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Recruitment centers
#1
Name of recruitment center - English: Shahid Shafiee and Sadoughi Health Centers
Name of recruitment center - Persian: مراکز بهداشتی درمانی شهید شفیعی و صدوقی
Full name of responsible person - English: Khadijeh Hekmat
Full name of responsible person - Persian: خدیجه حکمت
Street address - English: Dolatabad, in front of Shahid Paydar Hall
Street address - Persian: دولت اباد،مقابل سالن شهید پایدار
City - English: Yasuj
City - Persian: یاسوج
Province: Kohgilouyeh-va-Boyrahmad
Country: Iran (Islamic Republic of)
Postal code: 7591615786
Phone: +98 74 3222 2054
Fax:
Email: Hekmat1346@gmail.com
Web page address:
Name of recruitment center - English: Health centers 2 and 3 west of Ahvaz
Name of recruitment center - Persian: مراکز بهداشتی درمانی 2 و 3 غرب اهواز
Full name of responsible person - English: Khadijeh Hekmat
Full name of responsible person - Persian: خدیجه حکمت
Street address - English: The end of Bani Hashem street, South Soroush street - the end of Kian, the first of Alavi alley, corner of Farahani
Street address - Persian: انتهای خیابان بنی هاشم،خیابان سروش جنوبی-انتهای کیان،اول کوی علوی،نبش فراهانی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 7591615786
Phone: +98 61 3379 6534
Fax:
Email: Hekmat1346@gmail.com
Web page address:
Name of recruitment center - English: Shahid ShafieeHealth centers 2 and Sadoughi Health Centers3 west of Ahvaz Name of recruitment center - Persian: مراکز بهداشتی درمانی شهید شفیعی2 و صدوقی3 غرب اهواز Full name of responsible person - English: Khadijeh Hekmat Full name of responsible person - Persian: خدیجه حکمت Street address - English: Dolatabad, in frontThe end of Shahid Paydar HallBani Hashem street, South Soroush street - the end of Kian, the first of Alavi alley, corner of Farahani Street address - Persian: دولت ابادانتهای خیابان بنی هاشم،مقابل سالن شهید پایدارخیابان سروش جنوبی-انتهای کیان،اول کوی علوی،نبش فراهانی City - English: YasujAhvaz City - Persian: یاسوجاهواز Province: Kohgilouyeh-va-BoyrahmadKhouzestan Country: Iran (Islamic Republic of) Postal code: 7591615786 Phone: +98 74 3222 205461 3379 6534 Fax: Email: Hekmat1346@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Khadijeh Hekmat
Full name of responsible person - Persian: خدیجه حکمت
Street address - English: Golestan St., Razi School of Nursing and Midwifery
Street address - Persian: خیابان گلستان،دانشکده پرستاری مامایی رازی
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61357-15794
Phone: +98 61 3311 3537
Fax:
Email: info@ajums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Kourosh Zarea
Full name of responsible person - Persian: کوروش زارع
Street address - English: Golestan Road, Shahr-e-Daneshgahi, Ahvaz School of Nursing and Midwifery, Vice Chancellor for Research, Second Floor
Street address - Persian: جاده گلستان،شهردانشگاهی، دانشکده پرستاری و مامایی اهواز،معاونت پژوهشی،طبقه دوم
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 61357-15794
Phone: +98 61 3373 8395
Fax:
Email: zarea_k@ajums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Khadijeh HekmatKourosh Zarea Full name of responsible person - Persian: خدیجه حکمتکوروش زارع Street address - English: Golestan St.Road, RaziShahr-e-Daneshgahi, Ahvaz School of Nursing and Midwifery, Vice Chancellor for Research, Second Floor Street address - Persian: خیابانجاده گلستان،شهردانشگاهی، دانشکده پرستاری و مامایی رازیاهواز،معاونت پژوهشی،طبقه دوم City - English: Ahvaz City - Persian: اهواز Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 61357-15794 Phone: +98 61 3311 35373373 8395 Fax: Email: infozarea_k@ajums.ac.ir Web page address:
Protocol summary
Study aim
Determining the effectiveness of Emotional Freedom Technique on fear of childbirth in nulliparous women
Design
Clinical trial with control and intervention group, one-way blind, randomized, on 116 nulliparous women, permutation blocks with block size 6 were used for randomization.
