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The effect of applying virtual yoga technique on depression amongst female adolescents with type 1 diabetes

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History
# Registration date Revision Id
2 2020-08-09, 1399/05/19 146845
1 2019-12-26, 1398/10/05 115511
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  • Protocol summary

    1-Determination and comparison of demographic characteristics of adolescent girls with type 1 diabetes in control groupTest 2-Determination and comparison of mean depression score of adolescent girls with type 1 diabetes before and after exercise With instructor and after individual exercises at home in control group 3-Determination and comparison of mean depression score of adolescent girls with type1 diabetes before and after exercise With instructor and after individual exercises at home in the experimental group 4-Comparison of the mean depression score of adolescent girls with type1 diabetes between control group and pretest From practicing with a coach
    Determining the effect of using virtual yoga technique on depression in female adolescents with type 1 diabetes referred to Imam Reza (AS) clinic in Shiraz in 1398
    1-تعيين و مقایسه مشخصات جمعيت شناختي نوجوانان دختر مبتلا به دیابت نوع 1 در گروه کنترل وآزمون2- تعيين و مقایسه ميانگين نمره افسردگي نوجوانان دختر مبتلا به دیابت نوع1 قبل و پس از تمرین با مربي و بعد از انجام تمرینات فردي در منزل در گروه کنترل3-تعيين و مقایسه ميانگين نمره افسردگي نوجوانان دختر مبتلا به دیابت نوع 1 قبل و پس از تمرین با مربي و بعد از انجام تمرینات فردي در منزل در گروه آزمون 4-مقایسه ميانگين نمره افسردگي نوجوانان دختر مبتلا به دیابت نوع 1بين گروه کنترل و آزمون قبل از تمرین با مربي
    تعیین تأثیر بکارگیری تکنیک یوگا به طور مجازی بر افسردگی نوجوانان دختر مبتلا به دیابت نوع1 مراجعه‌کننده به درمانگاه امام رضا (ع) شیراز سال 1398
    Intervention group: 8 one and a half hour sessions of yoga classes for 8 weeks under the supervision of the test group. Then do yoga exercises at home for 45 minutes twice a week for six weeks.
    8 sessions of yoga classes for 8 weeks are held virtually for the experimental group under the supervision of an instructor and researcher. The first session of the yoga class is held online using the adobe connect application. The rest of the sessions are in the form of sending short videos virtually. Yoga training CDs and report forms will be provided to the test group. In the control group, routine clinic care is performed.
    گروه مداخله: 8 جلسه ي یك و نيم ساعته کلاسهاي یوگا به مدت 8 هفته زیر نظرمربي براي گروه آزمون برگزار مي شود. سپس به مدت شش هفته دوبار در هفته به مدت 45 دقيقه در خانه تمرینات یوگا را انجام دهند گروه کنترل:در حالی که گروه کنترل آموزش معمول (آموزش توسط پرسنل کلینیک) دریافت کرده است.
    8 جلسه‌ کلاسهای یوگا به مدت 8 هفته زیر نظر مربی و پژوهشگر به صورت مجازی برای گروه آزمون برگزار می‌شود. اولین جلسه کلاس یوگا به صورت آنلاین برگزار می‌شود که با استفاده از اپلیکیشنadobe connect می‌باشد. مابقی جلسات در قالب ارسال فیلم کوتاه به صورت مجازی می‌باشد. سی‌دی آموزش یوگا و فرم‌های گزارش در اختیار گروه آزمون قرار می‌گیرد. در گروه کنترل مراقبت معمول درمانگاه انجام می‌گردد.

