Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524193
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-21
Brief Title:
RCT Face-to-face Group Voice Therapy vs Telepractice Group Voice Therapy for Muscle Tension Dysphonia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparing Face-to-face Group Voice Therapy to Telepractice Group Voice Therapy for Muscle Tension Dysphonia A Non-inferiority Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare face-to-face group voice therapy to telepractice group voice therapy for muscle tension dysphonia MTD The main questions it aims to answer are
The effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design
The effectiveness of telepractice group voice therapy using a randomized controlled trial study design
Participants will receive telepractice group voice therapy or face-to-face group voice therapy Researchers will compare telepractice group voice therapy to face-to-face group voice therapy for patients with MTD to see if it has the same effectiveness
The effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design
The effectiveness of telepractice group voice therapy using a randomized controlled trial study design
Participants will receive telepractice group voice therapy or face-to-face group voice therapy Researchers will compare telepractice group voice therapy to face-to-face group voice therapy for patients with MTD to see if it has the same effectiveness
Detailed Description:
STUDY OBJECTIVES
1 Primary Objectives
1 To evaluate the effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design
2 To evaluate the effectiveness of telepractice group voice therapy using a randomized controlled trial study design
2 Secondary Objectives
1 To compare therapy dropout rate and treatment schedule adherence rate of the two modes of group voice therapy comparing telepractice to face-to-face mode
2 To conduct cost-analysis to compare the health-service cost and patient-related cost of the telepractice and face-to-face group voice therapy
3 To further investigate the role of group climate in contributing to treatment outcome in group voice therapy
BACKGROUND
1 Muscle tension dysphonia
1 Types and prevalence Muscle tension dysphonia MTD is a type of voice disorder that is characterized by excessive paralaryngeal musculature tension during phonation There are two types of MTD primary and secondary Primary MTD is associated with the absence of organic vocal fold pathology whereas secondary MTD is associated with the presence of organic vocal fold pathology
MTD is a prevalent voice disorder which constitutes up to 40 of the total voice disorder caseload In Hong Kong a study by our team also showed that MTD was highly prevalent in every four primary school teachers one would have some degree of MTD
2 Cause risk factors and impact The cause of MTD is multifactorial including incorrect voicing techniques phonotraumatic behaviours such as yelling screaming and prolonged voice use psychological and personality factors compensation of an underlying disease such as organic vocal fold pathology reflux disorder respiratory tract infection Risk factors for MTD include female sex lower education level and people in vocations with high vocal demands
MTD not only disrupts a persons voice quality but also their efficiency to produce voice for communication leading to impaired psychological wellbeing reduced job performance and economic loss due to workplace absenteeism
2 Voice therapy is the treatment for MTD
The current gold standard treatment for primary MTD is behavioural voice therapy delivered by speech-language pathologists For secondary MTD behavioural voice therapy is recommended for those with vocal fold nodules However for other benign vocal fold pathologies such as vocal polyps cysts and granuloma may require phonosurgery as their primary treatment modality
1 Disadvantages of the traditional individual voice therapy Traditionally voice therapy is delivered on a one-to-one basis where speech-language pathologists provide therapy to the patients individually However our team and other researchers reported that individual voice therapy incurs a higher cost increases the waiting time for therapy and has a higher therapy dropout rate In particular poor therapy attendance rate not only jeopardizes clinical outcomes but also wastes healthcare resources
2 Group voice therapy is effective and has many benefits Recent studies including a treatment study by our team showed that voice therapy when delivered in groups are as effective as individual therapy In addition to offsetting the disadvantages of individual therapy our study and other researchers also showed that group voice therapy provided psychosocial support to the group members and facilitated better therapy skills acquisition through group learning Furthermore our team also showed that when a positive group climate is developed it could lead to better treatment outcome and could reduce therapy dropout rate Group climate is the patients perception of therapeutic relationship in the group therapy environment
3 Delivering voice therapy via telepractice
In addition to the individual and group model of service delivery voice therapy has also been extended into telepractice Our team was among the first to introduce and provide preliminary evidence to support the use of telepractice in voice therapy for patients with MTD
1 The reason for telepractice voice therapy Telepractice was initially applied to voice therapy with the aim to reduce service access barriers due to traveling requirements work commitments and access to experienced clinicians and patient mobility However due to the arrival of COVID-19 pandemic social distancing policies and lockdowns have caused an abrupt disruption of all in-person voice therapy programs
This has left thousands of patients worldwide without any treatment and hence has prolonged and aggravated the negative impact on their professional careers and emotional well-being Even for those who can attend in-person voice therapy they are likely to be required to wear masks to mitigate COVID-19 transmission risk It is important to understand that mask wearing can affect a persons voice quality and production As such the treatment effect would unavoidably be impacted
2 The urgent need for evidence to support telepractice voice therapy However after these initial preliminary findings no further research on telepractice voice therapy for MTD was conducted Not until the arrival of COVID-19 pandemic since 2019 researchers and clinicians see the urgency to substantiate the efficacy of telepractice due to its increasing demands and utilization across the globe Nevertheless with the limited studies available researchers were only able to publish recommendation guidelines to guide clinicians in providing voice therapy via telepractice
4 A lack of study on telepractice voice therapy for MTD and on group therapy
