Clinical trial NCT06095687: Mind-body Therapies for Injury-related Pain Management in Elite Athletes
Official title: Investigating the Effectiveness of Mindfulness Meditation and Clinical Hypnosis for Injury-related Pain Management in Elite Athletes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pain, Acute
Keywords: Mindfulness meditation
Clinical hypnosis
Elite athletes
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: University of Alabama, Tuscaloosa
First posted: 2023-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Replicated single case experimental design
Primary purpose: TREATMENT

Brief summary: This study will utilize a replicated single case experimental design (RSCD) to investigate the effectiveness of a brief mindfulness meditation (MM) vs clinical hypnosis (HYP) training for improving pain in injured elite athletes. The primary outcome is change in pain intensity. It is hypothesized that: (1) both treatments will engender clinically meaningful improvement in pain intensity; (2) change in cognitive processes will be a unique mechanism underlying improved pain outcome in MM, and (3) change in cognitive content will be a unique mechanism underlying improved pain outcome in HYP. This research program has the potential to reduce athletes' uncertainty around pain, time out with injury and improve pain management during rehabilitation and recovery from injury.

Detailed description: The proposed program of research will utilize our current understanding of the Behavioral Inhibition System and Behavioral Activation System (BIS-BAS) model of pain and mind-body therapies and apply it to pain experienced by injured elite athletes. This study will be a replicated single case experimental design (RSCD), which will investigate the effectiveness of a brief mindfulness meditation (MM) vs clinical hypnosis (HYP) training for improving the primary outcome of pain intensity in injured elite athletes. It will also investigate the potential mechanism role of change in cognitive content and cognitive processes in underlying the effects of these mind-body therapies. It is hypothesized that: (1) both treatments will engender clinically meaningful improvement in pain intensity; (2) change in cognitive processes will be a unique mechanism underlying improved pain outcome in MM, and (3) change in cognitive content will be a unique mechanism underlying improved pain outcome in HYP. This research program has the potential to reduce athletes' uncertainty around pain, time out with injury and improve pain management during rehabilitation and recovery from injury.

Eligibility criteria: Inclusion Criteria:

* be an elite athlete (i.e., competing at international or division 1 varsity level),
* currently have a sport or exercise-related injury that resulted in an average pain intensity greater than or equal to 3 on a 0-10 numerical rating scale in the past week, and for which the predicted recovery time at the point of study enrolment is greater than 5 weeks,
* Be 18 or over.
* Read, speak, and understand the English language.
* Have access to the internet on a computer or smartphone.
* Have access to a set of headphones.
* Be willing to be randomly assigned to both conditions and listen to five 20-minute treatment sessions.
* Be willing to participate in a daily survey for 25 consecutive days.

Primary outcomes:
measure: Numerical Rating Scale (NRS) of Current Pain Intensity
timeFrame: Assessed online daily during randomized baseline length of 5, 10 or 15 days, 5 day treatment period, and randomized post-treatment phase of 5, 10 or 15 days of assessment
Secondary outcomes:
measure: Numerical Rating Scale (NRS) of Current Pain Unpleasantness
timeFrame: Assessed online daily during randomized baseline length of 5, 10 or 15 days, 5 day treatment period, and randomized post-treatment phase of 5, 10 or 15 days of assessment
Other outcomes:
measure: Depression Anxiety Stress Scale, 9-item SF, Stress Subscale
timeFrame: Assessed online daily during randomized baseline length of 5, 10 or 15 days, 5 day treatment period, and randomized post-treatment phase of 5, 10 or 15 days of assessment
measure: Positive and Negative Affect Schedule - Serene Affect Subscale
timeFrame: Assessed online daily during randomized baseline length of 5, 10 or 15 days, 5 day treatment period, and randomized post-treatment phase of 5, 10 or 15 days of assessment
Locations:
city: Brisbane
country: Australia
facility: The University of Queensland
state: Queensland
Study officials:
References: