Determining the efficiency of puppet show on pragmatic skills of preschool children with hearing loss
Design
22 participants are divided into study or control groups by random numbers table. The study is single-blind. In the study group, children practice pragmatic skills by puppet show. In control group children practice pragmatic skills by usual speach therapy.
Settings and conduct
This study will be done in Soroush care and rehabilitation center in 36 sessions in 3 months. In a paper puppet show, at first, puppets are made according to the story and charming for children then decoration is made with similar equipment. Then children practice language pragmatic skills by performing puppet shows. This study is single-blind and participants don't know about types of practice.
Participants/Inclusion and exclusion criteria
Target population: preschool children with hearing loss of Shiraz care and rehabilitation Soroush
Admission criteria: Age limitation (5-7 years old), Having hearing loss, Having hearing aids or cochlear implantation
Exclusion criteria: Having comorbidity like ADHD, Having mental retardation, Having motor disorders, Child lack of motivation to cooperate in study
Intervention groups
Study group: children practice pragmatic skills by a puppet show. Control group: children practice pragmatic skills by usual speech therapy.
Main outcome variables
Total score of McGuinness Questionnaire of pragmatic skill's assessment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210604051489N1
Registration date:2021-08-28, 1400/06/06
Registration timing:prospective
Last update:2021-08-28, 1400/06/06
Update count:0
Registration date
2021-08-28, 1400/06/06
Registrant information
Name
Seyed Shahin Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3370 7097
Email address
shahinhosseini7755@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficiency of puppet show on pragmatic skills of preschool children with hearing loss: A randomized clinical trials
Public title
Efficiency of puppet show on pragmatic skills of preschool children with hearing loss
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 5-7 years old
Having hearing loss
Having hearing aids or cochlear implantation
Exclusion criteria:
Having comorbidity like ADHD
Having mental retardation
Having motor disorders
No child motivation to cooperate to study
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomizing, single, with the table of random numbers:
First, we assign a number from zero to 22 to each sample, then we start from a random number in the table of random numbers then move and check the numbers on the left and choose the ones which are equal and less than 22. the first 11 numbers would be in the intervention group and the second 11 numbers would be in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the samples are preschool children, none of them have any knowledge of the type of education they receive. So there is no need for blindness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Speech and language development delay due to hearing loss
Primary outcomes
1
Description
Total score of McGuinness Questionnaire of pragmatic skill's assessment
Timepoint
At the beginning of the study and three months after the end of the study
Method of measurement
Filling in the questionnaire under the supervision of a clinical researcher
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Teaching language pragmatic skills by puppet show. This study will be done in Soroush care and rehabilitation center in 36 sessions in 3 months. In a paper puppet show, first, puppets are made according to the story and charming for children then decoration is made with similar equipment. Then children practice language pragmatic skills by performing puppet shows.
Category
Rehabilitation
2
Description
Control group: Teaching language pragmatic skills by normal speech therapy. This group undergoes the usual method of speech therapy in 36 sessions for 3 months.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Soroush care and rehabilitation center
Full name of responsible person
Zahra Zandi
Street address
9/6 Alley, 9 Ave, West Golchin Ave, South motahari Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7151895471
Phone
+98 71 3842 4067
Fax
+98 71 3842 4123
Email
VahabM@Sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Abbas Rezaianzade
Street address
7th floor, Central building of Shiraz medical university, Zand Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Shahin Hosseini
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 14, Block B7, Farhangian apartment, Fazilat Blvd
City
Shiraz
Province
Fars
Postal code
7154884049
Phone
+98 71 3370 7097
Fax
Email
shahinhosseini7755@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Shahin Hosseini
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 14, Block B7, Farhangian apartment, Fazilat Blvd
City
Shiraz
Province
Fars
Postal code
7154884049
Phone
+98 71 3370 7097
Fax
Email
shahinhosseini7755@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Shahin Hosseini
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Unit 14, Block B7, Farhangian apartment, Fazilat Blvd
City
Shiraz
Province
Fars
Postal code
7154884049
Phone
+98 71 3370 7097
Fax
Email
shahinhosseini7755@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD