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

10 Jul 2019

The date of last modification

Jul 10, 2019



Application Summary


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


Trial Details


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.

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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


Date of study completion


Recruitment status

Pending


Funding source

Pending


Regulatory approvals

N/A



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





Trial Completion details


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


Final sample size


Date of first publication


Link to results


Brief summary of results