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General information
2025-02-19, 1403/12/01
2025-01-20, 1403/11/01
2025-0201-1920 00:00:00
empty
The sampling date was changed
The sampling date was changed
empty
تاریخ نمونه گیری تغییر داده شد
تاریخ نمونه گیری تغییر داده شد
Recruitment centers
#1
Name of recruitment center - English: Kot Abdullah Karun Health Center
Name of recruitment center - Persian: مرکزبهداشتی کوت عبدالله کارون
Full name of responsible person - English: Fatemeh Fakharzadeh
Full name of responsible person - Persian: فاطمه فخارزاده
Street address - English: Ahvaz - Karun (Kot Abdullah) - Ayatollah Behbahani Blvd. - Falke Khazami - next to Sina Hospital
Street address - Persian: اهواز_کارون(کوت عبداله)_بلوار آیت الله بهبهانی_فلکه خزامی_جنب بیمارستان سینا
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3555 6021
Fax:
Email: fakharzadeh.f@ajums.ac.ir
Web page address:
Name of recruitment center - English: Kot Abdullah Karun Health Center
Name of recruitment center - Persian: مرکزبهداشتی کوت عبدالله کارون
Full name of responsible person - English: Fatemeh Fakharzadeh
Full name of responsible person - Persian: فاطمه فخارزاده
Street address - English: Next to Sina Hospital-Ayatollah Behbahani Blvd-Ahvaz - Karun (Kut Abdollah)
Street address - Persian: اهواز_کارون(کوت عبداله)_بلوار آیت الله بهبهانی_جنب بیمارستان سینا
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3555 6021
Fax:
Email: fakharzadeh.f@ajums.ac.ir
Web page address:
Name of recruitment center - English: Kot Abdullah Karun Health Center Name of recruitment center - Persian: مرکزبهداشتی کوت عبدالله کارون Full name of responsible person - English: Fatemeh Fakharzadeh Full name of responsible person - Persian: فاطمه فخارزاده Street address - English: Next to Sina Hospital-Ayatollah Behbahani Blvd-Ahvaz - Karun (Kot AbdullahKut Abdollah) - Ayatollah Behbahani Blvd. - Falke Khazami - next to Sina Hospital Street address - Persian: اهواز_کارون(کوت عبداله)_بلوار آیت الله بهبهانی_فلکه خزامی_جنب بیمارستان سینا City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 61 3555 6021 Fax: Email: fakharzadeh.f@ajums.ac.ir Web page address:
#2
Name of recruitment center - English: Kian Abad Health Center
Name of recruitment center - Persian: مرکز بهداشت کیان آباد
Full name of responsible person - English: Fatemeh Fakharzadeh
Full name of responsible person - Persian: فاطمه فخارزاده
Street address - English: Ahvaz - corner of 14 Kian Abad St
Street address - Persian: اهواز_نبش خیابان 14 کیان آباد
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3338 4844
Fax:
Email: fakharzadeh.f@ajums.ac.ir
Web page address:
Name of recruitment center - English: Kian Abad Health Center
Name of recruitment center - Persian: مرکز بهداشت کیان آباد
Full name of responsible person - English: Fatemeh Fakharzadeh
Full name of responsible person - Persian: فاطمه فخارزاده
Street address - English: corner of 14th Kian Abad St-Ahvaz
Street address - Persian: اهواز_نبش خیابان 14 کیان آباد
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3338 4844
Fax:
Email: fakharzadeh.f@ajums.ac.ir
Web page address:
Name of recruitment center - English: Kian Abad Health Center Name of recruitment center - Persian: مرکز بهداشت کیان آباد Full name of responsible person - English: Fatemeh Fakharzadeh Full name of responsible person - Persian: فاطمه فخارزاده Street address - English: Ahvaz - corner of 1414th Kian Abad St-Ahvaz Street address - Persian: اهواز_نبش خیابان 14 کیان آباد City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 61 3338 4844 Fax: Email: fakharzadeh.f@ajums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mehrnoosh Zakirkish
Full name of responsible person - Persian: دکتر مهرنوش ذاکرکیش
Street address - English: Iran, Ahvaz, Golestan St., Ahvaz Jundishapur University of Medical Sciences, Vice-Chancellor of Research and Technology, Ahvaz Jundishapur University of Medical Sciences and Healthcare Services, ground floor
Street address - Persian: ایران، اهواز، خیابان گلستان، دانشگاه علوم پزشکی اهواز جندی شاپور،معاونت تحقیقات و فناوری دانشگاه علوم پزشكي و خدمات بهداشتي درماني جندي شاپور اهواز ، طبقه همکف.
