The aim of current study is to investigate the effect of voice therapy based on glottal closure improvement in singers with Muscle Tension dysphonia.
Design
This randomised clinical trial has two parallel groups and three phases. A control group that receives manual therapy plus sham therapy and another group in spite of receiving manual therapy receives voice therapy of current study. This study with parallel group design will be enrolled on 20 patient between ُSeptember 2020 and December 2020. In this study outcome assessment and grouping is conducted blinded. Outcome measures are evaluated before, after and two weeks after treatment sessions ended.
Settings and conduct
This randomized clinical trial will be held in Rehabilitation school of Iran university of medical science. We will try to improve glottal closure in singers suffering from MTD. This study is double-blinded and all the subjects, therapists and judges were blind to the grouping design and data.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
at least 4 years of professional singing experience
history of voice disorder during last month
diagnosed with primary muscle tension dysphonia
Exclusion criteria before randomization :
being smokers
hearing impairment
history of allergy, laryngeal blunt trauma, head injury and phonosurgery
Intervention groups
Current study include two groups.
Control group: This group receives laryngeal manual therapy with sham therapy.
Intervention group: This group receives laryngeal manual therapy plus exercises of "voice therapy based on glottal closure improvement".
Main outcome variables
acoustic measures, closure of vocal folds during vibration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151025024686N2
Registration date:2020-10-04, 1399/07/13
Registration timing:prospective
Last update:2020-10-04, 1399/07/13
Update count:0
Registration date
2020-10-04, 1399/07/13
Registrant information
Name
Nassim Ahmadi
Name of organization / entity
Hamedan Univerity of Medical Science, School of Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
nassim.slp@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-05, 1399/07/14
Expected recruitment end date
2021-02-02, 1399/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of voice therapy based on glottal closure improvement in singers with Muscle Tension dysphonia
Public title
glottal closure improvement in Muscle Tension dysphonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
at least 4 years of professional singing experience
history of voice disorder during last month
diagnosed with primary muscle tension dysphonia (MTD)
Exclusion criteria:
history of allergy, laryngeal blunt trauma, head injury and phonosurgery
hearing impairment
being smoker
Age
From 18 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization method with two blocks will be used. Considering sample size of 20 subjects, 10 double blocks will be generated using www.sealedenvelope.com website. Concealing of randomization will be performed using secret codes in a pocket. Subject will receive a pocket when entering the study and based on the code in the pocket will be divided to certain group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Therapists and subjects will be blind to the grouping of subjects. Pocket concealment was used to make participants and therapist blind to the grouping.
Judges will also be blind to the grouping of subjects and also will not be aware of the phases that the voice and video samples belong to (before or after treatment). For this purpose the assessment results including voice and the video samples of participants' performance played for judges without name, study phase and grouping.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethnic committee of Iran University of medical science
Street address
Iran University of Medical Science,Hemmat highway, Tehran, Iran.
City
تهران
Province
Tehran
Postal code
1516846514
Approval date
2019-11-04, 1398/08/13
Ethics committee reference number
IR.IUMS.REC.1398.808
Health conditions studied
1
Description of health condition studied
Dysphonia
ICD-10 code
R49.0
ICD-10 code description
Dysphonia
2
Description of health condition studied
Voice disturbances
ICD-10 code
R49.8
ICD-10 code description
Other and unspecified voice disturbances
Primary outcomes
1
Description
Acoustic measures
Timepoint
Before intervention, after intervention, two weeks after intervention
Method of measurement
Acoustic analysis using Praat software
2
Description
Vocal fold closed quotient
Timepoint
Before intervention, after intervention, two weeks after intervention
Method of measurement
Electroglottography
Secondary outcomes
1
Description
Voice Quality
Timepoint
Before intervention, after intervention, two weeks after intervention
Method of measurement
Auditory-Perceptual Rating Instrument for the Operatic Singing Voice( EAI scale)
2
Description
Singing voice handicap
Timepoint
Before intervention, after intervention, two weeks after intervention
Method of measurement
Persian version of Singing voice handicap index
3
Description
Stroboscopic observational indices
Timepoint
Before intervention, after intervention, two weeks after intervention
Method of measurement
Voice-Vibratory Assessment With Laryngeal Imaging (VALI) Form
Intervention groups
1
Description
Intervention group: This group will receive laryngeal manual therapy performed by Mathieson LMT method. Also exercises of "voice therapy based on glottal closure improvement" is provided to these participants.َ Assessment and treatment is continued for nine weeks and participants will have two 30-minutes sessions each week. Vocal assessments are performed before, after and two weeks after treatment ending. Totally participants will have 3 assessment sessions and 10 treatment sessions.
Category
Rehabilitation
2
Description
Control group: This group will receive laryngeal manual therapy plus sham therapy for ten sessions. Laryngeal manual therapy is performed with Mathieson LMT method. In Sham therapy some information about larynx structure, voicing mechanism and laryngeal pathologies is provided. Assessment and treatment is continued for nine weeks and participants will have two 30-minutes sessions each week. Vocal assessments are performed before, after and two weeks after treatment ending. Totally participants will have 3 assessment sessions and 10 treatment sessions.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Speech therapy clinic
Full name of responsible person
Tahereh Shahrokhi
Street address
School of Rehabilitation, Iran university of Medical Science, Nezam street, Shahnazari street, Madar square, Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
4391 - 15875
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
rehab@iums.ac.ir
Web page address
http://rehab.iums.ac.ir/
2
Recruitment center
Name of recruitment center
Khatam-al- Anbya Hospital
Full name of responsible person
Dr Masoud Kazemi
Street address
Vanak Square, up the Mirdamad Boulevard, Rashid Yasemi St.
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۳۱
Phone
+98 21 8888 4040
Fax
+98 21 8879 0298
Email
hrmc@iums.ac.ir
Web page address
https://www.khatamhospital.org/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Abbas Motavalian
Street address
Fifth floor, central Building, Iran University of Medical Sciences, Shahid Hemmat Highway,