  • General information

    2020-01-11, 1398/10/21
    2020-09-11, 1399/06/21
    2021-02-09, 1399/11/21
    2020-11-11, 1399/08/21
    empty
    Due to the prevalence of Covid-19 disease and the lack of referral of adolescents with diabetes to Imam Reza (AS) clinic, yoga technique sessions are held virtually. For this purpose, adolescents with type 1 diabetes are randomly divided into control and intervention groups and are asked to complete a depression questionnaire before and 2 months after the start of the study. In the control group, routine clinic care is provided, and in the intervention group, 8 sessions of yoga classes are held virtually for 8 weeks (one session per week) under the supervision of an instructor and a researcher. The first session of the yoga class is held online. The rest of the sessions are in the form of short videos.The duration of these videos is 15 to 20 minutes for each session, and a 30-minute video that includes repetitive movements and each session must be done is sent to the teens in the first session. At the end of the control group, a yoga training session will be sent virtually in the form of a short video.
    empty
    با توجه به شیوع بیماری کووید-19 و عدم مراجعه نوجوانان مبتلا به دیابت به درمانگاه امام رضا(ع) جلسات تکنیک یوگا به طور مجازی برگزار می‌شود. بدین منظور نوجوانان مبتلا به دیابت نوع 1 به طور تصادفی در دو گروه کنترل و مداخله قرار می‌گیرند و از آنها درخواست می‌گردد که پرسشنامه افسردگی را قبل و 2 ماه بعد از شروع مطالعه تکمیل نمایند.در گروه کنترل مراقبت معمول درمانگاه انجام می‌گردد و در گروه مداخله 8 جلسه‌ کلاسهای یوگا به مدت 8 هفته (هفته‌ای یک جلسه) زیر نظر مربی و پژوهشگر به صورت مجازی برگزار می‌شود. اولین جلسه کلاس یوگا به صورت آنلاین برگزار می‌شود. مابقی جلسات در قالب ارسال فیلم کوتاه می‌باشد. مدت زمان این فیلم‌ها برای هر جلسه 15 الی 20 دقیقه می‌باشد و یک فیلم 30 دقیقه‌ای که شامل حرکات تکراری می‌باشد و هر جلسه باید انجام شود در اولین جلسه برای نوجوانان ارسال می‌شود. در پایان جهت گروه کنترل نیز یک جلسه آموزش یوگا به طور مجازی در قالب فیلم کوتاه ارسال خواهد شد.
    The effect of applying yoga technique on depression amongst female adolescents with type 1 diabetes
    The effect of applying virtual yoga technique on depression amongst female adolescents with type 1 diabetes
    بررسي تأثیر بكارگیری تكنیک یوگا بر افسردگي نوجوانان دختر مبتلا به دیابت نوع 1
    بررسي تأثیر بكارگیری تكنیک یوگابه طور مجازی بر افسردگي نوجوانان دختر مبتلا به دیابت نوع 1
    The effect of applying yoga technique on depression amongst female adolescents with type 1 diabetes
    The effect of applying virtual yoga technique on depression amongst female adolescents with type 1 diabetes
    بررسي تأثیر بكارگیری تكنیک یوگا بر افسردگي نوجوانان دختر مبتلا به دیابت نوع 1 مراجعه کننده به درمانگاه امام رضا (ع) شیراز سال 1398
    بررسي تأثیر بكارگیری تكنیک یوگا به طور مجازی بر افسردگي نوجوانان دختر مبتلا به دیابت نوع 1 مراجعه کننده به درمانگاه امام رضا (ع) شیراز سال 1398
    نمونه ها با روش نمونه گيري تصادفي ساده به دو گروه آزمون و کنترل تقسيم خواهند شد. ابتدا به تمام افراد واجد شرایط یك شماره داده مي شود. سپس شماره ها روي کارتي ثبت ميشوند.کليه شماره ها دریك جعبه گذاشته شده و به صورت قرعه کشي نصف افراد انتخاب مي شوند. افراد انتخاب شده وارد گروه A مي گردند و بقيه افراد در گروه B قرار مي گيرند.از دو گروه A و B یكي به تصادف گروه آزمون و یكي گروه کنترل مي باشد
    نمونه ها با روش نمونه گيري تصادفي ساده به دو گروه آزمون و کنترل تقسيم خواهند شد. ابتدا به تمام افراد واجد شرایط یك شماره داده مي شود. سپس شماره ها روي کارتي ثبت ميشوند.کليه شماره ها دریك جعبه گذاشته شده و به صورت قرعه کشي نصف افراد انتخاب مي شوند. افراد انتخاب شده وارد گروه A مي گردند و بقيه افراد در گروه B قرار مي گيرند.از دو گروه A و B یكی به تصادف گروه آزمون و یكي گروه کنترل مي باشد

