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Completed

NCT Number: NCT04602286

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

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.

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Key information

Conditions

Pain, Intractable Chronic Pain Neurologic Manifestations Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health and Behavioural Sciences

Brisbane, Queensland, 4072, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Pain intensity

    Time frame: 40 minutes

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

  2. Pain Unpleasantness

    Time frame: 40 minutes

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

Secondary outcomes

  1. Pain Catastrophizing

    Time frame: 40 minutes

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

Other outcomes

  1. Expectancy

    Time frame: 40 minutes

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

  2. Pain Reappraisal

    Time frame: 40 minutes

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

  3. Mindful observing

    Time frame: 40 minutes

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

  4. Mindful non-reactivity

    Time frame: 40 minutes

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

  5. State Mindfulness

    Time frame: 40 minutes

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

  6. State Decentering

    Time frame: 40 minutes

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

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

  • University of California, San Diego
  • University of Sydney

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 26, 2020
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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