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

Sponsor
The University of Queensland (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06095687
Collaborator
University of Alabama, Tuscaloosa (Other)
18
1
2
14
1.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness Meditation
  • Behavioral: Clinical Hypnosis
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Replicated single case experimental designReplicated single case experimental design
Masking:
Single (Outcomes Assessor)
Masking Description:
The outcome assessor will be blind to participant condition.
Primary Purpose:
Treatment
Official Title:
Investigating the Effectiveness of Mindfulness Meditation and Clinical Hypnosis for Injury-related Pain Management in Elite Athletes
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Numerical Rating Scale (NRS) of Current Pain Intensity [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]

    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

  1. Numerical Rating Scale (NRS) of Current Pain Unpleasantness [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]

    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.

Other Outcome Measures

  1. Depression Anxiety Stress Scale, 9-item SF, Stress Subscale [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]

    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).

  2. Positive and Negative Affect Schedule - Serene Affect Subscale [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]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Queensland Brisbane Queensland Australia 4072

Sponsors and Collaborators

  • The University of Queensland
  • University of Alabama, Tuscaloosa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The University of Queensland
ClinicalTrials.gov Identifier:
NCT06095687
Other Study ID Numbers:
  • UniQueensland
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The University of Queensland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023