History
# Registration date Revision Id
2 2018-04-28, 1397/02/08 43952
1 2016-09-02, 1395/06/12 23363
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  • Protocol summary

    Objective: This study will be designed to reduce depression and anxiety with comparison of the effectiveness of group cognitive behavioral therapy and group cognitive hypnotism in women with premenstrual syndrome. Materials and Methods: The research will be done semi-experimental method on women and girls who will client to 12 Health center of Rasht city in 2016. Premenstrual syndrome (PMS) is defined as a set of physical and psychological symptoms that occur during the Luteal phase of the menstrual cycle. Among this complaint, depression and anxity are more common and aversive. Available sampling will be used for this purpose and 30 women with premenstrual syndrome will be selected and divided to 3 group into 2 Experimental group and 1 control group randomly. Inclusion criteria will be fertility and premenstrual syndrome and exclusion criteria will be negative test Spiegel. The first experimental group will receive 8-week group cognitive behavioral therapy. Also the second group will receive, hypnosis cognitive therapy and the third group will not receive special treatment. 8 item Premenstrual syndrome inventory and the Beck’s questionnaires depression and anxiety will be used in pre-test and Post- test. Covariance analysis and Tukey will be used to analyze the data.
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    هدف: مطالعه حاضر به منظور مقایسه اثر بخشی درمان گروهی شناختی رفتاری با هیپنوتیزم شناختی گروهی بر کاهش افسردگی و اضطراب زنان مبتلا به سندرم پیش از قاعدگی انجام خواهد شد. مواد و روش ها: پژوهش به شیوه نیمه آزمایشی و در بین زنان و دختران مراجع به پایگاه بهداشتی وابسته به مرکز بهداشت شماره 12 شهر رشت در سال 1395 انجام خواهد گرفت. سندرم پیش از قاعدگی به مجموعه ای از علائم جسمی وروانی اطلاق می گردد که درفازلوتئال سیکل قاعدگی روی میدهد و با شروع قاعدگی یا چند روز اول بهبود می یابد از میان این شکایات افسردگی و اضطراب شایعتر و آزاردهنده تر می باشند. به این منظور، با استفاده از نمونه گیری در دسترس تعداد 30 نفر از زنان با سندرم پیش از قاعدگی انتخاب وبه طور تصادفی بین 3 گروه شامل دو گروه آزمایشی و یک گروه کنترل تقسیم خواهند شد. شرایط ورود به مطالعه شامل سن باروری و وجود سندرم پیش از قاعدگی وشرایط خروج وجود تست اشپیگل منفی می باشد. گروه اول 8 جلسه درمان شناختی رفتاری دریافت خواهند کرد. همچنین گروه دوم درمان شناختی هیپنوتیزم دریافت خواهند نمود و گروه سوم درمانی نخواهند نگرفت. پرسشنامه محقق ساخته جمعیت شناختی 8 سوالی سندرم پیش از قاعدگی و پرسشنامه های افسردگی و اضطراب بک در مراحل پیش آزمون وپس آزمون استفاده خواهد شد، به منظور تحلیل داده ها تحلیل کوواریانس وتوکی استفاده خواهد شد.
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    1-comparison of depression score before and after intervention in cognitive-behavioral group therapy in female students with premenstrual syndrome 2- comparison of depression scores before and after cognitive hypnosis intervention in female students with premenstrual syndrome 3- comparison of depression score in two cognitive-behavioral therapy groups and cognitive hypnosis in female students with premenstrual syndrome
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    1-مقایسه نمره افسردگی قبل و بعد از مداخله گروه درمانی شناختی رفتاری در دانشجویان دختر با نشانگان پیش از قاعدگی 2مقایسه نمره افسردگی قبل و بعد از مداخله هیپنوتیزم شناختی در دانشجویان دختر با نشانگان پیش از قاعدگی 3- مقایسه نمره افسردگی در دو گروه درمانی شناختی رفتاری و هیپنوتیزم شناختی در دانشجویان دختر با نشانگان پیش از قاعدگی
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    community-based and pragmatic control group, with parallel groups, blinded and randomized.
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    دارای گروه کنترل، مبتنی بر جامعه و عمل گرا، با گروه های موازی، یک سویه کور و تصادفی شده
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    The aim of this study was to compare the effects of two methods of cognitive-behavioral group therapy and group cognitive hypnosis on depression in female students in 2018 in Islamic Azad University. The type of research is experimental . The study groups consisted of two experimental groups and one control group, who were not aware of the inclusion of one-way blind in intervention groups and only participated in a study to study the premenstrual syndrome.
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    پژوهش با هدف مقایسه تأثیر دو روش گروه درمانی شناختی - رفتاری و هیپنوتیزم شناختی گروهی بر میزان افسردگی دانشجویان دختر در سال 1397در دانشگاه آزاد اسلامی انجام خواهد شد. نوع پژوهش تجربی خواهد بود. گروه های مورد مطالعه شامل دو گروه آزمایش و یک گروه کنترل هستند که با کور سازی یک سویه از گنجانده شدن در گروه های مداخله اطلاعی نداشته اند.
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    ٍEntering the study include being a student in one of the psychology courses, ages 18 to 50, the absence of mental disorders, including depression and PMS in the family, and the lack of drug use, and the exit criterion is the existence of a negative Spigel test for hypnosis.
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    شرایط ورود دانشجو بودن در یکی از مقاطع رشته روانشناسی، سن 18 تا 50 سال و عدم مصرف دارو و معیار خروج وجود تست اشپیگل منفی برای انجام هیپنوتیزم می باشد
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    The first test group (cognitive-behavioral group therapy) The second test group ( group of cognitive hypnosis treatment) The control group(non intervention)
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    گروه آزمایش اول (درمان گروهی شناختی رفتاری ) گروه آزمایش دوم (درمان گروهی هیپنوتیزم شناختی ) گروه کنترل (بدون مداخله)
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    Comparison of the Effect of Two Psychological Therapies on depression; The Effect of Two Psychological Therapies on depression in Students
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    مقایسه تأثیر دو درمان روانشناختی بر افسردگی؛ بررسی اثربخشی دو درمان روانشناختی بر افسردگی در دانشجویان
  • General information