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61357-15794
Phone: +98 61 3373 8383
Fax:
Email: itc@ajums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mehrnoosh Zakirkish
Full name of responsible person - Persian: دکتر مهرنوش ذاکرکیش
Street address - English: Ground floor,Research and Technology Vice-Chancellor of Ahvaz Jundishapur University of Medical Sciences and Health Services,Ahvaz Jundishapur University of Medical Sciences,Golestan St,Ahvaz,Iran
Street address - Persian: ایران، اهواز، خیابان گلستان، دانشگاه علوم پزشکی اهواز جندی شاپور،معاونت تحقیقات و فناوری دانشگاه علوم پزشكي و خدمات بهداشتي درماني جندي شاپور اهواز ، طبقه همکف.
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61357-15794
Phone: +98 61 3373 8383
Fax:
Email: itc@ajums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Mehrnoosh Zakirkish Full name of responsible person - Persian: دکتر مهرنوش ذاکرکیش Street address - English: Iran, Ahvaz, Golestan St., Ahvaz Jundishapur University of Medical Sciences,Ground floor,Research and Technology Vice-Chancellor of Research and Technology, Ahvaz Jundishapur University of Medical Sciences and Healthcare Services, ground floorHealth Services,Ahvaz Jundishapur University of Medical Sciences,Golestan St,Ahvaz,Iran Street address - Persian: ایران، اهواز، خیابان گلستان، دانشگاه علوم پزشکی اهواز جندی شاپور،معاونت تحقیقات و فناوری دانشگاه علوم پزشكي و خدمات بهداشتي درماني جندي شاپور اهواز ، طبقه همکف. City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 61357-15794 Phone: +98 61 3373 8383 Fax: Email: itc@ajums.ac.ir Web page address:
Protocol summary
Study aim
1_the effect of cognitive behavioral counseling based on mindfulness on anxiety about birth and newborn in nulliparous adolescents
2_the effect of cognitive behavioral counseling based on mindfulness on concerns about weight and body image in nulliparous adolescents
3_the effect of cognitive behavioral counseling based on mindfulness on anxiety about emotions and relationships in nulliparous adolescents
Design
A clinical trial with two intervention and control groups, without blinding, simple randomization, the intervention was conducted during 8 sessions on 66 people in the intervention group.
Settings and conduct
After identifying the pregnant adolescents with primiparous children in Kot Abdullah and Kayan health centers, if they met the criteria for participation in the study, the purpose of the research was explained to them. They were placed in two intervention and control groups. Both groups completed the pre-test and then 8 sessions of cognitive-behavioral counseling based on mindfulness were held for the intervention group during 8 weeks, and after the intervention, both groups completed the post-test.
Participants/Inclusion and exclusion criteria
Married teenagers who are first born and have a high anxiety score based on pregnancy anxiety questionnaire, if they wish, will enter the study after filling out a written consent form. Confirmed physical and mental problems in themselves or their spouse are the exclusion criteria for this study.
Intervention groups
The intervention group receives 8 sessions of 90-minute cognitive-behavioral counseling based on mindfulness, once a week, and finally its effect on concerns during pregnancy is evaluated.
Main outcome variables
Reducing concerns during pregnancy in nulliparous adolescents
General information
Reason for update
The sampling date was changed
Acronym
IRCT registration information
IRCT registration number:IRCT20250106064287N1
Registration date:2025-01-08, 1403/10/19
Registration timing:prospective
Last update:2025-01-11, 1403/10/22
Update count:2
Registration date
2025-01-08, 1403/10/19
Registrant information
Name
Fatemeh Fakharzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5423 3549
Email address
fakharzadeh.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2025-08-22, 1404/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Cognitive-Behavioral Therapy Based on Mindfulness on Concerns of Nulliparous Adolescent Pregnant Women
Public title
Concerns during pregnancy of Nulliparous Adolescent
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
marriage
Adolescent 10 to 19 years old
first pregnancy
Gestational age of 20 weeks and above
Reading and writing literacy
High score based on pregnancy concerns questionnaire
Exclusion criteria:
Existence of severe physical problems
Having a history of mental illness confirmed by a psychiatrist in yourself or your spouse
Participation in other psychological training and counseling programs
Existence of high-risk conditions (diabetes mellitus and high blood pressure, etc.)