Settings and conduct
Clinical trial in Shahid Shafiei and Sadoughi health centers in Yasouj is in the form of two intervention and control groups. The order of the researcher and the participants will be unaware of who is in which group until the beginning of the study. Intervention in this study from the age of 28 to 30 weeks of pregnancy, beginning and end of postpartum intervention The questionnaire that is completed at the beginning of the study (fear of childbirth Vijma version A) to study will be a pre-test for both intervention and control groups, then the intervention group and the control group in the same way using points False for two sessions of face-to-face training and 10 weeks of face-to-face training and follow-up, the researcher learns the technique of mind liberation.
Participants/Inclusion and exclusion criteria
include: Gestational age 28 to 30 weeks; primiparous; scoring more than 37 in the Vijama questionnaire
Exclusion : suffering from mental illness during the last year and taking psychotropic drugs
Intervention groups
Intervention group: tapping the parts of the face and body with the fingertips, which include: the beginning of the eyebrows, around the eyes, under the eyes, under the lips, chin, clavicle and armpits.
Control group: They also hit in the same way by using false points, ie points other than the points of the introduced acupressure.
Main outcome variables
Fear of childbirth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210622051671N1
Registration date:2021-07-31, 1400/05/09
Registration timing:registered_while_recruiting
Last update:2021-09-29, 1400/07/07
Update count:2
Registration date
2021-07-31, 1400/05/09
Registrant information
Name
Fatemeh Emadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5351 5216
Email address
emadi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-24, 1400/05/02
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Emotional Freedom Technique on fear of childbirth in nulliparous women
Public title
The effectiveness of Emotional Freedom Technique on fear of childbirth in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum primary education
Gestational age 28 to 30 weeks
Nulliparous
Earn more than 37 points in the Vijama questionnaire
Exclusion criteria:
Chronic diseases such as heart disease, high blood pressure, diabetes
History of abortion
Placenta previa
Suffering from mental illness during the last year and taking psychotropic drugs
Drug and smoking addiction
Pregnancy complications such as preeclampsia, bleeding, intrauterine death, preterm delivery
Age
From 15 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning the intervention to individuals is random and in the method of random permutation blocks with block size 6 (using the table related to random permutations) and with a ratio of 1: 1. The randomization list is prepared by a statistician. The codes assigned to the eligible individuals will be placed in sealed envelopes by an out-of-study person who is unaware of the research objectives and will be provided to the secretary of the clinic. They will not know who is in which group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The codes assigned to the eligible individuals will be placed in sealed envelopes by an out-of-study person who is unaware of the research objectives and will be provided to the secretary of the clinic. They will not know who is in which group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan St., Ahvaz Jundishapur University of Medical Sciences, Razi School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2021-06-15, 1400/03/25
Ethics committee reference number
IR.AJUMS.REC.1400.192
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Fear of childbirth score in Vijma childbirth fear questionnaire
Timepoint
At the beginning of the study (before the intervention) with Vijma Maternity Fear Questionnaire version A and at the end of the intervention (first postpartum visit) with Vijama Maternity Fear Questionnaire version B
Method of measurement
Vijma Childbirth Fear Questionnaire version A and B
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tapping the parts of the face and body with the fingertips, which include: the beginning of the eyebrows (above the nose), the sides of the eyes (on the outer bone of the eye), the under eyes (on the cheeks and 2-3 cm Meters below the eye socket), under the lips (in the short distance between the nose and the upper lip), chin (in the middle of the distance between the chin and the lower lip), clavicle (from the U-shaped bone below the throat 2-3 cm down and 2-3 cm Meters to the sides) and armpits (10 cm below the armpits).
Category
Other
2
Description
Control group: This group also strikes with their fingers using false points, ie points other than the points of acupressure introduced.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers 2 and 3 west of Ahvaz
Full name of responsible person
Khadijeh Hekmat
Street address
The end of Bani Hashem street, South Soroush street - the end of Kian, the first of Alavi alley, corner of Farahani
City
Ahvaz
Province
Khouzestan
Postal code
7591615786
Phone
+98 61 3379 6534
Email
Hekmat1346@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kourosh Zarea
Street address
Golestan Road, Shahr-e-Daneshgahi, Ahvaz School of Nursing and Midwifery, Vice Chancellor for Research, Second Floor
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8395
Email
zarea_k@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
Seyedeh Fatemeh Emadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan St., Razi School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135733337
Phone
+98 61 3373 8331
Email
s.fatemehemadi74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Khadijeh Hekmat
Position
science Committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan St., Razi School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135733337
Phone
+98 61 3373 8331
Email
Hekmat1346@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Emadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan St., Razi School of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135733337
Phone
+98 61 3373 8331
Email
s.fatemehemadi74@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