CTRI Number |
CTRI/2022/11/047256 [Registered on: 14/11/2022] Trial Registered Prospectively |
Last Modified On: |
12/11/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Other |
Public Title of Study
|
Influence Of Tele Therapy On Individuals With Hyperfunctional Voice Disorders. |
Scientific Title of Study
|
Influence Of Tele Voice Therapy Program Using Smartphones On Vocal Parameters For Individuals With Hyperfunctional Voice Disorders |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Ananya |
Designation |
Post Graduate Student |
Affiliation |
MCHP, MAHE, Manipal |
Address |
Department Of Speech And Hearing, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi District
Udupi KARNATAKA 576104 India |
Phone |
7022737235 |
Fax |
|
Email |
ananya.mcoahsma1@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
Name |
Dr Usha Devadas |
Designation |
Associate Professor and Head |
Affiliation |
MCHP, MAHE, Manipal |
Address |
Department Of Speech And Hearing, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi District.
Udupi KARNATAKA 576104 India |
Phone |
9448930882 |
Fax |
|
Email |
usha.d@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Ananya |
Designation |
Post Graduate Student |
Affiliation |
MCHP, MAHE, Manipal |
Address |
Department Of Speech And Hearing, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi District.
Udupi KARNATAKA 576104 India |
Phone |
7022737235 |
Fax |
|
Email |
ananya.mcoahsma1@learner.manipal.edu |
|
Source of Monetary or Material Support
|
Department Of Speech and Hearing, MCHP, MAHE, Manipal |
|
Primary Sponsor
|
Name |
Ananya |
Address |
Department Of Speech And Hearing, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi District. |
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 |
Ananya |
Kasturba Hospital, Manipal, |
Department Of Speech And Hearing, Room Number:416, Manipal College Of Health Professions, Manipal Academy Of Higher Education, Manipal, Udupi District. Udupi KARNATAKA |
7022737235
ananya.mcoahsma1@learner.manipal.edu |
|
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 |
The intervention will be provided through smartphones using WhatsApp messenger, for 16 sessions of therapy, 8 sessions being direct intervention sessions- which will be provided for three days in a week in an alternate manner, in which vocal exercises will be provided, and rest 8 sessions being practice sessions where the clinician monitors the exercises passively- which will be for rest three days a week. Therefore, The intervention session will be taken a day, with next day being practice session, the third day being intervention session again. The therapy will be taken in this manner for 16 days. Each session will last for 30 minutes. The outcome measures will be analyzed pre and post intervention. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
All the participants referred by Otolaryngologists, who are diagnosed with early vocal nodule and muscle tension dysphonia and are referred for voice therapy, those who cannot attend face-to-face therapy due to distance or occupation related constraints |
|
ExclusionCriteria |
Details |
Individuals diagnosed with other vocal pathologies related to hyperfunctional voice disorders(vocal polyps, vocal cysts), Having associated problems like - resonance, articulation, allergic rhinitis, respiratory disorders, hearing loss, psychiatric and neurologic conditions, Participants underwent vocal fold surgery, Have had attended voice therapy previously, Have had no access to smartphones/ internet facility. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. Auditory perceptual analysis of voice- GRBAS perceptual scale
2. Acoustic analysis
3. Maximum Phonation Duration
4. Quality of life
|
Outcome measured will be measured at baseline and post intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not Applicable |
Not Applicable |
|
Target Sample Size
|
Total Sample Size="18" Sample Size from India="18"
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
|
N/A |
Date of First Enrollment (India)
|
15/11/2022 |
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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Voice therapy appears to be an effective treatment for various hyper-functional voice disorders, particularly early vocal nodules and muscular tension dysphonia (Holmberg et al., 2003). Vocal nodules have been linked to hyper-functional/phonotraumatic voice usage in literature. Muscle Tension Dysphonia (MTD) is also caused by vocal misuse/abuse, psychiatric illnesses, and underlying organic lesions, Behavioral voice therapy strategies focus on changing certain vocal behaviors and have been shown to help people with vocal nodules improve their voice quality. However, most individuals with voice disorders were reported to drop out and fail to sustain voice therapy sessions at a higher rate. Portone et al. (2008) observed 38% of patients never returned for voice evaluation recommended by the Otolaryngologist, and 47% of patients never reported voice therapy after the voice evaluation. , when these authors studied the reasons for the dropouts, they identified distance to travel for voice therapy, especially individuals who reside in rural areas or remote areas, are not able to take time off from their work, insurance denials, and lack of confidence about voice therapy were the main reasons for the dropout. In recent years telepractice/telerehabilitation has been an effective method in delivering speech therapy for whom face-to-face contact is impossible.The majority of the studies reported positive perceptions of participants about telerehabilitation. However, this method may not reveal similar results for all types of disability. Hence, there is a need to understand the feasibility and efficacy of voice rehabilitation delivered through telepractice for individuals with voice disorders. Summary of the review Different studies were conducted to check the influence and feasibility of telepractice differently. Some of the studies compared pre-and post-therapy assessment measures, and some compared the results of tele practice with conventional mode of therapy. Most of the studies have targeted patients with Parkinson’s diseas/e. Some studies shed light on vocal nodules, muscle tension dysphonia, hyper-functional voice disorders, edema, and unilateral vocal fold paralysis. Most of the studies delivered voice therapy using Skype video calling. However, all the existing studies have reported positive participant perception irrespective of the mode of delivery. Research gap Minimal evidence exists regarding the feasibility of tele practice delivered using smartphones. To date, minimal data exists to understand the feasibility and influence of voice therapy delivered through tele practice for individuals with voice disorders in India. Need for the study Dysphonia can impact one’s professional and social life. Speech therapy services in India are available in very few centers, and people from rural and remote areas face the challenge of getting such services. Hence, there is a need to explore the influence of telerehabilitation for SLPs for providing therapy services over tele mode, focusing on delivering exceptional care for the medically underserved population. Purpose/Aim: To investigate the influence of the tele voice therapy program using smartphones on vocal parameters of individuals with hyper-functional voice disorders. Objectives: 1. To investigate the changes in vocal parameters pre and post teletherapy. 2. To investigate the feasibility and participants’ perception of voice therapy delivered through tele practice. Statistical analysis Descriptive statistics will be used to summarise and describe the collected data. For continuous variables, paired t-test will be used to find the change between the mentioned two points. Wilcoxon signed rank will be used for those not following normal distribution to see the shift between the said two points |