Following the preliminary studies on telepractice voice therapy published in 2015 only two additional studies were found in the literature on telepractice voice therapy Although both studies showed that the effectiveness of telepractice voice therapy is comparable to face-to-face therapy they were provided on an individual basis and on different clinical populations One study focused on the elderly population with various types of voice disorders and the other study focused on voice prevention for those who are at risk at developing voice disorder
To date there are no high-quality clinical trials investigating the effectiveness of telepractice voice therapy for patients with MTD especially when delivered in a group model
1 Primary Objectives
1 To evaluate the effectiveness of telepractice voice therapy for MTD using a randomized controlled trial study design
2 To evaluate the effectiveness of telepractice group voice therapy using a randomized controlled trial study design
2 Secondary Objectives
1 To compare therapy dropout rate and treatment schedule adherence rate of the two modes of group voice therapy comparing telepractice to face-to-face mode
2 To conduct cost-analysis to compare the health-service cost and patient-related cost of the telepractice and face-to-face group voice therapy
3 To further investigate the role of group climate in contributing to treatment outcome in group voice therapy
BACKGROUND
1 Muscle tension dysphonia
1 Types and prevalence Muscle tension dysphonia MTD is a type of voice disorder that is characterized by excessive paralaryngeal musculature tension during phonation There are two types of MTD primary and secondary Primary MTD is associated with the absence of organic vocal fold pathology whereas secondary MTD is associated with the presence of organic vocal fold pathology
MTD is a prevalent voice disorder which constitutes up to 40 of the total voice disorder caseload In Hong Kong a study by our team also showed that MTD was highly prevalent in every four primary school teachers one would have some degree of MTD
2 Cause risk factors and impact The cause of MTD is multifactorial including incorrect voicing techniques phonotraumatic behaviours such as yelling screaming and prolonged voice use psychological and personality factors compensation of an underlying disease such as organic vocal fold pathology reflux disorder respiratory tract infection Risk factors for MTD include female sex lower education level and people in vocations with high vocal demands
MTD not only disrupts a persons voice quality but also their efficiency to produce voice for communication leading to impaired psychological wellbeing reduced job performance and economic loss due to workplace absenteeism
2 Voice therapy is the treatment for MTD
The current gold standard treatment for primary MTD is behavioural voice therapy delivered by speech-language pathologists For secondary MTD behavioural voice therapy is recommended for those with vocal fold nodules However for other benign vocal fold pathologies such as vocal polyps cysts and granuloma may require phonosurgery as their primary treatment modality
1 Disadvantages of the traditional individual voice therapy Traditionally voice therapy is delivered on a one-to-one basis where speech-language pathologists provide therapy to the patients individually However our team and other researchers reported that individual voice therapy incurs a higher cost increases the waiting time for therapy and has a higher therapy dropout rate In particular poor therapy attendance rate not only jeopardizes clinical outcomes but also wastes healthcare resources
2 Group voice therapy is effective and has many benefits Recent studies including a treatment study by our team showed that voice therapy when delivered in groups are as effective as individual therapy In addition to offsetting the disadvantages of individual therapy our study and other researchers also showed that group voice therapy provided psychosocial support to the group members and facilitated better therapy skills acquisition through group learning Furthermore our team also showed that when a positive group climate is developed it could lead to better treatment outcome and could reduce therapy dropout rate Group climate is the patients perception of therapeutic relationship in the group therapy environment
3 Delivering voice therapy via telepractice
In addition to the individual and group model of service delivery voice therapy has also been extended into telepractice Our team was among the first to introduce and provide preliminary evidence to support the use of telepractice in voice therapy for patients with MTD
1 The reason for telepractice voice therapy Telepractice was initially applied to voice therapy with the aim to reduce service access barriers due to traveling requirements work commitments and access to experienced clinicians and patient mobility However due to the arrival of COVID-19 pandemic social distancing policies and lockdowns have caused an abrupt disruption of all in-person voice therapy programs
This has left thousands of patients worldwide without any treatment and hence has prolonged and aggravated the negative impact on their professional careers and emotional well-being Even for those who can attend in-person voice therapy they are likely to be required to wear masks to mitigate COVID-19 transmission risk It is important to understand that mask wearing can affect a persons voice quality and production As such the treatment effect would unavoidably be impacted
2 The urgent need for evidence to support telepractice voice therapy However after these initial preliminary findings no further research on telepractice voice therapy for MTD was conducted Not until the arrival of COVID-19 pandemic since 2019 researchers and clinicians see the urgency to substantiate the efficacy of telepractice due to its increasing demands and utilization across the globe Nevertheless with the limited studies available researchers were only able to publish recommendation guidelines to guide clinicians in providing voice therapy via telepractice
4 A lack of study on telepractice voice therapy for MTD and on group therapy
Following the preliminary studies on telepractice voice therapy published in 2015 only two additional studies were found in the literature on telepractice voice therapy Although both studies showed that the effectiveness of telepractice voice therapy is comparable to face-to-face therapy they were provided on an individual basis and on different clinical populations One study focused on the elderly population with various types of voice disorders and the other study focused on voice prevention for those who are at risk at developing voice disorder
To date there are no high-quality clinical trials investigating the effectiveness of telepractice voice therapy for patients with MTD especially when delivered in a group model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None