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

Primary Purpose

Pain, Intractable, Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Meditation (1 x 20-minute guided audio training)
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Intractable

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Health and Behavioural Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Sham Comparator

No Intervention

Arm Label

Mindfulness meditation

Specific sham mindfulness meditation

General sham mindfulness meditation

Book listening control

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Pain intensity
Assessed via a numerical rating scale (0=no pain, 10=most intense pain imaginable)
Pain Unpleasantness
assessed via a numerical rating scale (0=no pain, 10=most unpleasant pain imaginable)

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2020
Last Updated
February 14, 2023
Sponsor
The University of Queensland
Collaborators
University of Sydney, University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04602286
Brief Title
How Does Mindfulness Meditation Buffer the Negative Effects of Pain and Suffering in the COVID-19 World? (Pain Sample)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
September 28, 2021 (Actual)
Study Completion Date
September 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Queensland
Collaborators
University of Sydney, University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Intractable, Pain, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
373 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness meditation
Arm Type
Experimental
Arm Description
"focussed attention" mindfulness meditation technique taught as means to reduce pain intensity and unpleasantness.
Arm Title
Specific sham mindfulness meditation
Arm Type
Sham Comparator
Arm Description
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
Arm Title
General sham mindfulness meditation
Arm Type
Sham Comparator
Arm Description
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
Arm Title
Book listening control
Arm Type
No Intervention
Arm Description
this group completes no meditation training. They listen to a spoken excerpt from the audiobook "The Natural History and Antiquities of Selborne"
Intervention Type
Other
Intervention Name(s)
Meditation (1 x 20-minute guided audio training)
Intervention Description
Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Assessed via a numerical rating scale (0=no pain, 10=most intense pain imaginable)
Time Frame
40 minutes
Title
Pain Unpleasantness
Description
assessed via a numerical rating scale (0=no pain, 10=most unpleasant pain imaginable)
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
Pain Catastrophizing
Description
assessed via the Pain Catastrophizing Scale (PCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing)
Time Frame
40 minutes
Other Pre-specified Outcome Measures:
Title
Expectancy
Description
assessed via self-report questions (0=lowest expectancy, 10=highest expectancy)
Time Frame
40 minutes
Title
Pain Reappraisal
Description
assessed via the Pain-related Cognitive Processes Questionnaire (PCPQ-R; 0=lowest reappraisal, 4=highest reappraisal)
Time Frame
40 minutes
Title
Mindful observing
Description
assessed via the Five Facet Mindfulness Questionnaire Observing Subscale (FFMQ-O; 1=lowest observing, 5=highest observing)
Time Frame
40 minutes
Title
Mindful non-reactivity
Description
assessed via the Five Facet Mindfulness Questionnaire Non-reacting Subscale (FFMQ-NR; 1=lowest non-reactivity, 5=highest non-reactivity)
Time Frame
40 minutes
Title
State Mindfulness
Description
assessed via the State Mindfulness Survey (SMS; 1=lowest mindfulness, 21=highest mindfulness)
Time Frame
40 minutes
Title
State Decentering
Description
assessed via the Metacognitive Processes of Decentering - State (MpoD-s; 0=lowest decentering, 3=highest decentering)
Time Frame
40 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Day, PhD
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health and Behavioural Sciences
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4072
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://sites.google.com/view/uqcovidmeditation
Links:
URL
https://sydneypsy.qualtrics.com/jfe/form/SV_6P8sOROQ5eq8SpL?src=CTGP
Description
TAKE THE SURVEY NOW - LINK FOR PARTICIPANTS WISHING TO PARTICIPATE
URL
https://sites.google.com/view/uqcovidmeditation
Description
INFORMATION ABOUT THE STUDY

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

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