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Protocol summary
Randomized clinical trial, with control group, without blinding, with parallel groups, on 60 educable mentally retarded female students
Randomized clinical trial, with control group, without blinding, with parallel groups, on 124educable mentally retarded female students
Randomized clinical trial, with control group, without blinding, with parallel groups, on 60 educable124educable mentally retarded female students
کارآزمایی بالینی تصادفی، با گروه کنترل، بدون کورسازی،با گروه های موازی، بر روی 60 دانش آموز دختر کم توان ذهنی آموزش پذیر
کارآزمایی بالینی تصادفی، با گروه کنترل، بدون کورسازی،با گروه های موازی، بر روی 124دانش آموز دختر کم توان ذهنی آموزش پذیر
کارآزمایی بالینی تصادفی، با گروه کنترل، بدون کورسازی،با گروه های موازی، بر روی 60 دانش124دانش آموز دختر کم توان ذهنی آموزش پذیر
60 educable mentally retarded girls with eligibility criteria are entered into the study after completing the Spence Anxiety Questionnaire by the student and the Ghezel Seflo Aggression Questionnaire by the parent / student guardian. The type of randomization was block randomization with classification on school (schools 1 and 2).These people are divided into two groups of 30 intervention and control using random block size with the size of four blocks. Students are trained in 20 virtual 45-minute yoga sessions. Classes are held 4 times a week for 5 weeks. One month after the end of the sessions, the Spence Anxiety Questionnaire is completed by the student and the Ghezel Seflo Aggression Questionnaire is completed by the student / student's supervisor. The study is not blind.
124 educable mentally retarded girls with eligibility criteria are entered into the study after completing the Spence Anxiety Questionnaire by the student and the Ghezel Seflo Aggression Questionnaire by the parent / student guardian. The type of randomization was block randomization with classification on groups(group1 and 2).These people are divided into two groups of 62intervention and control using random block size with the size of four blocks. Students are trained in 20 virtual 45-minute yoga sessions. Classes are held 4 times a week for 5 weeks. One month after the end of the sessions, the Spence Anxiety Questionnaire is completed by the student and the Ghezel Seflo Aggression Questionnaire is completed by the student / student's supervisor. The study is not blind.
60124 educable mentally retarded girls with eligibility criteria are entered into the study after completing the Spence Anxiety Questionnaire by the student and the Ghezel Seflo Aggression Questionnaire by the parent / student guardian. The type of randomization was block randomization with classification on school (schools 1groups(group1 and 2).These people are divided into two groups of 30 intervention62intervention and control using random block size with the size of four blocks. Students are trained in 20 virtual 45-minute yoga sessions. Classes are held 4 times a week for 5 weeks. One month after the end of the sessions, the Spence Anxiety Questionnaire is completed by the student and the Ghezel Seflo Aggression Questionnaire is completed by the student / student's supervisor. The study is not blind.
60 دختر کم توان ذهنی آموزش پذیر دارای شرایط ورود،پس از تکمیل پرسشنامه های اضطراب اسپنس توسط دانش آموز و پرسشنامه پرخاشگری قزل سفلو توسط والدین/سرپرست دانش آموز وارد مطالعه می شوند.نوع تصادفی سازی از نوع تصادفی سازی بلوکی با طبقه بندی روی مدرسه(مدرسه1و2) بوده است.که این افراد با استفاده از بلوک بندی تصادفی با اندازه ی بلوک های چهارتایی به دو گروه 30نفره ی مداخله و کنترل تقسیم میشوند. دانش اموزان طی 20جلسه ی 45 دقیقه ای مجازی آموزش یوگا ، تحت آموزش قرار می گیرند. کلاس ها به صورت هفته ای 4 جلسه و به مدت 5 هفته برگذار می شود. یک ماه بعد از اتمام جلسات پرسشنامه های اضطراب اسپنس توسط دانش آموز و پرسشنامه پرخاشگری قزل سفلو توسط والدین/سرپرست دانش آموز تکمیل می شود.پژوهش فاقد کورسازی می باشد.
