Protocol summary
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Study aim
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The effect of husbands' attendance in the labor on adaptation to father's role
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Design
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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).
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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Adding the active phase duration to intervention outcomes
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Acronym
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IRCT registration information
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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
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Registration date
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2021-03-23, 1400/01/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-11-21, 1399/09/01
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Expected recruitment end date
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2021-06-20, 1400/03/30
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Actual recruitment start date
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2020-11-16, 1399/08/26
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Actual recruitment end date
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2021-05-20, 1400/02/30
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Trial completion date
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2021-07-21, 1400/04/30
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Scientific title
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the effect of spouse attendance in the labor on father's role adaptation and active phase duration
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Public title
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The effect of spouse attendance in the labor on father's role adaptation and active phase duration
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
58
Actual sample size reached:
57
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-10-18, 1399/07/27
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Ethics committee reference number
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IR.GOUMS.REC.1399.231
Health conditions studied
1
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Description of health condition studied
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husbands' attendance in the labor
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Husbands' adaptation to father's role
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Timepoint
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Two month after delivery
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Method of measurement
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Father's role adaptation questionnaire
2
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Description
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active phase duration
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Timepoint
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From the beginning of hospitalization in the active phase of labor every one hour until delivery
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Method of measurement
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Partograph form
Intervention groups
1
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Description
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Intervention group: the presence of the husband will be require for at least two hours during active phase of labor.
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Category
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Behavior
2
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Description
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Control group: will not receive any intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Gorgan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Data from the intervention and control groups can be published up to six months after the publication of the article
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When the data will become available and for how long
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Up to six months after the publication of the article
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To whom data/document is available
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Researchers who request in writing from the correspondence author
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Under which criteria data/document could be used
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systematic review
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From where data/document is obtainable
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correspondence author
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What processes are involved for a request to access data/document
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Send a written request to the email of the correspondence author up to six months after the publication of the article
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Comments
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