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

Pain, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602286
• Other study ID #: 2019000347-S4P
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: September 28, 2021

Study information

• Verified date: October 2020
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 coronavirus pandemic. This study includes four interrelated aims that will probe these effects and interactions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: September 28, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic
• Pain, Intractable

Intervention

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.

Locations

Country	Name	City	State
Australia	Health and Behavioural Sciences	Brisbane	Queensland

Sponsors (3)

Lead Sponsor	Collaborator
The University of Queensland	University of California, San Diego, University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Expectancy	assessed via self-report questions (0=lowest expectancy, 10=highest expectancy)	40 minutes
Other	Pain Reappraisal	assessed via the Pain-related Cognitive Processes Questionnaire (PCPQ-R; 0=lowest reappraisal, 4=highest reappraisal)	40 minutes
Other	Mindful observing	assessed via the Five Facet Mindfulness Questionnaire Observing Subscale (FFMQ-O; 1=lowest observing, 5=highest observing)	40 minutes
Other	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
Other	State Mindfulness	assessed via the State Mindfulness Survey (SMS; 1=lowest mindfulness, 21=highest mindfulness)	40 minutes
Other	State Decentering	assessed via the Metacognitive Processes of Decentering - State (MpoD-s; 0=lowest decentering, 3=highest decentering)	40 minutes
Primary	Pain intensity	Assessed via a numerical rating scale (0=no pain, 10=most intense pain imaginable)	40 minutes
Primary	Pain Unpleasantness	assessed via a numerical rating scale (0=no pain, 10=most unpleasant pain imaginable)	40 minutes
Secondary	Pain Catastrophizing	assessed via the Pain Catastrophizing Scale (PCS; 0=no catastrophizing, 52=highest catastrophizing, 30+=clinically significant catastrophizing)	40 minutes

External Links

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