124دختر کم توان ذهنی آموزش پذیر دارای شرایط ورود،پس از تکمیل پرسشنامه های اضطراب اسپنس توسط دانش آموز و پرسشنامه پرخاشگری قزل سفلو توسط والدین/سرپرست دانش آموز وارد مطالعه می شوند.نوع تصادفی سازی از نوع تصادفی سازی بلوکی با طبقه بندی روی گروه ها(گروه1و2) بوده است.که این افراد با استفاده از بلوک بندی تصادفی با اندازه ی بلوک های چهارتایی به دو گروه62نفره ی مداخله و کنترل تقسیم میشوند. دانش اموزان طی 20جلسه ی 45 دقیقه ای مجازی آموزش یوگا ، تحت آموزش قرار می گیرند. کلاس ها به صورت هفته ای 4 جلسه و به مدت 5 هفته برگذار می شود. یک ماه بعد از اتمام جلسات پرسشنامه های اضطراب اسپنس توسط دانش آموز و پرسشنامه پرخاشگری قزل سفلو توسط والدین/سرپرست دانش آموز تکمیل می شود.پژوهش فاقد کورسازی می باشد.
60 دختر124دختر کم توان ذهنی آموزش پذیر دارای شرایط ورود،پس از تکمیل پرسشنامه های اضطراب اسپنس توسط دانش آموز و پرسشنامه پرخاشگری قزل سفلو توسط والدین/سرپرست دانش آموز وارد مطالعه می شوند.نوع تصادفی سازی از نوع تصادفی سازی بلوکی با طبقه بندی روی مدرسه(مدرسه1و2گروه ها(گروه1و2) بوده است.که این افراد با استفاده از بلوک بندی تصادفی با اندازه ی بلوک های چهارتایی به دو گروه 30نفرهگروه62نفره ی مداخله و کنترل تقسیم میشوند. دانش اموزان طی 20جلسه ی 45 دقیقه ای مجازی آموزش یوگا ، تحت آموزش قرار می گیرند. کلاس ها به صورت هفته ای 4 جلسه و به مدت 5 هفته برگذار می شود. یک ماه بعد از اتمام جلسات پرسشنامه های اضطراب اسپنس توسط دانش آموز و پرسشنامه پرخاشگری قزل سفلو توسط والدین/سرپرست دانش آموز تکمیل می شود.پژوهش فاقد کورسازی می باشد.
General information
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Modify the number of samples. correction of the maximum age of the samples
Modify the number of samples. correction of the maximum age of the samples
empty
اصلاح تعداد نمونه ها . اصلاح حداکثر سن نمونه ها.
اصلاح تعداد نمونه ها . اصلاح حداکثر سن نمونه ها.
This study will be performed on 60 educable mentally retarded girls in an intervention group and a control group. Random assignment of these 60 students is done using a random block size of four blocks into a 30-member intervention group (Schools 1 and 2) and a 30-member control group (Schools 1 and 2). The type of randomization was block randomization with classification on school (schools 1 and 2). For random allocation by block method and assigning individuals to 2 intervention groups (T) and control group (c), there are six modes for blocks, Includes: TTCC, TCTC, TCCT, CCTT, CTTC and CTTC. We create random numbers using a computer. For number 1 of combination 1 (CTTC), for number 2 of combination 2 (CCTT), for number 3 of combination 3 (TCCT), for number 4 of combination 4 (TCTC), for number 5 of combination 5 (CTTC) and for Number 6 We use combination 6 (TTCC).
This study will be performed on 124 educable mentally retarded girls in an intervention group and a control group. Random assignment of these 124students is done using a random block size of four blocks into a 62-member intervention group (group1 and 2) and a 62-member control group (group1 and 2). The type of randomization was block randomization with classification on groups (group1 and 2). For random allocation by block method and assigning individuals to 2 intervention groups (T) and control group (c), there are six modes for blocks, Includes: TTCC, TCTC, TCCT, CCTT, CTTC and CTTC. We create random numbers using a computer. For number 1 of combination 1 (CTTC), for number 2 of combination 2 (CCTT), for number 3 of combination 3 (TCCT), for number 4 of combination 4 (TCTC), for number 5 of combination 5 (CTTC) and for Number 6 We use combination 6 (TTCC).
