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

NCT04602286 | Completed

• 1 other identifier: 2019000347-S4P
• Study Type: interventional
• Target: 373
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Intractable; Pain, Chronic

Outcome Measures

Primary Outcomes (2)

• Pain intensity

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

  40 minutes

• Pain Unpleasantness

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

  40 minutes

Secondary Outcomes (1)

• Pain Catastrophizing

  40 minutes

Other Outcomes (6)

• Expectancy

  40 minutes

• Pain Reappraisal

  40 minutes

• Mindful observing

  40 minutes

Study Arms (4)

Mindfulness meditation

EXPERIMENTAL

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

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

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

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"

Interventions

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.

General sham mindfulness meditation; Mindfulness meditation; Specific sham mindfulness meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Queensland: lead
• University of Sydney: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Health and Behavioural Sciences

Brisbane, Queensland, 4072, Australia

Location

Related Publications (1)

• 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.

  PMID: 37310492 DERIVED

Related Links

• TAKE THE SURVEY NOW - LINK FOR PARTICIPANTS WISHING TO PARTICIPATE
• INFORMATION ABOUT THE STUDY

MeSH Terms

Conditions

Pain, Intractable; Chronic Pain

Interventions

Meditation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Melissa Day, PhD

  The University of Queensland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 26, 2020
• Study Start: October 28, 2020
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: February 17, 2023

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• 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.

Locations

AU (1)