    PMS
    15
    18
    49
    50
    1
    1
    2016-09-19, 1395/06/29
    2018-05-21, 1397/02/31
    2017-02-18, 1395/11/30
    2018-06-21, 1397/03/31
    cognitive hypnotism for anxiety in women with premenstrual syndrome
    Comparison of group cognitive- behavioral therapy and group cognitive hypnotism on Degree of depression in girl students.
    اثربخشی درمان شناختی رفتاری و هیپنوتیزم شناختی بر سندرم پیش از قاعدگی
    مقایسه گروه درمانی شناختی - رفتاری و هیپنوتیزم شناختی گروهی بر میزان افسردگی دانشجویان دختر
    Comparison of the effectiveness of group cognitive behavioral therapy and group cognitive hypnotism for anxiety in women with premenstrual syndrome
    Comparison of the effect of two methods of group cognitive- behavioral therapy and group cognitive hypnotism on Degree of depression in girl students with premenstrual syndrome.
    مقایسه اثربخشی درمان شناختی رفتاری و هیپنوتیزم شناختی بر اضطراب و افسردگی زنان مبتلا به سندرم پیش از قاعدگی
    مقایسه تأثیر دو روش گروه درمانی شناختی - رفتاری و هیپنوتیزم شناختی گروهی بر میزان افسردگی دانشجویان دختر با نشانگان پیش از قاعدگی
    Being a student in one of the psychology courses
    aged 18 to 50 years
    lack of medication
    دانشجو بودن در یکی از مقاطع رشته روانشناسی
    سن 18 تا 50 سال
    عدم مصرف دارو
    negative spiegel test for hypnosis
    تست اشپیگل منفی برای انجام هیپنوتیزم
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    In this research, simple randomization method will be used. In this way, people in the test and control groups or lottery will be selected and will be replaced by lottery in these groups. Accident Unit: Individual Randomization Tool: Draw a random numbered table Participants will not be aware of the status of the target group until the completion of the study.
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    در این پژوهش از روش تصادفی سازی ساده استفاده خواهد شد. به این ترتیب که افراد در گروه های آزمایش و کنترل یا قرعه کشی انتخاب و با قرعه کشی در این گروه ها جایگزین خواهند شد. واحد تصادف سازی: فردی ابزار تصادفی سازی : قرعه کشی با جدول اعداد تصادفی شرکت کنندگان تا زمان اتمام مطالعه از قرار گرفتن در گروه های مورد نظر اطلاعی نخواهند داشت.
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    Participants will not be aware of the status of the target group until the completion of the study.
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    شرکت کنندگان تا پس از اتمام مطالعه از قرار داشتن در گروه های آزمایشی و کنترل اطلاع نخواهند داشت.
  • Ethics committees

