Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000240448
Ethics application status
Approved
Date submitted
4/02/2025
Date registered
3/04/2025
Date last updated
3/04/2025
Date data sharing statement initially provided
3/04/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating The Effectiveness of Transcendental Meditation Technique on Resilience and General Well-being of Paramedicine Students – A Randomised Controlled Pilot Study
Scientific title
Evaluating The Effectiveness of Transcendental Meditation Technique on Resilience and General Well-being of Paramedicine Students – A Randomised Controlled Pilot Study
Secondary ID [1] 313880 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resilience 336549 0
Well-being 336550 0
Condition category
Condition code
Mental Health 333066 333066 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pilot randomised control trial (RCT) spanning 4 weeks assessed the efficacy of Transcendental Meditation (TM) on paramedicine students (n=5) compared to a control group (n=5). A set of questionnaires were distributed pre- and post-intervention to determine the effect of TM.
The questionnaires included: Depression Anxiety Stress Scale 21 (DASS-21), Insomnia Severity Index (ISI), 14-item Trait Resilience Questionnaire (RS-14), and Ego Resilience Questionnaire (ER-89).
The TM technique was taught by professional TM instructors. It involved sitting quietly twice daily for 20 minutes for 4 weeks, practicing an assigned mantra that was given by their instructor.
The instruction was given one on one over a 4 day period. Session attendance was followed up post study.
Intervention code [1] 330469 0
Prevention
Comparator / control treatment
The RCT had two groups, a TM intervention group, and control group who followed normal health and well-being pathways as a student at Griffith University. This included access to current mental health facilities and counselling services on campus or online. Due to this study design, blinding will not be possible for the participants. However, the lead investigator will be blinded to which group is the intervention or control.
Control group
Active

Outcomes
Primary outcome [1] 340602 0
Resilience
Timepoint [1] 340602 0
Baseline and 4-weeks post-intervention
Primary outcome [2] 340603 0
Well-being
Timepoint [2] 340603 0
Baseline and 4-weeks post-intervention
Secondary outcome [1] 444565 0
Depression
Timepoint [1] 444565 0
Baseline and 4-weeks post-intervention
Secondary outcome [2] 444566 0
Anxiety
Timepoint [2] 444566 0
Baseline and 4-weeks post-intervention
Secondary outcome [3] 444567 0
Stress
Timepoint [3] 444567 0
Baseline and 4-weeks post-intervention
Secondary outcome [4] 444568 0
Insomnia
Timepoint [4] 444568 0
Baseline and 4-weeks post-intervention

Eligibility
Key inclusion criteria
Inclusion Criteria: paramedicine students, living in Gold Coast or Brisbane, Australia, could commit and adhere to intervention or control schedule, capable of providing informed consent, can speak and read English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria: students could not already be practicing TM, have a serious psychiatric condition such as schizophrenia or bipolar disorder, or be taking illicit drugs.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants underwent simple randomisation at a ratio of 1:1 to participate in either the intervention or control group. Matching of participants between groups using gender and year of study ensued.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To determine the ideal sample size of this pilot study, the G*Power (latest ver. 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany) software was used to conduct a priori power analysis. The aspects entered into the G*Power software included one-tailed hypothesis, alpha error probability of 5% type 1 error, a power of 0.80, allocation ratio of 1, and Cohen’s d large effect size (d) of 0.80 as field-specific estimates were unknown. This resulted in an estimated sample size of 42, with 21 in the intervention and 21 in the control group. With an allowance of 20% for attrition, incomplete data, or dropouts, the total would be estimated at 50 with 25 students in each group. However, due to time, funding, and recruitment constraints, this was not achieved, hence this became a pilot study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/10/2022
Date of last participant enrolment
Anticipated
Actual
3/10/2022
Date of last data collection
Anticipated
Actual
7/11/2022
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 43686 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 318351 0
University
Name [1] 318351 0
Griffith University
Country [1] 318351 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 320752 0
None
Name [1] 320752 0
Address [1] 320752 0
Country [1] 320752 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316982 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316982 0
Ethics committee country [1] 316982 0
Australia
Date submitted for ethics approval [1] 316982 0
04/08/2022
Approval date [1] 316982 0
26/08/2022
Ethics approval number [1] 316982 0
GU Ref No: 2022/628

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

Contacts
Principal investigator
Name 139646 0
Ms Abbie Little
Address 139646 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 139646 0
Australia
Phone 139646 0
+61417128159
Fax 139646 0
Email 139646 0
[email protected]
Contact person for public queries
Name 139647 0
Abbie Little
Address 139647 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 139647 0
Australia
Phone 139647 0
+61417128159
Fax 139647 0
Email 139647 0
[email protected]
Contact person for scientific queries
Name 139648 0
Abbie Little
Address 139648 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 139648 0
Australia
Phone 139648 0
+61417128159
Fax 139648 0
Email 139648 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• Raw de-identified data

What types of analyses could be done with individual participant data?
• IPD meta-analyses

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator via email at [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.