Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06095687




Registration number
NCT06095687
Ethics application status
Date submitted
11/10/2023
Date registered
23/10/2023
Date last updated
4/12/2023

Titles & IDs
Public title
Mind-body Therapies for Injury-related Pain Management in Elite Athletes
Scientific title
Investigating the Effectiveness of Mindfulness Meditation and Clinical Hypnosis for Injury-related Pain Management in Elite Athletes
Secondary ID [1] 0 0
UniQueensland
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Acute 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Mindfulness Meditation
Behaviour - Clinical Hypnosis

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.

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.


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

Behaviour: 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 code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Numerical Rating Scale (NRS) of Current Pain Intensity
Timepoint [1] 0 0
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 [1] 0 0
Numerical Rating Scale (NRS) of Current Pain Unpleasantness
Timepoint [1] 0 0
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

Eligibility
Key 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 age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
18/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
The University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Alabama, Tuscaloosa
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06095687
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Melissa Day, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 7 3365 6421
Fax 0 0
Email 0 0
m.day@uq.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06095687