ClinicalTrials.gg
CompletedNCT04602286Updated Feb 17, 2023

How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Pain Sample)

An interventional study of Meditation (1 x 20-minute guided audio training) in Pain, Intractable and Pain, Chronic, sponsored by The University of Queensland. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-17.

Sponsored by The University of Queensland · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
373
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pain, Intractable
  • Pain, Chronic
03

In context

Pain, Intractable

90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.

This study's enrollment of 373 is above the median of 60 across 64 interventional studies indexed under Pain, Intractable.

Browse Pain, Intractable studies →

Lead sponsor

The University of Queensland is the lead sponsor of 91 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
373 participants (actual)

Study arms

  • Experimental
    Mindfulness meditation

    "focussed attention" mindfulness meditation technique taught as means to reduce pain intensity and unpleasantness.

    Other: Meditation (1 x 20-minute guided audio training)

  • Sham comparator
    Specific sham mindfulness meditation

    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

    Other: Meditation (1 x 20-minute guided audio training)

  • Sham comparator
    General sham mindfulness meditation

    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

    Other: Meditation (1 x 20-minute guided audio training)

  • No intervention
    Book listening control

    this group completes no meditation training. They listen to a spoken excerpt from the audiobook "The Natural History and Antiquities of Selborne"

Interventions

  • OtherMeditation (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.

06

What researchers measure

Primary outcomes

  1. Pain intensity

    Assessed via a numerical rating scale (0=no pain, 10=most intense pain imaginable)

    Time frame: 40 minutes

  2. Pain Unpleasantness

    assessed via a numerical rating scale (0=no pain, 10=most unpleasant pain imaginable)

    Time frame: 40 minutes

Secondary outcomes

  1. Pain Catastrophizing

    assessed via the Pain Catastrophizing Scale (PCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing)

    Time frame: 40 minutes

Other outcomes

  1. Expectancy

    assessed via self-report questions (0=lowest expectancy, 10=highest expectancy)

    Time frame: 40 minutes

  2. Pain Reappraisal

    assessed via the Pain-related Cognitive Processes Questionnaire (PCPQ-R; 0=lowest reappraisal, 4=highest reappraisal)

    Time frame: 40 minutes

  3. Mindful observing

    assessed via the Five Facet Mindfulness Questionnaire Observing Subscale (FFMQ-O; 1=lowest observing, 5=highest observing)

    Time frame: 40 minutes

  4. Mindful non-reactivity

    assessed via the Five Facet Mindfulness Questionnaire Non-reacting Subscale (FFMQ-NR; 1=lowest non-reactivity, 5=highest non-reactivity)

    Time frame: 40 minutes

  5. State Mindfulness

    assessed via the State Mindfulness Survey (SMS; 1=lowest mindfulness, 21=highest mindfulness)

    Time frame: 40 minutes

  6. State Decentering

    assessed via the Metacognitive Processes of Decentering - State (MpoD-s; 0=lowest decentering, 3=highest decentering)

    Time frame: 40 minutes

07

Study locations

1 site
  • Health and Behavioural Sciences
    Brisbane, Queensland 4072, Australia
08

References and documents

Individual participant data

Plan to share: Yes — All of the individual trial-related participant data collected during the trial, after de-identification.

Supporting information: Statistical analysis plan, Informed consent form

Time frame: Immediately following publication up and for a further 10 years .

Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee. Initial contact should be directed to the contact person for scientific enquiries (Mr Jonathan Davies, jonathan.davies@uq.edu.au). Note: Requestors will need to sign a data access agreement.

Data sharing details ↗ · sites.google.com

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2020 to primary completion in Sep 2021, 11 months.

Of 26 interventional studies with no phase under Pain, Intractable, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 34. This study's 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2020
First posted
Oct 26, 2020
StartActual
Oct 28, 2020
Primary completionActual
Sep 28, 2021
CompletionActual
Sep 28, 2021
Last update
Feb 17, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04602286
Lead sponsor
The University of Queensland
Collaborators
University of Sydney, University of California, San Diego
Responsible party
Sponsor
First posted
Oct 26, 2020
Start date
Oct 28, 2020
Primary completion
Sep 28, 2021
Completion
Sep 28, 2021
Last update
Feb 17, 2023

Study contacts

Melissa Day, PhD
principal investigator · The University of Queensland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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