This study will be performed on 60124 educable mentally retarded girls in an intervention group and a control group. Random assignment of these 60 students124students is done using a random block size of four blocks into a 3062-member intervention group (Schools 1group1 and 2) and a 3062-member control group (Schools 1group1 and 2). The type of randomization was block randomization with classification on schoolgroups (schools 1group1 and 2). For random allocation by block method and assigning individuals to 2 intervention groups (T) and control group (c), there are six modes for blocks, Includes: TTCC, TCTC, TCCT, CCTT, CTTC and CTTC. We create random numbers using a computer. For number 1 of combination 1 (CTTC), for number 2 of combination 2 (CCTT), for number 3 of combination 3 (TCCT), for number 4 of combination 4 (TCTC), for number 5 of combination 5 (CTTC) and for Number 6 We use combination 6 (TTCC).
این پژوهش بر روی 60 دختر عقب مانده ذهنی آموزش پذیر در یک گروه مداخله و یک گروه کنترل انجام خواهد شد. تخصیص تصادفی این 60دانش آموز با استفاده از بلوک بندی تصادفی با اندازه ی بلوک های چهارتایی به یک گروه مداخله 30تایی(مدرسه1و2) و یک گروه کنترل 30تایی(مدرسه1و2) صورت می گیرد. نوع تصادفی سازی از نوع تصادفی سازی بلوکی با طبقه بندی روی مدرسه(مدرسه1و2) بوده است.برای تخصیص تصادفی با روش بلوک بندی و تخصیص افراد به 2گروه مداخله(T) و گروه شاهد(c) ، شش حالت برای بلوک ها وجود دارد، شامل : TTCC، TCTC،TCCT ،CCTT،CTTC و CTTC. با استفاده از کامپیوتر اعداد تصادفی ایجاد میکنیم. برای عدد1 از ترکیب 1 (CTTC ) ، برای عدد 2 از ترکیب 2 (CCTT) ، برای عدد 3 از ترکیب 3 (TCCT)، برای عدد 4 از ترکیب 4 (TCTC) ، برای عدد 5 از ترکیب 5(CTTC) و برای عدد 6 از ترکیب 6 ( TTCC) استفاده میکنیم.
این پژوهش بر روی124 دختر عقب مانده ذهنی آموزش پذیر در یک گروه مداخله و یک گروه کنترل انجام خواهد شد. تخصیص تصادفی این 124دانش آموز با استفاده از بلوک بندی تصادفی با اندازه ی بلوک های چهارتایی به یک گروه مداخله 62تایی(گروه1و2) و یک گروه کنترل 62تایی(گروه1و2) صورت می گیرد. نوع تصادفی سازی از نوع تصادفی سازی بلوکی با طبقه بندی روی گروه ها(گروه1و2) بوده است.برای تخصیص تصادفی با روش بلوک بندی و تخصیص افراد به 2گروه مداخله(T) و گروه شاهد(c) ، شش حالت برای بلوک ها وجود دارد، شامل : TTCC، TCTC،TCCT ،CCTT،CTTC و CTTC. با استفاده از کامپیوتر اعداد تصادفی ایجاد میکنیم. برای عدد1 از ترکیب 1 (CTTC ) ، برای عدد 2 از ترکیب 2 (CCTT) ، برای عدد 3 از ترکیب 3 (TCCT)، برای عدد 4 از ترکیب 4 (TCTC) ، برای عدد 5 از ترکیب 5(CTTC) و برای عدد 6 از ترکیب 6 ( TTCC) استفاده میکنیم.
این پژوهش بر روی 60روی124 دختر عقب مانده ذهنی آموزش پذیر در یک گروه مداخله و یک گروه کنترل انجام خواهد شد. تخصیص تصادفی این 60دانش124دانش آموز با استفاده از بلوک بندی تصادفی با اندازه ی بلوک های چهارتایی به یک گروه مداخله 30تایی(مدرسه1و262تایی(گروه1و2) و یک گروه کنترل 30تایی(مدرسه1و262تایی(گروه1و2) صورت می گیرد. نوع تصادفی سازی از نوع تصادفی سازی بلوکی با طبقه بندی روی مدرسه(مدرسه1و2گروه ها(گروه1و2) بوده است.برای تخصیص تصادفی با روش بلوک بندی و تخصیص افراد به 2گروه مداخله(T) و گروه شاهد(c) ، شش حالت برای بلوک ها وجود دارد، شامل : TTCC، TCTC،TCCT ،CCTT،CTTC و CTTC. با استفاده از کامپیوتر اعداد تصادفی ایجاد میکنیم. برای عدد1 از ترکیب 1 (CTTC ) ، برای عدد 2 از ترکیب 2 (CCTT) ، برای عدد 3 از ترکیب 3 (TCCT)، برای عدد 4 از ترکیب 4 (TCTC) ، برای عدد 5 از ترکیب 5(CTTC) و برای عدد 6 از ترکیب 6 ( TTCC) استفاده میکنیم.
