1. Home
  2. Approved trials
  3. » فارسی

the effect of spouse attendance in the labor on father's role adaptation and active phase duration

View the latest revision

History
# Registration date Revision Id
2 2022-08-02, 1401/05/11 240117
1 2021-03-23, 1400/01/03 176060
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    Determining the percentage of compliance with the paternal role in cases of presence or absence of the spouse during labor
    Determining the percentage of compliance with the paternal role in cases of presence or absence of the spouse during labor, Active phase duration
    تعیین درصد انطباق با نقش پدری در موارد حضور و عدم حضور همسر طی لیبر
    تعیین درصد انطباق با نقش پدری در موارد حضور و عدم حضور همسر طی لیبر، طول مدت فاز فعال زایمان

  • General information

    empty
    57
    empty
    2020-11-16, 1399/08/26
    empty
    2021-05-20, 1400/02/30
    empty
    2021-07-21, 1400/04/30
    empty
    Adding the active phase duration to intervention outcomes
    empty
    اضافه کردن طول فاز فعال زایمان به پیامدهای مداخله
    The effect of husbands' attendance in the labor on father's role adaptation
    The effect of spouse attendance in the labor on father's role adaptation and active phase duration
    تاثير حضور همسر در ليبر بر انطباق با نقش پدري
    تاثير حضور همسر در ليبر بر انطباق با نقش پدري و طول فاز فعال زایمان
    Investigating the effect of husbands' attendance in the labor on father's role adaptation
    the effect of spouse attendance in the labor on father's role adaptation and active phase duration
    بررسي تاثير حضور همسر در ليبر بر انطباق وي با نقش پدري
    بررسي تاثير حضور همسر در ليبر بر انطباق وي با نقش پدري و طول فاز فعال زایمان
    Married men,
    living in Kalaleh,
    Iranian citizenship,
    Ability to understand and speak, read and write in Persian,
    Experience becoming a father for the first time,
    Their wife's have normal vaginal delivery condition with GA 38-42 weeks,
    Presence behind her wife for at least 2 hours during labor,
    Married men,
    living in Kalaleh,
    Iranian citizenship,
    Ability to understand and speak, read and write in Persian,
    Experience becoming a father for the first time,
    Their wife's have normal vaginal delivery condition with GA 38-42 weeks,
    Presence behind her wife for at least 2 hours during labor,
    Hospitalization at the onset of active phase of labor
    مردان متاهل
    ساکن شهر کلاله
    تابعیت ایرانی
    توانایی درک و تکلم، خواندن و نوشتن به زبان فارسی
    تجربه پدر شدن برای اولین بار
    زایمان همسرانشان در سن حاملگی 42-38 هفته و دارای شرایط زایمان طبیعی
    حضور حداقل 2 ساعت در کنار همسر طی لیبر
    مردان متاهل
    ساکن شهر کلاله
    تابعیت ایرانی
    توانایی درک و تکلم، خواندن و نوشتن به زبان فارسی
    تجربه پدر شدن برای اولین بار
    زایمان همسرانشان در سن حاملگی 42-38 هفته و دارای شرایط زایمان طبیعی
    حضور حداقل 2 ساعت در کنار همسر طی لیبر
    بستری در آغاز فاز فعال زایمان

  • Ethics committees

    #1
    2020-10-20, 1399/07/29
    2020-10-18, 1399/07/27

  • Health conditions studied

    #1
    Father's role
    husbands' attendance in the labor
    نقش پدری
    حضور همسر در طی لیبر

  • Primary outcomes

    #1
    empty
    active phase duration
    empty
    طول مدت فاز فعال زایمان
    empty
    From the beginning of hospitalization in the active phase of labor every one hour until delivery
    empty
    از آغاز بستری در فاز فعال زایمان هر یکساعت تا زایمان
    empty
    Partograph form
    empty
    فرم پارتوگراف

