Home » Trials » SLCTR/2019/023
Voice disorders and the effectiveness of a behavioural change intervention to improve functional voice disorders among primary school teachers in the Colombo District
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SLCTR Registration Number
SLCTR/2019/023
Date of Registration
The date of last modification
Dec 28, 2022
Trial Status
Scientific Title of Trial
Voice disorders and the effectiveness of a behavioural change intervention to improve functional voice disorders among primary school teachers in the Colombo District
Public Title of Trial
Voice disorders and the effectiveness of a behavioural change intervention to improve functional voice disorders among primary school teachers in the Colombo District
Disease or Health Condition(s) Studied
Voice disorders
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1227-2786
Any other number(s) assigned to the trial and issuing authority
EC/19/008: ERC Colombo
What is the research question being addressed?
Can an intervention which includes lectures, interactive discussions and practical therapy activities targeted for behaviour change to develop favourable voice production, be practiced over a period of 8 weeks and improve functional voice disorders among primary school teachers?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting – A primary public school with a minimum of 10 teachers. Schools will be selected from all categories of schools with a primary section.
Method of randomization: A total of 20 clusters will be identified. Each cluster containing 10 teachers with functional voice disorders.
The intervention will be delivered by a team comprising, the Consultant ENT surgeon and Speech therapist. The group would consist of a maximum of 40 teachers. The intervention would be delivered in the Sinhala Language. The duration of the entire intervention will be 3 hours. It would be delivered only once to the teachers. It would be conducted at an auditorium. Components of the intervention are as follows 1. Understanding voice production 2. Understanding voice disorders 3. Improving physical and emotional health 4. Reducing harmful effects to voice 5. Effective voice techniques
At the end of the intervention the teachers will be provided a booklet which includes the summary of the intervention with the important tips to remember and the therapy activities that they have to practice daily. Short video clips of the therapy activities to be practiced would be shared via viber/whatsapp with teachers or by a CD (for those who do not have the facility) to remind the important points.
The baseline of both the intervention and control arms would be assessed by the validated and translated Voice Handicap Index (VHI) and short questionnaire. At the end of 8 weeks both arms would be assessed by the same questionnaires once again.
Inclusion criteria
A primary school teacher either male or female between 20 – 60 years of age who are permanent staff with a minimum of 1 year experience in teaching.
Fulfills the criteria for having functional voice disorders (defined clinically and by flexible laryngoscopy).
Engaged in normal duties for an entire term without a break or long leave
Exclusion criteria
A primary school teacher diagnosed with hearing disorders
A primary school teacher diagnosed with mental disorder
A primary school teacher pregnant or planning long leave
A primary school teacher already taking treatment for voice disorders
Primary outcome(s)
|
1.
Improvement in voice disorders - Assessed by the level of voice related handicap by the translated culturally adapted and validated Voice Handicap Index (VHI 30) questionnaire. |
[ The assessment will be done before the intervention and at 8 weeks following intervention. ] |
|
2.
Improvement in the knowledge on voice disorders and improvement in the health seeking behaviour - Assessed by a short short questionnaire consisting of knowledge on voice disorders and health seeking behaviour. |
[ The assessment will be done before the intervention and at 8 weeks following intervention. ] |
Secondary outcome(s)
|
1.
None |
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Target number/sample size
200 (100 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-07-10
Anticipated end date
2019-09-04
Date of first enrollment
2019-07-10
Date of study completion
2020-03-30
Recruitment status
Complete: follow up complete
Funding source
Pending
Regulatory approvals
N/A
Status
Approved
Date of Approval
2019-01-17
Approval number
EC/19/008
Details of Ethics Review Committee
| Name: | Ethics review committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | Faculty of Medicine, University of Colombo, Colombo |
| Telephone: | 112695300 ext 240 |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. M.D. Herath
Registrar in Community Medicine
Postgraduate Institute of Medicine, University of Colombo, Colombo
0773582827
herathmd@gmail.com
Contact Person for Public Queries
Prof. Upul Senarath
Professor in Community Medicine
Department of Community Medicine,
Faculty of Medicine, Colombo
0715773625
upul@commed.cmb.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Yes
Protocol version and date
Version 1, December 2018
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
2020-03-30
Final sample size
Date of first publication
Link to results
Brief summary of results
