The effectiveness of a voice care program versus no intervention in the reduction of voice handicap scores among primary school teachers in a Kota Bharu, Kelantan.
Objectives: This study was aimed to determine the effectiveness of a voice care program among primary school teachers in a northeastern district in Malaysia.
Methodology: This was a cluster randomized controlled trial that was conducted in eight randomly selected primary schools in Kota Bharu, Kelantan, Malaysia. The self-administered and validated Malay-Voice Handicap Index-10 (M-VHI-10) questionnaire was used to assess overall voice handicap scores pre and eight weeks post intervention. Teachers with a score of five or more (n=86) were randomized into intervention (n=41) and control groups (n=45) by schools. The intervention group received portable voice amplifiers and vocal hygiene instruction that was delivered by lectures and a booklet. The control group was not prescribed any intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081335655N1
Registration date:2017-10-03, 1396/07/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-03, 1396/07/11
Registrant information
Name
Esther Sundram
Name of organization / entity
Universiti Sains Malaysia
Country
Malaysia
Phone
+6097673000
Email address
ers14_dkpp005@student.usm.my
Recruitment status
Recruitment complete
Funding source
Universiti Sains Malaysia (Grant no: 304/PPSP/61313199)
Expected recruitment start date
2016-04-01, 1395/01/13
Expected recruitment end date
2016-06-30, 1395/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a voice care program versus no intervention in the reduction of voice handicap scores among primary school teachers in a Kota Bharu, Kelantan.
Public title
The effectiveness of a voice care program among primary school teachers in a Kota Bharu, Kelantan.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion Criterion:
Primary school teachers with M-VHI-10 score of five and above
Exclusion criteria:
Teachers under Otorhinolaryngology (ORL) follow up; Teachers who use voice amplifiers for teaching
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
85
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
cluster randomized controlled trial (cluster-RCT)
Secondary Ids
1
Registry name
Human Research Ethics Universiti Sains Malaysia
Secondary trial Id
USM/JEPeM/15040149
Registration date
2015-07-13, 1394/04/22
2
Registry name
Malaysian Ministry of Education
Secondary trial Id
KP(BPPDP)603/5/JLD.06(295)
Registration date
2015-08-12, 1394/05/21
Ethics committees
1
Ethics committee
Name of ethics committee
Human Research Ethics Committee, Universiti Sains Malaysia
Street address
Universiti Sains Malaysia
City
Kubang Kerian
Postal code
16150
Approval date
2015-07-13, 1394/04/22
Ethics committee reference number
USM/JEPeM/15040149
Health conditions studied
1
Description of health condition studied
Voice problems
ICD-10 code
R49
ICD-10 code description
Voice disturbances
Primary outcomes
1
Description
Malay Voice Handicap Index 10 (M-VHI-10) score
Timepoint
Pre and post intervention at 8 weeks
Method of measurement
Malay Voice Handicap Index 10 (M-VHI-10) questionnaire
Secondary outcomes
1
Description
Functional, Physical and Emotional Domain Scores
Timepoint
Pre and Post Functional, Physical and Emotional Domain Scores
Method of measurement
Malay Voice Handicap Index-10 Questionnaire
Intervention groups
1
Description
Control:
Teachers with a score of five or more (n=86) were randomized into 2 groups by schools. The intervention group (n=45) comprised of four schools.
This control group was not prescribed with any intervention.
Category
Other
2
Description
Intervention:
Teachers with a score of five or more (n=86) were randomized into 2 groups by schools. The intervention group (n=41) comprised of four schools.
This group received the voice care program: portable voice amplifiers and vocal hygiene instruction that was delivered by lectures and a booklet.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Primary Schools, Malaysian Ministry of Education
Full name of responsible person
Che Hanuni Bt Che Ali
Street address
Jabatan Pendidikan Negeri Kelantan, Bandar Baru Tunjong,
City
Kota Bharu
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Universiti Sains Malaysia
Full name of responsible person
Nik Rosmawati Nik Husain
Street address
Universiti Sains Malaysia
City
Kubang Kerian
Grant name
Grant code / Reference number
304/PPSP/61313199
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Universiti Sains Malaysia
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Universiti Sains Malaysia
Full name of responsible person
Esther Sundram
Position
Doctorate in Public Health
Other areas of specialty/work
Street address
Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia
City
Kubang Kerian
Province
Kelantan
Postal code
16150
Phone
00
Fax
Email
estherishma@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Universiti Sains Malaysia
Full name of responsible person
Dr Nazri Bin Shafei
Position
Senior Medical Lecturer, Master of Community Medicine
Other areas of specialty/work
Street address
Department of Community Medicine, School of Medical Sciences, Universiti Sains Malaysia
City
Kubang Kerian
Province
Kelantan
Postal code
16150
Phone
00
Fax
Email
drnazri@usm.my
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Universiti Sains Malaysia
Full name of responsible person
Esther Sundram
Position
Doctorate of Public Health
Other areas of specialty/work
Street address
Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia
City
Kubang Kerian
Province
Kelantan
Postal code
16150
Phone
00
Fax
Email
estherishma@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)