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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT06095687
Ethics application status
Date submitted
11/10/2023
Date registered
23/10/2023

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
BEHAVIORAL - Mindfulness Meditation
BEHAVIORAL - 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.


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.

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 code [1] 0 0
BEHAVIORAL
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
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
5/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
Accrual to date
Final
0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
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.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06095687