Mind-body Therapies for Injury-related Pain Management in Elite Athletes

NCT ID: NCT06095687

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-05

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Replicated single case experimental design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The outcome assessor will be blind to participant condition.

Study Groups

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Mindfulness Meditation

Condition 1, Mindfulness Meditation (MM): The MM recording will be adapted from Day (2017). It will first instruct the listener to anchor attention on the breath while being mindfully aware of any physical sensations that arise throughout the body. The listener is then encouraged to explore sensations with non-judgmental attentiveness, without attempts to change the sensation in any way. This will implicitly provide training in mindful acceptance. Finally, the listener is instructed to simply label any thinking that arises as "thinking", before returning to the object of the meditation.

Group Type ACTIVE_COMPARATOR

Mindfulness Meditation

Intervention Type BEHAVIORAL

Five, 20-minute audio-recorded training sessions of mindfulness of breath and body meditation, practiced over consecutive days, delivered remotely via Qualtrics.

Clinical Hypnosis

Condition 2, Clinical Hypnosis (HYP): The HYP recording will be adapted from Jensen (2011). It will take the listener through a standardised self-hypnosis practice that includes an induction, followed by tailored suggestions. Specifically, the HYP session aims to take the listener through four basic ideas: 1) an induction to get the individual into a state of readiness to accept new ideas; 2) instructions to go to a favourite place to deepen the induction and provide a context for feeling heat while being relaxed; 3) linking suggestions for reducing automatic behavioural inhibition system and behavioural activation system (BIS-BAS) activation in response to stressors and enhancing awareness of when to activate each system; 4) suggestions that target enhancing self-confidence in pain management, well-being and the rehabilitation process; and 5) alerting.

Group Type ACTIVE_COMPARATOR

Clinical Hypnosis

Intervention Type BEHAVIORAL

Five, 20-minute audio-recorded training sessions of clinical hypnosis with suggestions targeting pain management, practiced over consecutive days, delivered remotely via Qualtrics.

Interventions

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Mindfulness Meditation

Five, 20-minute audio-recorded training sessions of mindfulness of breath and body meditation, practiced over consecutive days, delivered remotely via Qualtrics.

Intervention Type BEHAVIORAL

Clinical Hypnosis

Five, 20-minute audio-recorded training sessions of clinical hypnosis with suggestions targeting pain management, practiced over consecutive days, delivered remotely via Qualtrics.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama, Tuscaloosa

OTHER

Sponsor Role collaborator

The University of Queensland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Queensland

Brisbane, Queensland, Australia

Site Status

Countries

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Australia

Other Identifiers

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UniQueensland

Identifier Type: -

Identifier Source: org_study_id

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