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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pain, Intractable, Pain, Chronic

Intervention / Treatment
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* Other: Meditation (1 x 20-minute guided audio training)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness meditation<br>focussed attention mindfulness meditation technique taught as means to reduce pain intensity and unpleasantness. | Other: Meditation (1 x 20-minute guided audio training)<br>* Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.<br>|
| Sham Comparator: Specific sham mindfulness meditation<br>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)<br>* Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.<br>|
| Sham Comparator: General sham mindfulness meditation<br>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)<br>* Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.<br>|
| No Intervention: Book listening control<br>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?
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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 |