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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Chronic; Pain, Intractable
• Intervention / Treatment: Other: Meditation (1 x 20-minute guided audio training)

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 Type: Interventional
• Enrollment (Actual): 373
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4072
      • Health and Behavioural Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
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); Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
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); Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Catastrophizing	assessed via the Pain Catastrophizing Scale (PCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing)	40 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expectancy	assessed via self-report questions (0=lowest expectancy, 10=highest expectancy)	40 minutes
Pain Reappraisal	assessed via the Pain-related Cognitive Processes Questionnaire (PCPQ-R; 0=lowest reappraisal, 4=highest reappraisal)	40 minutes
Mindful observing	assessed via the Five Facet Mindfulness Questionnaire Observing Subscale (FFMQ-O; 1=lowest observing, 5=highest observing)	40 minutes
Mindful non-reactivity	assessed via the Five Facet Mindfulness Questionnaire Non-reacting Subscale (FFMQ-NR; 1=lowest non-reactivity, 5=highest non-reactivity)	40 minutes
State Mindfulness	assessed via the State Mindfulness Survey (SMS; 1=lowest mindfulness, 21=highest mindfulness)	40 minutes
State Decentering	assessed via the Metacognitive Processes of Decentering - State (MpoD-s; 0=lowest decentering, 3=highest decentering)	40 minutes

Collaborators and Investigators

• Sponsor: The University of Queensland
• Collaborators: University of California, San Diego; University of Sydney
• Investigators: Principal Investigator: Melissa Day, PhD, The University of Queensland

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): September 28, 2021
• Study Completion (Actual): September 28, 2021

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Pain, Intractable
• Other Study ID Numbers: 2019000347-S4P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual trial-related participant data collected during the trial, after de-identification.
• IPD Sharing Time Frame: Immediately following publication up and for a further 10 years .

IPD Sharing 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.

• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No