    #1
    IR.IAU.RASHT.REC.1395.7
    IR.GUMS.REC.1396.534
  • Primary outcomes

    #1
    Anxity
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    اضطراب
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    Before and after the intervention
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    قبل و بعد از مداخله
    empty
    Beck Anxity Inventory
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    پرسشنامه اضطراب بک
    empty
  • Recruitment centers

    #1
    Name of recruitment center - English: Holistic Nursing Research Center
    Name of recruitment center - Persian: مرکز تحقیقات پرستاری جامع نگر
    Full name of responsible person - English: Sedigheh Pakseresht
    Full name of responsible person - Persian: صدیقه پاک سرشت
    Street address - English: Rasht, belt martyr Beheshti, Faculty of Nursing and Midwifery
    Street address - Persian: رشت، کمربندی شهید بهشتی، دانشکده پرستاری و مامایی
    City - English: Rasht
    City - Persian: رشت
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Holistic Nursing Research Center
    Name of recruitment center - Persian: مرکز تحقیقات پرستاری جامع نگر
    Full name of responsible person - English: Sedigheh Pakseresht
    Full name of responsible person - Persian: صدیقه پاک سرشت
    Street address - English: Rasht, belt martyr Beheshti, Faculty of Nursing and Midwifery
    Street address - Persian: رشت، کمربندی شهید بهشتی، دانشکده پرستاری و مامایی
    City - English: Rasht
    City - Persian: رشت
    Province: Guilan
    Country: Iran (Islamic Republic of)
    Postal code: 4154974416
    Phone: +98 13 3350 1139
    Fax:
    Email: moghtaderleila@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for research of Gilan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی گیلان
    Full name of responsible person - English: Sedigheh Pakseresht
    Full name of responsible person - Persian: صدیقه پاک سرشت
    Street address - English: Rasht, belt martyr Beheshti, Faculty of Nursing and Midwifery
    Street address - Persian: رشت، کمربندی شهید بهشتی، دانشکده پرستاری و مامایی
    City - English: Rasht
    City - Persian: رشت
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for research of Gilan University of Medical Sciences
    Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی گیلان
    Full name of responsible person - English: Sedigheh Pakseresht
    Full name of responsible person - Persian: صدیقه پاک سرشت
    Street address - English: Rasht, belt martyr Beheshti, Faculty of Nursing and Midwifery
    Street address - Persian: رشت، کمربندی شهید بهشتی، دانشکده پرستاری و مامایی
    City - English: Rasht
    City - Persian: رشت
    Province: Guilan
    Country: Iran (Islamic Republic of)
    Postal code: 4154974416
    Phone: +98 13 3350 1139
    Fax:
    Email: m0ghtaderleila@yahoo.com
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
    Guilan University of Medical Science
    دانشگاه علوم پزشکی گیلان
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Azad University
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی
    Full name of responsible person - English: Leila Moghtader
    Full name of responsible person - Persian: لیلا مقتدر
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasht, pole Taleshan, Azad University
    Street address - Persian: رشت، پل طالشان، دانشگاه آزاد اسلامی
    City - English: Rasht
    City - Persian: رشت
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 13 3350 1139
    Mobile: +98 911 230 3071
    Fax:
    Email: moghtaderleila@yahoo.com moghtader@iaurasht.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Azad University
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی
    Full name of responsible person - English: Leila Moghtader
    Full name of responsible person - Persian: لیلا مقتدر
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasht, pole Taleshan, Azad University
    Street address - Persian: رشت، پل طالشان، دانشگاه آزاد اسلامی
    City - English: Rasht
    City - Persian: رشت
    Province: Guilan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4154974416
    Phone: +98 13 3350 1139
    Mobile: +98 911 230 3071
    Fax:
    Email: moghtaderleila@yahoo.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Azad University
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی
