Home » Trials » SLCTR/2017/004
Efficacy of voice therapy for vocal fold nodules in women
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SLCTR Registration Number
SLCTR/2017/004
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Efficacy of voice therapy for vocal fold nodules in women
Public Title of Trial
Efficacy of voice therapy for vocal fold nodules in women
Disease or Health Condition(s) Studied
Vocal fold nodules
Scientific Acronym
None
Public Acronym
None
Brief title
Efficacy of voice therapy for vocal fold nodules in women
Universal Trial Number
U1111-1193-5997
Any other number(s) assigned to the trial and issuing authority
P/207/12/2016 (ERC: Kelaniya)
What is the research question being addressed?
Is the combined approach of vocal hygiene education and voice production intervention more effective than no intervention in the treatment of vocal fold nodules in women?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Other
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
The study will take place at the following study sites:
ENT clinic of the Jaffna Teaching Hospital
National Hospital of Sri Lanka North Colombo Teaching Hospital (Ragama)
Vavuniya General Hospital
Trincomalee General Hospital
Batticaloa General Hospital
Private hospitals in Colombo district and suburbs.
Participants will be recruited from the clinical practices and referrals of ENT surgeons of the Jaffna Teaching Hospital. All participants will have to be recommended for voice therapy as the first modality of treatment.
Depending on the standard practice of the unit, patients may be assigned to receive therapy, or wait-listed.
Those selected for therapy will form the intervention group. Matched controls will be identified from the wait-listed patients.
The intervention group will receive six consecutive weekly 45-min sessions of voice therapy and vocal cord hygiene education. The intervention will be provided by a clinician/therapist who has been working with similar clients as the target population for a significant period of time. The control group will be offered treatment after the waiting period according to standard clinic practice.
Outcomes will be assessed by independent therapists who will be blinded to the treatment status of the participants.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Auditory perceptual voice quality ratings by two experienced therapists using the Consensus Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) (Kempster et al., 2009). |
[ At baseline and six weeks after the commencement of the intervention ] |
Secondary outcome(s)
|
1.
Vocal fold status (as assessed by indirect laryngoscopy) |
[ At baseline and six weeks after the commencement of the intervention ] |
|
2.
Self-assessment of voice quality (Voice Symptom Scale – VoiSS, Deary et al., 2003). |
[ At baseline and six weeks after the commencement of the intervention ] |
Target number/sample size
64 (32 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-03-03
Anticipated end date
2017-09-30
Date of first enrollment
2017-04-21
Date of study completion
Recruitment status
Recruiting
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-12-06
Approval number
P/207/12/2016
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Gayithri Sivasubramaniam
Lecturer (Probationary)
Department of Disability Studies, Faculty of Medicine, University of Kelaniya, Sri Lanka.
Tel: 0112958251
Mob: 0714866199
gayithrissm@yahoo.com
Contact Person for Public Queries
Professor A.Pathmeswaran
Professor
Department of Public Health,
Faculty of Medicine, University of Kelaniya,
Sri Lanka.
Tel:0112953411
Mob: 0776726762
pathmes@gmail.com
Primary study sponsor/organization
Department of Disability Studies, Faculty of Medicine, University of Kelaniya.
Faculty of Medicine, University of Kelaniya.
Sri Lanka
Tel:0112958251
Fax:0112958251
http://medicine.kln.ac.lk/depts/dds/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
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