  • Primary outcomes

    #1
    Before intervention, 8 weeks after intervention and 14 weeks after intervention
    Before intervention, 8 weeks after intervention
    قبل از انجام مداخله، 8هفته بعد از مداخله و 14 هفته بعد از مداخله
    قبل از انجام مداخله، 8هفته بعد از مداخله

  • Intervention groups

    #1
    Intervention group:Before the intervention, depression questionnaire will be completed by adolescents in control and test groups. Intervention is that 8 one and a half hour sessions of yoga classes are held for 8 weeks under the supervision of the test group. These sessions include teaching the basics of yoga and performing postural, breathing, relaxation and meditation exercises. After these 8 sessions of yoga, the Depression Questionnaire will be completed by adolescents in the control and test groups. The Yoga Training CD and Report Forms (Self-Report Checklist: To Control and Track Diabetic Adolescents' Exercises) are provided to the experimental group and are asked to practice at home twice a week for 45 minutes for 45 minutes. Do yoga and then fill in the daily report form The phone call will be conducted weekly by the researcher to follow up on individual exercises at home. At the end of these 6 weeks, the depression questionnaire will be completed by adolescents in the control and test groups.
    Intervention group: Before the intervention, the Depression Questionnaire is completed by the adolescents in the test groups. 8 sessions of yoga classes for 8 weeks (one session per week) are held virtually for the test group under the supervision of an instructor and researcher. The first session of the yoga class is held online using the adobe connect application. The rest of the sessions are in the form of sending short videos virtually. The duration of these videos is 15 to 20 minutes for each session, and a 30-minute video that includes repetitive movements and each session must be done is sent to the teens in the first session. Yoga training CDs and reporting forms (self-report checklist: to control and track diabetic adolescents from exercise) are provided to the test group and they are asked to complete a daily report form. These sessions will include teaching the principles and goals of yoga and performing posture, breathing, relaxation and meditation exercises (meditation from the third session) under the supervision of a yoga instructor. The researcher makes the necessary follow-ups regarding the performance of exercises by adolescents by telephone. Teenagers also make videos of their practice, and the instructor provides observation and feedback. After the intervention, the depression questionnaire is completed again by the adolescents in the test groups.
