| CTRI Number |
CTRI/2020/04/024759 [Registered on: 21/04/2020] Trial Registered Prospectively |
| Last Modified On: |
15/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Voice Therapy Using Video Conferencing |
|
Scientific Title of Study
|
Influence of Televoice Therapy Program on Vocal Parameters for Individuals with Vocal Nodules |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandini B Nair |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing
Manipal College of Health Professions
Manipal Academy of Higher Educations
Madhav Nagar
Manipal
Udupi
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9496414036 |
| Fax |
|
| Email |
chandininrlm96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Devadas |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing
Manipal College of Health Professions
Manipal Academy of Higher Educations
Madhav Nagar
Manipal
Udupi
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448930882 |
| Fax |
|
| Email |
usha.d@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Devadas |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Speech and Hearing
Manipal College of Health Professions
Manipal Academy of Higher Educations
Madhav Nagar
Manipal
Udupi
Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9448930882 |
| Fax |
|
| Email |
usha.d@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Educations,Manipal, 576104 |
|
|
Primary Sponsor
|
| Name |
Chandini B Nair |
| Address |
Department of Speech and Hearing
Manipal College of Health Professions
Manipal Academy of Higher Educations
Madhav Nagar
Manipal
Udupi
Karnataka
576104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Chandini B Nair |
Kasturba Hospital |
Department of Speech and Hearing
Manipal College of Health Professions
Manipal Academy of Higher Educations
Madhav Nagar
Manipal
576104
Udupi
Karnataka
Udupi
KARNATAKA |
9496414036
chandininrlm96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R490||Dysphonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Tele voice therapy |
8 alternate voice therapy sessions provided via Zoom software in android mobile phones for 30 minutes and comparing pre and post assessment results |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
a) Who are diagnosed to have early vocal nodule by an Otolaryngologist and are referred for voice therapy
b) Who are not able to attend face-to-face voice therapy due to distance or occupation related things
|
|
| ExclusionCriteria |
| Details |
a) Individuals diagnosed with other vocal pathologies related to hyper-functional voice use (vocal polyps, vocal cyst)
b) Having other associated problems like resonance, articulation, allergic rhinitis, respiratory disorders, hearing loss, psychiatric or neurologic conditions
c) Participants who have undergone vocal fold surgery
d) Have attended voice therapy previously
e) Have no access to a smartphone which is compatible to download ZOOM software
f) Who does not have an internet package of 2-3 Mb/s
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Auditory perceptual evaluation score
2)Acoustic analysis result
3)Aerodynamic evaluation result
4)Self perceptual ealuation score
|
April 2020 to March 2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Participnt satisfaction |
April 2020 to March 2021 |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim To investigate the influence of tele voice therapy program on vocal parameters of individuals with vocal nodule Objectives 1) To investigate the influence of tele voice therapy program on vocal parameters of individuals with vocal nodule 2) To investigate the feasibility and participants perception about voice therapy delivered through telepractice Justification for study In India, speech therapy services are available in very few centres and people from rural and remote areas face the challenge to get such services. Hence, there is a need to explore the feasibility and influence of telerehabilitation in this context which can prove to be a great help for society. |