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
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180408039229N2
Registration date:2021-03-23, 1400/01/03
Registration timing:registered_while_recruiting
Last update:2021-03-23, 1400/01/03
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
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of husbands' attendance in the labor on father's role adaptation
Public title
The effect of husbands' attendance in the labor on father's role adaptation
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,
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
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
2020-10-20, 1399/07/29
Ethics committee reference number
IR.GOUMS.REC.1399.231
Health conditions studied
1
Description of health condition studied
Father's role
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
Secondary outcomes
1
Description
Marital satisfaction
Timepoint
Two month after delivery
Method of measurement
Enrich marital satisfaction
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 Hoseini
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?