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Trial registered on ANZCTR
Registration number
ACTRN12626000975392
Ethics application status
Approved
Date submitted
10/07/2026
Date registered
7/08/2026
Date last updated
7/08/2026
Date data sharing statement initially provided
7/08/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Can Adding Mindfulness Training to a Voice Care Programme Improve Vocal Fatigue and Voice Health in University Teaching Staff? A Pilot Randomised Controlled Trial
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Scientific title
Evaluating the Feasibility and Preliminary Effectiveness of Supplementing a Voice Care Programme with a Mindfulness-Based Intervention for Improving Vocal Fatigue and Voice Quality in University Teaching Staff: A Pilot Parallel-Group Randomised Controlled Trial
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Additional trial identifiers [1]
317656
0
Nil known
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Universal Trial Number (UTN)
U1111-1342-7773
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
vocal fatigue
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Occupational voice problems
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Condition category
Condition code
Public Health
338598
338598
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0
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Health promotion/education
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Oral and Gastrointestinal
339109
339109
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
Participants allocated to the intervention group will receive a structured mindfulness-based intervention in addition to the standard Voice Care Program provided to both study groups.
The mindfulness intervention will commence concurrently with the Voice Care Program following completion of baseline assessments and randomisation. It consists of six face-to-face group sessions delivered over a 6-week period by an experienced mindfulness instructor. Each session is approximately 100-120 minutes in duration and includes guided mindfulness meditation practices, experiential exercises, facilitated group discussion, and instructions for home practice. The curriculum progressively develops mindfulness skills through breath awareness, focused attention, body awareness, emotional regulation, self-compassion, and the application of mindfulness to stress management and wellbeing.
Participants will be encouraged to undertake optional home mindfulness practice between sessions and will be asked to complete brief weekly practice logs to monitor adherence to home practice.
The study will be conducted at the University of Melbourne, Australia.
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Intervention code [1]
334495
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Lifestyle
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Intervention code [2]
334496
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Prevention
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Intervention code [3]
334497
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Behaviour
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Description of the comparator or control
Participants in the comparator group will receive a standard Voice Care Program, which reflects routine preventive management for professional voice users experiencing vocal fatigue. The program includes education on vocal anatomy and function, principles of vocal hygiene, hydration, vocal warm-up exercises, reduction of phonotraumatic behaviours, voice conservation strategies, and practical approaches for managing occupational vocal demands. The program will be delivered by the principal investigator, a qualified speech pathologist with clinical experience in voice disorders, through three online group sessions of approximately 45–60 minutes each, delivered fortnightly over the 6-week intervention period. Participants will also be offered optional home practice activities, which, if completed, are expected to take approximately 10 minutes per day. The comparator group will not receive the mindfulness intervention during the study period.
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Control group
Active
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Outcomes
Primary outcome [1]
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Recruitment rate
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Assessment method [1]
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Review of recruitment records to determine the proportion of participants enrolled compared with the recruitment target.
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Timepoint [1]
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At completion of recruitment (before intervention commencement)
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Primary outcome [2]
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Retention rate
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Assessment method [2]
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Proportion of randomised participants completing post-intervention and follow-up assessments.
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Timepoint [2]
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Post-intervention (Weeks 11–12 of Semester 2, 2026) and follow-up (Semester 1, 2027; primary timepoint).
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Primary outcome [3]
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Intervention adherence
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Assessment method [3]
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Attendance records and home mindfulness practice logs. Intervention adherence will be assessed as the proportion of participants attending at least 4 of the 6 mindfulness sessions and the proportion of recommended home mindfulness practice completed between sessions, based on participants' weekly practice logs.
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Timepoint [3]
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Throughout the intervention period and assessed at post-intervention (Weeks 11–12 of Semester 2, 2026).
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Secondary outcome [1]
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Acoustic Voice Quality Index (AVQI)
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Assessment method [1]
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Acoustic analysis of voice recordings using Praat software.
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Timepoint [1]
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Baseline (T1), immediately post-intervention (T2; following completion of the 6-week intervention), and follow-up (T3; approximately 6 months after completion of the intervention).