Age
From 10 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible people will be selected for the study by available sampling method and then the participants will be divided into intervention and control groups using simple randomization method. The randomization method used in this study is the use of a table of random numbers. The table of random numbers is a collection of numbers that are generated without a specific pattern or order and completely randomly, and turned into a table. At first, the direction of reading numbers from the table was determined. The direction of reading numbers from the table of random numbers in this study. is from the left side, then the even numbers extracted from the table were assigned to the intervention group and the odd numbers extracted from the table were assigned to the control group. Each group consists of 33 participants.In this study, due to the nature of the interventions, it is practically not possible for the participants and the researcher to be blinded due to the knowledge of the participants about being in the intervention group and the training of the content of the sessions by the researcher, but the concealment of the random allocation by a central method and by another person will take place This ensures that there will be no bias in the selection of intervention and control groups and that the effects of the intervention will be evaluated accurately and fairly.
Blinding (according to the researcher)
Not blinded
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
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd., Esfand St., Jundishapur University of Medical Sciences, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2024-12-21, 1403/10/01
Ethics committee reference number
IR.AJUMS.REC.1403.515
Health conditions studied
1
Description of health condition studied
Concerns during pregnancy
ICD-10 code
R45.82
ICD-10 code description
Worries
Primary outcomes
1
Description
Concerns during pregnancy
Timepoint
Before the start of the intervention, immediately after the end of the intervention sessions, 4 weeks after the end of the intervention
Method of measurement
Prenatal Distress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, 8 cognitive-behavioral counseling sessions based on mindfulness will be held during 8 90-minute sessions. In order to evaluate the results of the treatment, relevant questionnaires will be completed by the participants before the intervention, immediately after the intervention, and 4 weeks after the intervention. and will be used for statistical analysis
Category
Treatment - Other
2
Description
Control group: Control group: will receive usual care. In order to evaluate the treatment results, relevant questionnaires will be completed by the participants before the intervention, immediately after the intervention and 4 weeks after the intervention and will be used for statistical analysis
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kot Abdullah Karun Health Center
Full name of responsible person
Fatemeh Fakharzadeh
Street address
Next to Sina Hospital-Ayatollah Behbahani Blvd-Ahvaz - Karun (Kut Abdollah)
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3555 6021
Email
fakharzadeh.f@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Kian Abad Health Center
Full name of responsible person
Fatemeh Fakharzadeh
Street address
corner of 14th Kian Abad St-Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3338 4844
Email
fakharzadeh.f@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoosh Zakirkish
Street address
Ground floor,Research and Technology Vice-Chancellor of Ahvaz Jundishapur University of Medical Sciences and Health Services,Ahvaz Jundishapur University of Medical Sciences,Golestan St,Ahvaz,Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8383
Fax
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon Najafabadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 1373 8071
Email
mitratadayon2000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mitra Tadayon Najafabadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan St
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 1373 8071
Email
mitratadayon2000@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Fakharzadeh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Eastern Jhanbazan Blvd., Alley 21, the second side on the right
City
Jahrom
Province
Fars
Postal code
7417833951
Phone
+98 71 5423 3549
Email
fakharzadeh.f@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data of the study are classified and coded so that the names of the people cannot be identified
When the data will become available and for how long
Access to the study data is possible after the results are published in the journal
To whom data/document is available
All people who want to use the data in this field can access the study data
Under which criteria data/document could be used
Study data can be used for comparison with other results
From where data/document is obtainable
Mrs. Mitra Tedin Najafabadi, a member of the academic faculty of Jundishapur University of Ahvaz
mitratadayon2000@yahoo.com
What processes are involved for a request to access data/document
The request is sent by e-mail to the person in charge of the scientific or general responsibility of the study