Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000407594
Ethics application status
Approved
Date submitted
13/03/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effectiveness of mindfulness meditation and clinical hypnosis for injury-related pain management in competitive athletes: A replicated single-case experimental design
Scientific title
Investigating the effectiveness of mindfulness meditation and clinical hypnosis for injury-related pain management in competitive athletes: A replicated single-case experimental design
Secondary ID [1] 311731 0
nil
Universal Trial Number (UTN)
U1111-1305-5013
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain, Acute 333214 0
Condition category
Condition code
Injuries and Accidents 329901 329901 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two brief interventions (described below) being compared comprise five training sessions of 20 minutes in length, delivered across five consecutive days. Athletes are randomised to condition and will only receive one of the two trainings. The training sessions will be delivered as audio recordings via Qualtrics so that athletes can listen to the recordings (via headphones) in a location of their choice. Participants can choose to listen to the recordings either in a seated, lying down or even standing position, whatever is most comfortable to them. Participants will also have access to the recordings during the post-training maintenance period. The length of the baseline period and maintenance period will be randomly assigned as either 5-days, 10-days, or 15-days in length such that the total duration of participation for all participants totals 25 days. The treatment period immediately follows the last day of baseline monitoring, and the maintenance period immediately follows the last day of treatment. Adherence will be tracked by the researchers via a function on Qualtrics. Both interventions will be recorded by A/Prof Melissa Day, a endorsed Clinical and Health Psychologist, with the same recording listened to by participants in each condition on each day of treatment and following treatment.

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.
Intervention code [1] 328192 0
Behaviour
Comparator / control treatment
The study design is a replicated single-cased experimental design. Thus, each participant will serve as their own in-person control as they will undertake a randomised baseline self-monitoring phase, followed by introduction of the intervention phase (MM or HYP), with a subsequent randomised maintenance period following the intervention phase. The trajectories of outcome and mechanism change will also be visually inspected across MM vs HYP.
Control group
Active

Outcomes
Primary outcome [1] 337669 0
Pain intensity
Timepoint [1] 337669 0
Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days).
Primary outcome [2] 337670 0
Pain Unpleasantness
Timepoint [2] 337670 0
Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days).
Secondary outcome [1] 432752 0
Stress
Timepoint [1] 432752 0
Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days).
Secondary outcome [2] 432753 0
Fear
Timepoint [2] 432753 0
Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [3] 432755 0
Fatigue
Timepoint [3] 432755 0
Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [4] 432757 0
Serenity
Timepoint [4] 432757 0
Assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [5] 432758 0
Decentring
Timepoint [5] 432758 0
A theorised mechanism, assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [6] 432759 0
Pain catastrophizing
Timepoint [6] 432759 0
A theorised mechanism, assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [7] 432760 0
Pain coping self-efficacy
Timepoint [7] 432760 0
A theorised mechanism, assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)
Secondary outcome [8] 432761 0
Pain beliefs
Timepoint [8] 432761 0
A theorised mechanism, assessed daily during the randomised baseline period (5-15 days), during treatment (5 days), and in the randomised maintenance phase (5-15 days)

Eligibility
Key inclusion criteria
a) be a competitive athlete (i.e., compete at a level beyond recreational or casual participation. This includes athletes who participate in regional, national, or international competitions, and those who are members of competitive teams or clubs),
b) 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
c) be 18 years of age or over,
d) read, speak, and understand the English language,
e) have access to the internet on a computer or smartphone,
f) have access to a set of earphones,
g) be willing to be randomly assigned to both conditions and listen to five 20-minute treatment sessions (one per day),
h) be willing to participate in a brief 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
a) Current alcohol or substance dependence;
b) Pain condition for which surgery has been recommended and is planned;
c) Current or past participation in a research study with treatment components that may overlap those in the current study;
d) Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years;
e) Psychiatric hospitalization within the past 6 months;
f) Psychiatric or behavioural conditions in which symptoms were unstable or severe within the past 6 months;
g) Active malignancy (e.g., cancer not in remission), terminal illnesses, or serious medical conditions that may interfere with either study participation or with receiving potential treatment benefits (e.g., severe lupus).

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)
Central randomisation, by software generated randomisation plan (experimenter is blind to allocation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Replicated single case experimental design (RSCED) methodology will be implemented with embedded randomisation, replication, and a concurrent multiple-baseline across participants (A-B design + maintenance). In this design, A is the baseline, B is the intervention, and maintenance is the follow-up period. Data will be collected across the three phases (A-B + maintenance), with the expectation that the measures will not revert to baseline levels after the completion of the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Replicated single-case experimental design.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316062 0
University
Name [1] 316062 0
The University of Queensland
Country [1] 316062 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 318228 0
None
Name [1] 318228 0
Address [1] 318228 0
Country [1] 318228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314881 0
The University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 314881 0
Ethics committee country [1] 314881 0
Australia
Date submitted for ethics approval [1] 314881 0
30/06/2023
Approval date [1] 314881 0
03/07/2023
Ethics approval number [1] 314881 0
2023/HE000360

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133042 0
A/Prof Melissa Day, PhD
Address 133042 0
330 McElwain Building, The University of Queensland, Brisbane, 4072, QLD
Country 133042 0
Australia
Phone 133042 0
+61 7 3365 6421
Fax 133042 0
Email 133042 0
[email protected]
Contact person for public queries
Name 133043 0
Ms Nicole Rickerby
Address 133043 0
330 McElwain Building, The University of Queensland, Brisbane, 4072, QLD
Country 133043 0
Australia
Phone 133043 0
+61 7 3365 6421
Fax 133043 0
Email 133043 0
[email protected]
Contact person for scientific queries
Name 133044 0
Ms Nicole Rickerby
Address 133044 0
330 McElwain Building, The University of Queensland, Brisbane, 4072, QLD
Country 133044 0
Australia
Phone 133044 0
+61 7 3365 6421
Fax 133044 0
Email 133044 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.