  • Secondary outcomes

    #1
    Marital satisfaction
    empty
    رضایت زناشویی
    empty
    Two month after delivery
    empty
    دو ماه بعد از زایمان
    empty
    Enrich marital satisfaction
    empty
    پرسشنامه رضایت زناشویی انریچ
    empty

  • Recruitment centers

    #1
    Name of recruitment center - English: Kalaleh hospital
    Name of recruitment center - Persian: بیمارستان کلاله
    Full name of responsible person - English: Nahid Haji Hoseini
    Full name of responsible person - Persian: ناهید حاجی حسینی
    Street address - English: Al-Ghadir Square
    Street address - Persian: میدان الغدیر
    City - English: Kalaleh
    City - Persian: کلاله
    Province: Golestan
    Country: Iran (Islamic Republic of)
    Postal code: 4991844494
    Phone: +98 17 3544 7993
    Fax:
    Email: nahidhaji59@gmail.com
    Web page address:
    Name of recruitment center - English: Kalaleh hospital
    Name of recruitment center - Persian: بیمارستان کلاله
    Full name of responsible person - English: Nahid Haji Hosseini
    Full name of responsible person - Persian: ناهید حاجی حسینی
    Street address - English: Al-Ghadir Square
    Street address - Persian: میدان الغدیر
    City - English: Kalaleh
    City - Persian: کلاله
    Province: Golestan
    Country: Iran (Islamic Republic of)
    Postal code: 4991844494
    Phone: +98 17 3544 7993
    Fax:
    Email: nahidhaji59@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: honarvar, Mohammad Reza
    Full name of responsible person - Persian: دکتر محمد رضا هنرور
    Street address - English: Sayyad Shirazi Blvd.
    Street address - Persian: بلوار صیاد شیرازی
    City - English: Gorgan
    City - Persian: گرگان
    Province: Golestan
    Country: Iran (Islamic Republic of)
    Postal code: 4917977738
    Phone: +98 17 3254 9718
    Fax:
    Email: borghei2006@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Honarvar, Mohammad Reza
    Full name of responsible person - Persian: دکتر محمد رضا هنرور
    Street address - English: Sayyad Shirazi Blvd.
    Street address - Persian: بلوار صیاد شیرازی
    City - English: Gorgan
    City - Persian: گرگان
    Province: Golestan
    Country: Iran (Islamic Republic of)
    Postal code: 4917977738
    Phone: +98 17 3254 9718
    Fax:
    Email: borghei2006@yahoo.com
    Web page address:

Protocol summary

Study aim
The effect of husbands' attendance in the labor on adaptation to father's role
Design
In this study, available sampling will be selected from the clients of Rasoul Akram maternity hospital in Kalaleh. In such a way that the clients of Kalaleh maternity hospital will be examined during the days of the week from Saturday to Thursday if they wish to participate in the study. The clients should consider even days for the intervention group (A) and odd days for the control group (B).
Settings and conduct
Sampling will be selected from those referred to Rasoul Akram Hospital maternity hospital in Kalaleh The clients of Kalaleh maternity hospital will be examined during the days of the week from Saturday to Thursday if they wish to participate in the study, so that the clients have even days for the intervention group (A) and odd days for the control group (B). Will be considered
Participants/Inclusion and exclusion criteria
Iranian citizenship Ability to understand and speak, read and write in Persian Fetal health based on ultrasound and pregnancy tests The mother must have a normal delivery. Gestational age is 38-42 weeks of single pregnancy and live fetus. Becoming a father for the first time Wanted pregnancy The father should be with his wife for at least 2 hours during labor Exclusion criteria: Withdrawal from continuing to participate in the study Early cesarean section after entering labor
Intervention groups
fathers who for their wife's childbirth with 38-42 weeks gestational age and have normal delivery conditions will refer to Kalaleh Hospital and wish to be with their spouse for at least 2 hours as a active phase
Main outcome variables
Determining the percentage of compliance with the paternal role in cases of presence or absence of the spouse during labor, Active phase duration

