindfulness training. Delivered as a means to elicit placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness |
| General sham mindfulness meditation | Sham comparator | Other: Meditation (1 x 20-minute guided audio training)a training session designed to generally match focussed-attention mindfulness meditation while maintaining greater distance from proposed mindfulness mechanisms. Delivered as a means to elicit placebo-mediated (but not mindfulness-mediated) reductions in pain intensity and unpleasantness |
| Book listening control | No intervention | –this group completes no meditation training. They listen to a spoken excerpt from the audiobook "The Natural History and Antiquities of Selborne" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Recurrent pain (two or more days in the last month)
- Chronic pain (pain most days in the last three months)
- Able to read and understand English
Key exclusion criteria (3 listed)
- Not experiencing recurrent or chronic pain
- Incomplete or invalid data (response time < 32 minutes, failing attention checks)
- Completing the 20-minute training module in < 18 minutes or > 90 minutes
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 |
|---|---|---|
| Meditation (1 x 20-minute guided audio training)Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions. | Other | General sham mindfulness meditation, Mindfulness meditation, Specific sham mindfulness meditation |
Primary outcome
Pain intensity
Time frame: 40 minutes
Assessed via a numerical rating scale (0=no pain, 10=most intense pain imaginable)
Pain Unpleasantness
Time frame: 40 minutes
assessed via a numerical rating scale (0=no pain, 10=most unpleasant pain imaginable)
1 secondary outcome
Pain Catastrophizing
Time frame: 40 minutes
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 17 Feb 2023.
- Derived from this study: PubMed 37310492Davies JN, Colagiuri B, Sharpe L, Day MA. Placebo effects contribute to brief online mindfulness interventions for chronic pain: results from an online randomized sham-controlled trial. Pain. 2023 Oct 1;164(10):2273-2284. doi: 10.1097/j.pain.0000000000002928. Epub 2023 Jun 9.
- TAKE THE SURVEY NOW - LINK FOR PARTICIPANTS WISHING TO PARTICIPATELink provided by the sponsor.
- INFORMATION ABOUT THE STUDYLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All of the individual trial-related participant data collected during the trial, after de-identification.
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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.
Melissa Day, PhD principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation (1 x 20-minute guided audio training) in people with Pain, Intractable and Pain, Chronic, 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 3 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 17 Feb 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. Some participants in this study may receive a placebo. 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?
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 intensity (time frame: 40 minutes). 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?
On the ClinicalTrials.gov record for NCT04602286, which also lists 1 linked publication.
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 17 Feb 2023.