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

NCT06095687 | Withdrawn

• 1 other identifier: UniQueensland
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Keywords

Mindfulness meditation; Clinical hypnosis; Elite athletes

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (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

Other Outcomes (2)

• 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

• 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

Study Arms (2)

Mindfulness Meditation

ACTIVE COMPARATOR

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

Clinical Hypnosis

ACTIVE COMPARATOR

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

Interventions

Mindfulness Meditation BEHAVIORAL

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

Mindfulness Meditation

Clinical Hypnosis BEHAVIORAL

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

Clinical Hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• The University of Queensland: lead
• University of Alabama, Tuscaloosa: collaborator

Study Sites (1)

The University of Queensland

Brisbane, Queensland, 4072, Australia

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Mindfulness; Hypnosis

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blind to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Replicated single case experimental design

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 23, 2023
• Study Start: May 5, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 10, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)