Recruitment centers
#1
Name of recruitment center - English: Boostan school
Name of recruitment center - Persian: مدرسه بوستان
Full name of responsible person - English: Nakisa Goodarzi
Full name of responsible person - Persian: نکیسا گودرزی
Street address - English: Shahin Shahr,Shahid Beheshti St., Side 6 West, Bustan School
Street address - Persian: شاهین شهر،خیابان شهید بهشتی، فرعی6غربی، آموزشگاه بوستان
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8314647674
Phone: +98 31 4536 4220
Fax:
Email: azadi3231@gmail.com
Web page address:
Name of recruitment center - English: Boostan school
Name of recruitment center - Persian: مدرسه بوستان
Full name of responsible person - English: Nakisa Goodarzi
Full name of responsible person - Persian: نکیسا گودرزی
Street address - English: Shahin Shahr,Shahid Beheshti St., Side 6 West, Bustan School
Street address - Persian: شاهین شهر،خیابان شهید بهشتی، فرعی6غربی، آموزشگاه بوستان
City - English: Esfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8314647674
Phone: +98 31 4522 7214
Fax:
Email: azadi3231@gmail.com
Web page address:
Name of recruitment center - English: Boostan school Name of recruitment center - Persian: مدرسه بوستان Full name of responsible person - English: Nakisa Goodarzi Full name of responsible person - Persian: نکیسا گودرزی Street address - English: Shahin Shahr,Shahid Beheshti St., Side 6 West, Bustan School Street address - Persian: شاهین شهر،خیابان شهید بهشتی، فرعی6غربی، آموزشگاه بوستان City - English: Esfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8314647674 Phone: +98 31 4536 42204522 7214 Fax: Email: azadi3231@gmail.com Web page address:
Protocol summary
Study aim
Determining the effect of yoga on aggression and anxiety of educable mentally retarded girls
Design
Randomized clinical trial, with control group, without blinding, with parallel groups, on 124educable mentally retarded female students
Settings and conduct
124 educable mentally retarded girls with eligibility criteria are entered into the study after completing the Spence Anxiety Questionnaire by the student and the Ghezel Seflo Aggression Questionnaire by the parent / student guardian. The type of randomization was block randomization with classification on groups(group1 and 2).These people are divided into two groups of 62intervention and control using random block size with the size of four blocks. Students are trained in 20 virtual 45-minute yoga sessions. Classes are held 4 times a week for 5 weeks. One month after the end of the sessions, the Spence Anxiety Questionnaire is completed by the student and the Ghezel Seflo Aggression Questionnaire is completed by the student / student's supervisor. The study is not blind.
Participants/Inclusion and exclusion criteria
be female
Have mental retardation
be educable
No movement restrictions
Got a Score in the questionnaires used
Intervention groups
These people will be trained in 20 sessions of 45 minutes of online yoga training. in each yoga session, exercises (asana) which includes 27 movements, Will be trained. First the special exercises for warming up the body and then the positions of the butterfly, the hello to the sun, and other movements , that will be taught in each session. Breathing exercises (pranayama) will also be performed, which include full inhalation breathing, complete exhalation breathing, and cooling breathing .The control group will not receive any intervention.