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Secondary outcome [2]
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Vocal fatigue
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Assessment method [2]
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Vocal Fatigue Index (VFI-19).
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Timepoint [2]
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Baseline (T1), immediately post-intervention (T2; following completion of the 6-week intervention), and follow-up (T3; approximately 6 months after completion of the intervention).
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Secondary outcome [3]
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Perceptual voice quality
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Assessment method [3]
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) rated by blinded assessors.
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Timepoint [3]
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Baseline (T1), immediately post-intervention (T2; following completion of the 6-week intervention), and follow-up (T3; approximately 6 months after completion of the intervention).
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Secondary outcome [4]
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Phonation Threshold Pressure (PTP)
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Assessment method [4]
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Standardised aerodynamic voice assessment.
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Timepoint [4]
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Baseline (T1), immediately post-intervention (T2; following completion of the 6-week intervention), and follow-up (T3; approximately 6 months after completion of the intervention).
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Secondary outcome [5]
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Psychological distress
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Assessment method [5]
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Kessler Psychological Distress Scale (K10).
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Timepoint [5]
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Baseline (T1), immediately post-intervention (T2; following completion of the 6-week intervention), and follow-up (T3; approximately 6 months after completion of the intervention).
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Secondary outcome [6]
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Interoceptive awareness
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Assessment method [6]
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Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2).
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Timepoint [6]
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Baseline (T1), immediately post-intervention (T2; following completion of the 6-week intervention), and follow-up (T3; approximately 6 months after completion of the intervention).
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Secondary outcome [7]
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Work-related burnout
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Assessment method [7]
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Burnout Assessment Tool – Work-Related Short Version (BAT-WS).
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Timepoint [7]
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Baseline (T1), immediately post-intervention (T2; following completion of the 6-week intervention), and follow-up (T3; approximately 6 months after completion of the intervention).
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Eligibility
Key inclusion criteria
1-Currently employed as teaching staff at the University of Melbourne (e.g. lecturer, tutor, academic staff member, or sessional teaching staff).
2-Currently undertaking teaching duties during Semester 2, 2026.
3-Score of 11 or higher on the Vocal Fatigue Index (VFI), indicating increased risk of voice disorders.
4-Limited prior meditation experience (fewer than 25 hours of meditation practice in the previous 6 months and no participation in a structured mindfulness-based intervention within the previous 10 years).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
1- Currently receiving specialist voice therapy.
2- Currently participating in a structured mindfulness-based intervention or meditation training programme.
3- Recent bereavement or a major personal loss, or severe anxiety, depression, or another serious mental or physical health condition that may affect their ability to engage with the intervention or study procedures.
4- Unable to attend intervention sessions or complete study assessments.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A member of the research team who is not involved in participant recruitment or outcome assessment will generate a computer-generated permuted block randomisation sequence with a 1:1 allocation ratio.