    گروه مداخله: قبل از مداخله پرسشنامه افسردگی توسط نوجوانان گروه کنترل و آزمون تکمیل می شود. مداخله به این صورت مي باشد که 8 جلسه ي یك و نيم ساعته کلاسهاي یوگا به مدت 8 هفته زیر نظرمربي براي گروه آزمون برگزار مي شود. این جلسات شامل آموزش اصول و اهداف یوگا و انجام تمرینات وضعيتي، تنفسي و آرامسازي و مراقبه می باشد. پس از پایان این 8 جلسه یوگا پرسشنامه افسردگي توسط نوجوانان گروه کنترل و آزمون تكميل خواهد شد. سي دي آموزش یوگا و فرمهاي گزارش (چك ليست خودگزارش دهي: به منظور کنترل و پيگيري نوجوانان دیابتي از انجام تمرینات) در اختيار گروه آزمون قرار مي گيرد و خواسته مي شود که به مدت شش هفته دوبار در هفته به مدت 45 دقيقه در خانه تمرینات یوگا را انجام دهند سپس فرم گزارش روزانه را پرکنند تماس تلفني جهت پيگيري انجام تمرینات فردي در منزل توسط پژوهشگر هر هفته انجام خواهد شد. در پایان این 6هفته نيز پرسشنامه افسردگي توسط نوجوانان گروه کنترل و آزمون تكميل خواهد شد.
    گروه مداخله: قبل از مداخله پرسشنامه افسردگی توسط نوجوانان گروه آزمون تکمیل می شود. 8 جلسه‌ کلاسهای یوگا به مدت 8 هفته (هفته‌ای یک جلسه) زیر نظر مربی و پژوهشگر به صورت مجازی برای گروه آزمون برگزار می‌شود. اولین جلسه کلاس یوگا به صورت آنلاین برگزار می‌شود که با استفاده از اپلیکیشنadobe connect می‌باشد. مابقی جلسات در قالب ارسال فیلم کوتاه به صورت مجازی می‌باشد. مدت زمان این فیلم‌ها برای هر جلسه 15 الی 20 دقیقه می‌باشد و یک فیلم 30 دقیقه‌ای که شامل حرکات تکراری می‌باشد و هر جلسه باید انجام شود در اولین جلسه برای نوجوانان ارسال می‌شود. سی‌دی آموزش یوگا و فرم‌های گزارش(چک لیست خودگزارش‌دهی: به منظور کنترل و پیگیری نوجوانان دیابتی از انجام تمرینات) در اختیار گروه آزمون قرار می‌گیرد و خواسته می‌شود فرم گزارش روزانه را پر کنند. این جلسات شامل آموزش اصول و اهداف یوگا و انجام تمرینات وضعیتی، تنفسی و آرام‌سازی و مراقبه ( مراقبه از جلسه سوم) زیر نظر مربی یوگا خواهد بود. پژوهشگر از طریق تماس تلفنی پیگیریهای لازم در خصوص اجرای تمرینات توسط نوجوانان را انجام می‌دهد. همچنین نوجوانان از تمرین خود فیلم تهیه می‌کنند و مربی مشاهده و بازخورد می‌دهد. پس از انجام مداخله مجددا پرسشنامه افسردگی توسط نوجوانان گروه آزمون تکمیل می‌شود.
    #2
    Control group: Depression questionnaire will be completed by adolescents in the control group before starting the study. Adolescents in this group will receive their routine treatment without any intervention. At the end of the 8th and 14th weeks, they will complete the depression questionnaire. Interventions are compared.
    Control group: Before starting the study, the depression questionnaire is completed by the adolescents in the control group and the adolescents in this group receive their routine treatments without any intervention. In order to observe the ethical principles, after the study, a yoga training session in the form of a short video will be sent to the control group. An educational CD will also be reproduced and made available to them. The depression questionnaire is completed again by the adolescents in the control group.
    گروه کنترل: قبل از شروع مطالعه پرسشنامه افسردگی توسط نوجوانان گروه کنترل تکمیل می شود و نوجوانان این گروه بدون انجام هیچ مداخله ای درمانهای روتین خود را دریافت می کنند و در پایان هفته هشتم و هفته چهاردهم مجدد پرسشنامه افسردگی را تکمیل می کنند و با گروه مداخله مقایسه می شوند.
    گروه کنترل: قبل از شروع مطالعه پرسشنامه افسردگی توسط نوجوانان گروه کنترل تکمیل می شود و نوجوانان این گروه بدون انجام هیچ مداخله ای درمانهای روتین خود را دریافت می کنند. جهت رعایت اصول اخلاقی، بعد از اتمام مطالعه، برای گروه کنترل نیز یک جلسه آموزش یوگا در قالب فیلم کوتاه ارسال خواهد گردید. همچنین سی‌دی آموزشی تکثیر و در اختیار آنان قرار داده خواهد‌شد. مجددا پرسشنامه افسردگی توسط نوجوانان گروه کنترل تکمیل می‌شود.