General information

Reason for update
Adding the active phase duration to intervention outcomes
Acronym
IRCT registration information
IRCT registration number: IRCT20180408039229N2
Registration date: 2021-03-23, 1400/01/03
Registration timing: registered_while_recruiting

Last update: 2022-09-13, 1401/06/22
Update count: 1
Registration date
2021-03-23, 1400/01/03
Registrant information
Name
Narjes Sadat Borghei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 9718
Email address
dr.borghei@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
2020-11-16, 1399/08/26
Actual recruitment end date
2021-05-20, 1400/02/30
Trial completion date
2021-07-21, 1400/04/30
Scientific title
the effect of spouse attendance in the labor on father's role adaptation and active phase duration
Public title
The effect of spouse attendance in the labor on father's role adaptation and active phase duration
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Married men, living in Kalaleh, Iranian citizenship, Ability to understand and speak, read and write in Persian, Experience becoming a father for the first time, Their wife's have normal vaginal delivery condition with GA 38-42 weeks, Presence behind her wife for at least 2 hours during labor, Hospitalization at the onset of active phase of labor
Exclusion criteria:
Withdrawal of the spouse from participating in the prenatal study Early cesarean section after entering labor
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 58
Actual sample size reached: 57
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: block Randomization Random unit: Individual For random assignment of samples to the intervention and control groups, the quadratic block method with permutations (AABB-ABAB-ABBA-BABA-BAAB-BBAA) will be used. A represents the intervention group and B represents the control group. The blocks are randomly selected without placement and the samples will be assigned to groups according to their permutations.
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 Golestan University of Medical Sciences
Street address
Research Deputy of Golestan University of Medical Sciences, Beginning of the Road of Shasta Kalateh., 5th Km of Gorgan Kurdkuy Road
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-10-18, 1399/07/27
Ethics committee reference number
IR.GOUMS.REC.1399.231

Health conditions studied

1

Description of health condition studied
husbands' attendance in the labor
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Husbands' adaptation to father's role
Timepoint
Two month after delivery
Method of measurement
Father's role adaptation questionnaire

2

Description
active phase duration
Timepoint
From the beginning of hospitalization in the active phase of labor every one hour until delivery
Method of measurement
Partograph form

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: the presence of the husband will be require for at least two hours during active phase of labor.
Category
Behavior

2

Description
Control group: will not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kalaleh hospital
Full name of responsible person
Nahid Haji Hosseini
Street address
Al-Ghadir Square
City
Kalaleh
Province
Golestan
Postal code
4991844494
Phone
+98 17 3544 7993
Email
nahidhaji59@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Honarvar, Mohammad Reza
Street address
Sayyad Shirazi Blvd.
City
Gorgan
Province
Golestan
Postal code
4917977738
Phone
+98 17 3254 9718
Email
borghei2006@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Narjes Sadat Borghei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No. 2, Ahoo appartment., Sayade5., Sayad shirazy Blvd.,
City
Gorgan
Province
Golestan
Postal code
4917977738
Phone
+98 17 3254 9718
Fax
+98 17 3245 5171
Email
dr.borghei@goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narjes Sadat Borghei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
No. 2, Ahoo appartment., Sayade5., Sayad shirazy Blvd
City
Gorgan
Province
Golestan
Postal code
4917977738
Phone
+98 17 3254 9718
Fax
+98 17 3245 5171
Email
dr.borghei@goums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Nahid Haji Hosseini
Position
MS student of counseling Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Taleghani 4
City
Gonbad Kavous
Province
Golestan
Postal code
4991844494
Phone
+98 17 3544 2595
Email
nahidhaji59@gmail.com

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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data from the intervention and control groups can be published up to six months after the publication of the article
When the data will become available and for how long
Up to six months after the publication of the article
To whom data/document is available
Researchers who request in writing from the correspondence author
Under which criteria data/document could be used
systematic review
From where data/document is obtainable
correspondence author
What processes are involved for a request to access data/document
Send a written request to the email of the correspondence author up to six months after the publication of the article
Comments
Loading...