    Full name of responsible person - English: Leila Moghtader
    Full name of responsible person - Persian: لیلا مقتدر
    Position - English: ph.D psychology
    Position - Persian: دکتری روانشناسی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasht, Paul Taleshan, Islamic Azad University
    Street address - Persian: رشت، پل طالشان، دانشگاه آزاد اسلامی
    City - English: Rasht
    City - Persian: رشت
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 13 3350 1139
    Mobile: 00
    Fax:
    Email: moghtaderleila@yahoo.commoghtader@iaurasht.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Azad University
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی
    Full name of responsible person - English: Leila Moghtader
    Full name of responsible person - Persian: لیلا مقتدر
    Position - English: ph.D psychology
    Position - Persian: دکتری روانشناسی
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasht, Paul Taleshan, Islamic Azad University
    Street address - Persian: رشت، پل طالشان، دانشگاه آزاد اسلامی
    City - English: Rasht
    City - Persian: رشت
    Province: Guilan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4154974416
    Phone: +98 13 3350 1139
    Mobile: +98 911 230 3071
    Fax:
    Email: moghtaderleila@yahoo.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Azad University
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی
    Full name of responsible person - English: Leila Moghtader
    Full name of responsible person - Persian: لیلا مقتدر
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasht, Paul Taleshan, Islamic Azad University
    Street address - Persian: رشت . پل طالشان، دانشگاه آزاد اسلامی
    City - English: Rasht
    City - Persian: رشت
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: 00
    Mobile: +98 911 230 3071
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Azad University
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی
    Full name of responsible person - English: Leila Moghtader
    Full name of responsible person - Persian: لیلا مقتدر
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Rasht, Paul Taleshan, Islamic Azad University
    Street address - Persian: رشت . پل طالشان، دانشگاه آزاد اسلامی
    City - English: Rasht
    City - Persian: رشت
    Province: Guilan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4154974416
    Phone: +98 13 3350 1139
    Mobile: +98 911 230 3071
    Fax:
    Email: moghtaderleila@yahoo.com
    Web page address:
  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    Not having enough time
    empty
    نداشتن فرصت کافی

Protocol summary

Study aim
1-comparison of depression score before and after intervention in cognitive-behavioral group therapy in female students with premenstrual syndrome 2- comparison of depression scores before and after cognitive hypnosis intervention in female students with premenstrual syndrome 3- comparison of depression score in two cognitive-behavioral therapy groups and cognitive hypnosis in female students with premenstrual syndrome
Design
community-based and pragmatic control group, with parallel groups, blinded and randomized.
Settings and conduct
The aim of this study was to compare the effects of two methods of cognitive-behavioral group therapy and group cognitive hypnosis on depression in female students in 2018 in Islamic Azad University. The type of research is experimental . The study groups consisted of two experimental groups and one control group, who were not aware of the inclusion of one-way blind in intervention groups and only participated in a study to study the premenstrual syndrome.
Participants/Inclusion and exclusion criteria
ٍEntering the study include being a student in one of the psychology courses, ages 18 to 50, the absence of mental disorders, including depression and PMS in the family, and the lack of drug use, and the exit criterion is the existence of a negative Spigel test for hypnosis.
Intervention groups
The first test group (cognitive-behavioral group therapy) The second test group ( group of cognitive hypnosis treatment) The control group(non intervention)
Main outcome variables
Comparison of the Effect of Two Psychological Therapies on depression; The Effect of Two Psychological Therapies on depression in Students