Protocol summary

Study aim
Determining the effect of using virtual yoga technique on depression in female adolescents with type 1 diabetes referred to Imam Reza (AS) clinic in Shiraz in 1398
Design
A clinical trial with a control group, community-based and pragmatic, with parallel, randomized, random allocation of study samples in the intervention and control groups using simple random sampling
Settings and conduct
Refer to Diabetes Clinic of Imam Reza Clinic of Shiraz, Easy-Targeted Sampling from Adolescents with Type 1 Diabetes Eligible
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-Girl gender2-The age range of adolescents is between 12 and17 years3-No other chronic illness4-Adolescent able to perform yoga exercises as per physician's diagnosis. Exclusion criteria:1-Adolescents and parents unwilling to pursue research cooperation. 2-Unable to continue the exercise on the basis of patient's consent and physician's approval. 3-Missing 2 training sessions4-Incidence of illness and accidents.
Intervention groups
8 sessions of yoga classes for 8 weeks are held virtually for the experimental group under the supervision of an instructor and researcher. The first session of the yoga class is held online using the adobe connect application. The rest of the sessions are in the form of sending short videos virtually. Yoga training CDs and report forms will be provided to the test group. In the control group, routine clinic care is performed.
Main outcome variables
Average Depression

General information

Reason for update
Due to the prevalence of Covid-19 disease and the lack of referral of adolescents with diabetes to Imam Reza (AS) clinic, yoga technique sessions are held virtually. For this purpose, adolescents with type 1 diabetes are randomly divided into control and intervention groups and are asked to complete a depression questionnaire before and 2 months after the start of the study. In the control group, routine clinic care is provided, and in the intervention group, 8 sessions of yoga classes are held virtually for 8 weeks (one session per week) under the supervision of an instructor and a researcher. The first session of the yoga class is held online. The rest of the sessions are in the form of short videos.The duration of these videos is 15 to 20 minutes for each session, and a 30-minute video that includes repetitive movements and each session must be done is sent to the teens in the first session. At the end of the control group, a yoga training session will be sent virtually in the form of a short video.
Acronym
IRCT registration information
IRCT registration number: IRCT20191203045590N1
Registration date: 2019-12-26, 1398/10/05
Registration timing: prospective

Last update: 2020-08-12, 1399/05/22
Update count: 1
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Sedighe Sedigh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 3363 6307
Email address
sedigh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-11, 1399/06/21
Expected recruitment end date
2020-11-11, 1399/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of applying virtual yoga technique on depression amongst female adolescents with type 1 diabetes
Public title
The effect of applying virtual yoga technique on depression amongst female adolescents with type 1 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Girl gender. The age range of adolescents is between 12 and 17 years. No other chronic illness. Adolescent able to perform yoga exercises as per physician's diagnosis.
Exclusion criteria:
Any changes in body posture during exercise Unwillingness to perform regular exercises throughout the study Unwilling to continue to participate in research Severe decrease in blood sugar and death of the patient
Age
From 12 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Examples are simple random sampling with two testing and control groups . they will be divided . First , all qualified people are given a number . then The numbers are registered on a card . all the numbers in the box were arranged in a ballot box People are selected . The selected people will enter the group A and the rest are in Group B .The two groups A and B are one by the accident group and one control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study participants were divided into two experimental and control groups. The participants in the study group received one type of intervention and at the end of the study they were compared with the control group who did not receive any intervention.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical al Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.SUMS.REC.1398.839

Health conditions studied

1

Description of health condition studied
Diabet
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus

Primary outcomes

1

Description
Depression
Timepoint
Before intervention, 8 weeks after intervention
Method of measurement
Childrens Depression Inventory (CDI)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Before the intervention, the Depression Questionnaire is completed by the adolescents in the test groups. 8 sessions of yoga classes for 8 weeks (one session per week) are held virtually for the test group under the supervision of an instructor and researcher. The first session of the yoga class is held online using the adobe connect application. The rest of the sessions are in the form of sending short videos virtually. The duration of these videos is 15 to 20 minutes for each session, and a 30-minute video that includes repetitive movements and each session must be done is sent to the teens in the first session. Yoga training CDs and reporting forms (self-report checklist: to control and track diabetic adolescents from exercise) are provided to the test group and they are asked to complete a daily report form. These sessions will include teaching the principles and goals of yoga and performing posture, breathing, relaxation and meditation exercises (meditation from the third session) under the supervision of a yoga instructor. The researcher makes the necessary follow-ups regarding the performance of exercises by adolescents by telephone. Teenagers also make videos of their practice, and the instructor provides observation and feedback. After the intervention, the depression questionnaire is completed again by the adolescents in the test groups.
Category
Treatment - Other

2

Description
Control group: Before starting the study, the depression questionnaire is completed by the adolescents in the control group and the adolescents in this group receive their routine treatments without any intervention. In order to observe the ethical principles, after the study, a yoga training session in the form of a short video will be sent to the control group. An educational CD will also be reproduced and made available to them. The depression questionnaire is completed again by the adolescents in the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinic of Imam Reza Clinic
Full name of responsible person
Razie Attar
Street address
Imam Reza Clinic Next to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
714737-71348
Phone
+98 71 3212 7605
Fax
+98 71 3647 4673
Email
bonyaddiabet.az13@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Qasemi
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Fax
+98 71 3230 7594
Email
vcrdep@sums.ac.ir
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
Zahra Hadian Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
zhadian@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Hadian Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
zhadian@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sedighe Sedigh
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shiraz University of Medical Sciences, Namazi Square, Zand Street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Fax
Email
sedigh@sums.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
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