Another member of the research team will prepare 60 identical, opaque, sequentially numbered sealed envelopes (30 per group) according to the randomisation sequence. After a participant provides informed consent and completes all baseline assessments, the researcher responsible for participant enrolment will write the participant's study identification number on the next sequential envelope and return it to the researcher responsible for allocation. The researcher responsible for allocation will then open the envelope in the participant's presence, reveal the participant's group allocation, and record the allocation in the trial allocation log. This procedure will maintain allocation concealment until participant enrolment and completion of baseline assessments.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A member of the research team who is not involved in participant recruitment or outcome assessment will generate a computer-generated permuted block randomisation sequence with a 1:1 allocation ratio.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
A total sample of 60 participants (30 per group) was selected as appropriate for a pilot randomised controlled trial and feasible within available resources. The primary purpose of the study is to assess feasibility and acceptability, including recruitment, retention, adherence, and data completeness, and to obtain preliminary estimates of effect sizes and variability to inform the design and sample size calculation of a future definitive trial. No formal hypothesis-based power calculation was performed. Feasibility outcomes will be summarised descriptively. Preliminary effectiveness outcomes will be analysed on an exploratory basis. Between-group differences in post-intervention and follow-up outcomes will be examined using analysis of covariance (ANCOVA), adjusting for baseline values of the outcome measure. Within-group changes from baseline to post-intervention and follow-up will be explored using paired t-tests or non-parametric equivalents where assumptions for parametric analyses are not met. Effect sizes and 95% confidence intervals will be reported to estimate the magnitude and precision of intervention effects.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
12/08/2026
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Actual
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Date of last participant enrolment
Anticipated
1/09/2026
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Actual
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Date of last data collection
Anticipated
28/05/2027
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
46015
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3053 - Carlton
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Funding & Sponsors
Funding source category [1]
322199
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University
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Name [1]
322199
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Contemplative Studies Centre (CSC), Melbourne School of Psychological Sciences (MSPS)
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Address [1]
322199
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Country [1]
322199
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Australia
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Primary sponsor type
University
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Name
University of Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
325313
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None
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Name [1]
325313
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Address [1]
325313
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Country [1]
325313
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
320723
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University of Melbourne Central Human Research Ethics Committee
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Ethics committee address [1]
320723
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University of Melbourne Central Human Research Ethics Committee (HREC) Research Ethics and Integrity The University of Melbourne Parkville VIC 3010, Australia research-integrity@unimelb.edu.au
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Ethics committee country [1]
320723
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Australia
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Date submitted for ethics approval [1]
320723
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24/12/2025
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Approval date [1]
320723
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10/02/2026
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Ethics approval number [1]
320723
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34174
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Summary
Brief summary
University teaching staff are at increased risk of vocal fatigue and voice disorders due to high occupational voice demands. This pilot randomised controlled trial will evaluate the feasibility, acceptability, and preliminary effectiveness of supplementing a standard Voice Care Programme with a mindfulness-based intervention. Sixty University of Melbourne teaching staff with vocal fatigue will be randomly allocated to either a Voice Care Programme alone or a Voice Care Programme plus mindfulness intervention. Feasibility outcomes will include recruitment, retention, adherence, and participant acceptability. Preliminary effectiveness outcomes will include vocal fatigue, voice quality, phonation threshold pressure, psychological distress, interoceptive awareness, and burnout.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Fatemeh Aghaei
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Address
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Contemplative Studies Centre, Level 1, Melbourne Connect, 700 Swanston Street, Parkville VIC 3010, Australia.
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Country
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Australia
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Phone
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+61 468709702
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Fax
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Email
151418
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[email protected]
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Contact person for public queries
Name
151419
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Fatemeh Aghaei
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Address
151419
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Contemplative Studies Centre, Level 1, Melbourne Connect, 700 Swanston Street, Parkville VIC 3010, Australia.
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Country
151419
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Australia
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Phone
151419
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+61 468709702
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Fax
151419
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Email
151419
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[email protected]
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Contact person for scientific queries
Name
151420
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Fatemeh Aghaei
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Address
151420
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Contemplative Studies Centre, Level 1, Melbourne Connect, 700 Swanston Street, Parkville VIC 3010, Australia.
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Country
151420
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Australia
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Phone
151420
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+61 468709702
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Fax
151420
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Email
151420
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[email protected]
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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:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
•
De-identified individual participant data:
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Published results
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Primary outcome(s)
What types of analyses could be done with individual participant data?
•
Systematic reviews and meta-analyses
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Studies exploring new research questions
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Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
Requests for access to de-identified participant data should be submitted to the Principal Investigator via email at
[email protected]
. Requests will be reviewed on a case-by-case basis in accordance with participant consent, ethical requirements, and The University of Melbourne data governance policies.
Are there extra considerations when requesting access to individual participant data?
Yes:
Access will be limited to de-identified data only. Requests will be reviewed on a case-by-case basis by the study investigators. Data sharing must be consistent with participant consent, ethical approval conditions, and University of Melbourne data governance requirements. Voice recordings and other potentially identifiable materials will not be shared.
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Informed consent form
Consent Form.June 2026.docx
Ethical approval
Ethics approval.pdf
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.
Download to PDF