Main outcome variables
The main outcome studied in this study is the anxiety and aggression of educable mentally retarded girls
General information
Reason for update
Modify the number of samples. correction of the maximum age of the samples
Acronym
IRCT registration information
IRCT registration number:IRCT20210222050460N1
Registration date:2021-07-31, 1400/05/09
Registration timing:prospective
Last update:2021-08-15, 1400/05/24
Update count:1
Registration date
2021-07-31, 1400/05/09
Registrant information
Name
Pegah Nazarinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4536 4220
Email address
pegah.nazarinezhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of yoga on aggression and anxiety in girls with educable mental retardation
Public title
The effect of yoga on aggression and anxiety in girls with educable mental retardation
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
be FEMALE
Have mental retardation
be educable
No movement restrictions
Got a Score in the questionnaires used
Exclusion criteria:
Reluctance of the participant or his / her supervisor to participate in the study
Failure to attend 2 or more online training sessions
Age
From 6 years old to 20 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
124
More than 1 sample in each individual
Number of samples in each individual:
1
For each mentally retarded person participating in the study, at least one parent or guardian enters the study to complete the questionnaire.
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be performed on 124 educable mentally retarded girls in an intervention group and a control group. Random assignment of these 124students is done using a random block size of four blocks into a 62-member intervention group (group1 and 2) and a 62-member control group (group1 and 2). The type of randomization was block randomization with classification on groups (group1 and 2). For random allocation by block method and assigning individuals to 2 intervention groups (T) and control group (c), there are six modes for blocks, Includes: TTCC, TCTC, TCCT, CCTT, CTTC and CTTC. We create random numbers using a computer. For number 1 of combination 1 (CTTC), for number 2 of combination 2 (CCTT), for number 3 of combination 3 (TCCT), for number 4 of combination 4 (TCTC), for number 5 of combination 5 (CTTC) and for Number 6 We use combination 6 (TTCC).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق در پژوهش دانشکده پرستاری و مامایی دانشگاه علوم پزشکی تهران
Street address
Tohid Square, Dr. Mirkhani St., School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2020-09-19, 1399/06/29
Ethics committee reference number
IR.TUMS.MEDICINE.REC.13991459
Health conditions studied
1
Description of health condition studied
aggression
ICD-10 code
R45.6
ICD-10 code description
Violent behavior
2
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
3
Description of health condition studied
mental retardation
ICD-10 code
F70
ICD-10 code description
Mild intellectual disabilities
Primary outcomes
1
Description
aggression
Timepoint
Before study and 1 month after study
Method of measurement
Ghezel Seflo Aggression Questionnaire
2
Description
anxiety
Timepoint
Before study and 1 month after study
Method of measurement
Spence Anxiety Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: These people will be trained in 20 sessions of 45 minutes of online yoga training (for 5 weeks, 4 sessions per week). in each yoga session, exercises (asana) which includes 27 movements, Will be trained. First the special exercises for warming up the body and then the positions of the butterfly, the wooden horse, the cat pull, the hello to the sun, the angular balance, the boat, the shooter, the bow, the bridge, the camel, the chest pull, the chair, the cobra, the candle, the relaxation. It is a set of stagnation, twisted leaves, cow's head, eagle, fish, lotus, sleeping screw, tree, mountain, stork, swan, triangle, cart that will be taught in each session. Breathing exercises (pranayama) will also be performed, which include full inhalation breathing, complete exhalation breathing, and cooling breathing. At the end of each session, students will participate in a relaxation program that will include relaxation and visualizing an imaginary trip to the beach, sea, forest, and space.
Category
Prevention
2
Description
Control group: Students who do not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Boostan school
Full name of responsible person
Nakisa Goodarzi
Street address
Shahin Shahr,Shahid Beheshti St., Side 6 West, Bustan School
City
Esfahan
Province
Isfehan
Postal code
8314647674
Phone
+98 31 4522 7214
Email
azadi3231@gmail.com
2
Recruitment center
Name of recruitment center
Golestan school
Full name of responsible person
Aghdas Jazayeri
Street address
Gaz Borkhar, Tohid Square, Azadi St., Golestan St., Golestan School
City
Esfahan
Province
Isfehan
Postal code
83441785396
Phone
+98 31 4572 2037
Email
aghdasjazairy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Department of Reproductive Health, Tehran University of Medical Sciences, Nosrat St., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733181
Phone
+98 21 6105 4000
Email
pegah.nazarinezhad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Pegah Nazari NEZHAD
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani St., School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
pegah.nazarinezhad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ziba TaghiZade
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Mirkhani St., School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
taghizad@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Pegah Nazari Nezhad
Position
Master student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani St., School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4217
Email
pegah.nazarinezhad@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
We intend to publish the results and will not distribute the data
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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