Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
821007
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Voice disorders
Intervention
Patients will be randomly assigned to either the treatment or non-treatment group:
1. Treatment group: each subject in the treatment group will receive a structured voice therapy programme individually. The program consists of 10 weekly sessions involving vocal hygiene education and vocal exercises
2. Control group: the non-treatment group will receive no therapy for 10 weeks before being given voice therapy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1998
Overall trial end date
01/01/2001
Reason abandoned
Eligibility
Participant inclusion criteria
1. Subjects with voice disorders should have one of the following pathologies:
1.1. Vocal nodule
1.2. Vocal polyp
1.3. Cysts
1.4. Chronic laryngitis
1.5. Odema
2. Must have normal hearing
3. Aged between 21 to 50 years old
4. Must be non-smokers
5. Consume less than one standard alcohol drink a day
6. Had not received any voice therapy
7. Not professional voice users (e.g., singers, actors, etc)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/1998
Recruitment end date
01/01/2001
Locations
Countries of recruitment
Hong Kong
Trial participating centre
Department of Speech & Hearing Sciences
-
-
Hong Kong
Sponsor information
Organisation
Hong Kong Health Services Research Fund (Hong Kong)
Sponsor details
Health Welfare and Food Bureau
Government Secretariat
HKSAR
20th floor Murray Building
Garden Road
-
-
Hong Kong
+852 (0)2973 8288
hsrf@hwfb.gov.hk
Sponsor type
Government
Website
http://www.fhb.gov.hk/grants/english/funds/funds_hhsrf/funds_hhsrf_abt/funds_hhsrf_abt.html
Funders
Funder type
Government
Funder name
Hong Kong Health Services Research Fund (Hong Kong)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary