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

Primary Purpose

Pain, Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Mindfulness Meditation
Clinical Hypnosis
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring Mindfulness meditation, Clinical hypnosis, Elite athletes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Queensland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mindfulness Meditation

Clinical Hypnosis

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numerical Rating Scale (NRS) of Current Pain Intensity
Change in pain intensity will be measured using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity.

Secondary Outcome Measures

Numerical Rating Scale (NRS) of Current Pain Unpleasantness
Change in pain unpleasantness will be measured using a 0-10 numerical rating scale (NRS) of average pain unpleasantness in the past 24 hours. Participants will be asked to choose a number from 0-10 that best represents their pain unpleasantness. Higher scores indicate higher levels of self-reported pain unpleasantness.

Full Information

First Posted
October 11, 2023
Last Updated
October 17, 2023
Sponsor
The University of Queensland
Collaborators
University of Alabama, Tuscaloosa
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1. Study Identification

Unique Protocol Identification Number
NCT06095687
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Queensland
Collaborators
University of Alabama, Tuscaloosa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
Mindfulness meditation, Clinical hypnosis, Elite athletes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Replicated single case experimental design
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blind to participant condition.
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Meditation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Clinical Hypnosis
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation
Intervention Description
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
Intervention Name(s)
Clinical Hypnosis
Intervention Description
Five, 20-minute audio-recorded training sessions of clinical hypnosis with suggestions targeting pain management, practiced over consecutive days, delivered remotely via Qualtrics.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) of Current Pain Intensity
Description
Change in pain intensity will be measured using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity.
Time Frame
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 Outcome Measure Information:
Title
Numerical Rating Scale (NRS) of Current Pain Unpleasantness
Description
Change in pain unpleasantness will be measured using a 0-10 numerical rating scale (NRS) of average pain unpleasantness in the past 24 hours. Participants will be asked to choose a number from 0-10 that best represents their pain unpleasantness. Higher scores indicate higher levels of self-reported pain unpleasantness.
Time Frame
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 Pre-specified Outcome Measures:
Title
Depression Anxiety Stress Scale, 9-item SF, Stress Subscale
Description
Change in general stress will be measured, with participants indicating how often they experience certain stress responses on a scale from 0 (never) to 3 (almost always).
Time Frame
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
Title
Positive and Negative Affect Schedule - Serene Affect Subscale
Description
Change in serene affect will be measured with participants rating three adjectives describing serenity affect (i.e., relaxed, at ease, calm) on a 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely).
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Day, PhD
Phone
+61 7 3365 6421
Email
m.day@uq.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Rickerby, MCR
Email
uqnricke@uq.edu.au
Facility Information:
Facility Name
The University of Queensland
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4072
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate data will be made available for research purposes upon reasonable request once the data are published (within a time period of 5-years), with a data sharing agreement put in place.

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

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