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Clinical Trials/NCT04602286
NCT04602286
Completed
Not Applicable

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

The University of Queensland1 site in 1 country373 target enrollmentOctober 28, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Intractable
Sponsor
The University of Queensland
Enrollment
373
Locations
1
Primary Endpoint
Pain intensity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 28, 2020
End Date
September 28, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Pain intensity

Time Frame: 40 minutes

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

Pain Unpleasantness

Time Frame: 40 minutes

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

Secondary Outcomes

  • Pain Catastrophizing(40 minutes)

Study Sites (1)

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