Home » Trials » SLCTR/2017/004


Efficacy of voice therapy for vocal fold nodules in women -

SLCTR Registration Number

SLCTR/2017/004


Date of Registration

03 Mar 2017

The date of last modification

May 15, 2017


Trial Status



Application Summary


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)


Trial Details


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


Assignment

Other


Purpose

Treatment


Phase


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

  1. Adult females (aged 18 years and above)
  2. Recent (within 3 months) diagnosis of vocal fold nodules by an ENT surgeon
  3. Recommendation of voice therapy as the first modality of treatment

Exclusion criteria

  1. History of neurologic disease that might contribute to the voice disorder.
  2. History of laryngeal, lower or upper airway or head and neck surgery or procedures that could affect voice production.


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. 1.Vocal fold status (as assessed by indirect laryngoscopy) 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

2017-03-03


Date of first enrollment


Date of study completion


Recruitment status

Recruiting


Funding source

None



State of Ethics Review Approval


Status


Date of Approval


Approval number


Details of Ethics Review Committee

Name:
Institutional Address:
Telephone:
Email:


Contact & Sponsor Information


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/

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description


Study protocol available


Protocol version and date


Protocol URL


Results summary available


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results