Determining the effect of play on self-esteem and adaptation of hearing impaired children
Design
Clinical trial with a control group, with parallel groups, a blinded, randomized, on 62 hearing impaired children, block randomization
Settings and conduct
The researcher has visited the educational centers of hearing impaired children in Hamedan city and provides a list of these children, then he contacts the families of the children who are in the study age and invites them. In this study, the children in the control group received routine training and the children in the intervention group will be trained in a group game in 10 sessions under the supervision of the researcher during 2.5 months. Each game session will last about 45 minutes.
The data analyst will be unaware of the allocation of children to the control and intervention group
Participants/Inclusion and exclusion criteria
Inclusion criteria: Desire of children and their parents, Hearing impairment in the range of 35 to 90 decibels
Exclusion criteria: Failure to participate in more than one game session
Intervention groups
During 2.5 months, children in the intervention group, under the supervision of the researcher, will play group games in 10 sessions according to a certain schedule, in order to examine its effect on the children's self-esteem and adaptation. Each game session will last about 45 minutes, and the control group will receive routine care. will receive
Main outcome variables
Coppersmith's self-esteem score ؛ Social adjustment of children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190703044082N7
Registration date:2023-03-21, 1402/01/01
Registration timing:registered_while_recruiting
Last update:2023-03-21, 1402/01/01
Update count:0
Registration date
2023-03-21, 1402/01/01
Registrant information
Name
Fateme Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 4567 8904
Email address
f-mohammadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2023-06-19, 1402/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of play on self-esteem and coping of hearing impaired children
Public title
play on self-esteem and coping of hearing impaired children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction of children and their parents
Children aged 8 to 12 who have hearing impairment
Having no other physical or mental disorders
Children should not be under psychiatric or psychological treatment.
Hearing loss in the frequency range of 35 to 90 (dB)
Exclusion criteria:
Reluctance of parents and children to continue studying
Failure to attend more than one meeting
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation of samples in two intervention and control groups was block random. For random allocation of samples in two control and intervention groups, 6 types of blocks of 4 will be used in the form of block random allocation with replacement method. In this way, the letter A for the intervention group and the letter B for the control group will be considered using a simple random method. We will write the following blocks on the pieces of paper and put them in the envelope and remove them randomly. Then, according to the possible order of sampling, it will start as AABB, BBAA, ABBA, BAAB, ABAB, BABA. Based on the order of the letters of the blocks, children will be assigned to the intervention or control group. Then the next blocks will be selected in the same way.
Blinding (investigator's opinion)
Single blinded
Blinding description
With the coordination of the center manager, the people who are in the test group will visit on even days and the people in the control group will visit on odd days .The statistical analyst also does not know the allocation of people in the intervention and control groups and their names
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Hamadan University of Medical Sciences
Street address
Beginning of Khajeh Rashid Blvd, Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838698
Approval date
2023-03-09, 1401/12/18
Ethics committee reference number
IR.UMSHA.REC.1401.1045
Health conditions studied
1
Description of health condition studied
Hearing loss
ICD-10 code
H90
ICD-10 code description
Conductive and sensorineural hearing loss
Primary outcomes
1
Description
Coppersmith's self-esteem score
Timepoint
The beginning, immediately after the intervention, one month after the intervention
Method of measurement
Coppersmith self-esteem scale
2
Description
Social adjustment of children
Timepoint
The beginning, immediately after the intervention, one month after the intervention
Method of measurement
Sinha and Singh student compatibility questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: During ten 45-minute sessions, the intervention group will receive group games according to the pre-determined schedule under the supervision of the researcher. (including: crafts, bubble making, play dough...)
Category
Treatment - Other
2
Description
Control group: The control group will receive routine care.(including the use of limited play equipment available in the center and without grouping and group play)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nyusha Deaf Center
Full name of responsible person
Nyusha Deaf Center
Street address
Turkman alley, Taleghani street, Hamadan
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh mohammadi
Street address
Khajeh Rashid Blvd, Hamedan University of Medical sciences, Hamadan Town
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khajeh Rashid Blvd, Hamedan University of Medical sciences, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hamedan University of Medical Sciences
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khajeh Rashid Blvd, Hamedan University of Medical sciences, Hamadan Town
City
Hamedan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Fateme Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khajeh Rashid Blvd, Hamedan University of Medical sciences, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6517838698
Phone
+98 81 3334 5634
Email
F-mohammadi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available