General information

Reason for update
Acronym
PMS
IRCT registration information
IRCT registration number: IRCT2016090228931N1
Registration date: 2016-09-02, 1395/06/12
Registration timing: prospective

Last update: 2018-04-29, 1397/02/09
Update count: 1
Registration date
2016-09-02, 1395/06/12
Registrant information
Name
Leila Moghtader
Name of organization / entity
Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3350 1139
Email address
moghtaderleila@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Rasht Azad University of Medical Sciences
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of group cognitive- behavioral therapy and group cognitive hypnotism on Degree of depression in girl students with premenstrual syndrome.
Public title
Comparison of group cognitive- behavioral therapy and group cognitive hypnotism on Degree of depression in girl students.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being a student in one of the psychology courses aged 18 to 50 years lack of medication
Exclusion criteria:
negative spiegel test for hypnosis
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, simple randomization method will be used. In this way, people in the test and control groups or lottery will be selected and will be replaced by lottery in these groups. Accident Unit: Individual Randomization Tool: Draw a random numbered table Participants will not be aware of the status of the target group until the completion of the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will not be aware of the status of the target group until the completion of the study.
Placebo
Not used
Assignment
Parallel
Other design features
After sampling, two experimental groups and one control group will be separat by lottery

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Rasht University of Medical Sciences
Street address
Rasht, Pole Taleshan, Azad University
City
Rasht
Province
Guilan
Postal code
4154974416
Approval date
2016-08-10, 1395/05/20
Ethics committee reference number
IR.GUMS.REC.1396.534

Health conditions studied

1

Description of health condition studied
Premenstrual Syndrome
ICD-10 code
F99
ICD-10 code description
Mental disorder, not otherwise specified

Primary outcomes

1

Description
Depression
Timepoint
Before and after the intervention
Method of measurement
Beck Depression Inventory

Secondary outcomes

empty

Intervention groups

1

Description
The first experimental group: eight 2-hour sessions of cognitive behavior therapy
Category
Behavior

2

Description
The first experimental group: eight 2-hour sessions of Cognitive Hypnotherapy
Category
Behavior

3

Description
No action
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Holistic Nursing Research Center
Full name of responsible person
Sedigheh Pakseresht
Street address
Rasht, belt martyr Beheshti, Faculty of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4154974416
Phone
+98 13 3350 1139
Email
moghtaderleila@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Gilan University of Medical Sciences
Full name of responsible person
Sedigheh Pakseresht
Street address
Rasht, belt martyr Beheshti, Faculty of Nursing and Midwifery
City
Rasht
Province
Guilan
Postal code
4154974416
Phone
+98 13 3350 1139
Email
m0ghtaderleila@yahoo.com
Grant name
Guilan University of Medical Science
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Gilan 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
Azad University
Full name of responsible person
Leila Moghtader
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Rasht, pole Taleshan, Azad University
City
Rasht
Province
Guilan
Postal code
4154974416
Phone
+98 13 3350 1139
Fax
Email
moghtaderleila@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Azad University
Full name of responsible person
Leila Moghtader
Position
ph.D psychology
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Rasht, Paul Taleshan, Islamic Azad University
City
Rasht
Province
Guilan
Postal code
4154974416
Phone
+98 13 3350 1139
Fax
Email
moghtaderleila@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Azad University
Full name of responsible person
Leila Moghtader
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Rasht, Paul Taleshan, Islamic Azad University
City
Rasht
Province
Guilan
Postal code
4154974416
Phone
+98 13 3350 1139
Fax
Email
moghtaderleila@yahoo.com
Web page address

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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