Determining the effect of learning paternal role on paternal fetal attachment to first time fathers
Design
One clinical trial with control and intervention group, one blind (participants are not aware of the allocation to the intervention and control group), randomized, interventions for seven weeks in fifty one individuals in the intervention group
Settings and conduct
The study will be conducted as a clinical trial on 102 fathers whose husbands will be referred to comprehensive health centers for routine care. 51 Fathers will be randomly assigned to the control group and 51 other parents in the intervention group. Fathers will attend two face-to-face (In-person) training session and five-week not in-person (by smartphone) courses on paternal role, then they will be evaluated by the Cranelly and Weaver parenal fetal attachment questionnaire at the beginning and end of the work.
Participants/Inclusion and exclusion criteria
Fathers await the first child whose wives will be referred to selected health care centers for routine pregnancy care at the gestational age of 28 to 32 weeks.
Intervention groups
The intervention group on paternal role (including attachment behaviors, marital relationships, modern paternity, self-knowledge, etc.) will be trained. Ultimately, the impact of educational sessions on the attachment score will be measured.The control group will not receive any training.
Main outcome variables
paternal fetal attachment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190311043017N1
Registration date:2019-05-08, 1398/02/18
Registration timing:registered_while_recruiting
Last update:2019-05-08, 1398/02/18
Update count:0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Nadia Hajirahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3285 4496
Email address
hajirahimi.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of learning father's role on paternal-fetal attachment in men who are the first to become dad
Public title
The effect of learning father's role on paternal-fetal attachment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All men who are the first to become dad
The first marriage
Living with spouse
Having a business
Planned pregnancy
It Have at least reading and writing skills
Access to smart phones
Exclusion criteria:
Presence of high-risk pregnancy on the basis of national guidelines
Having depression and a known psychological illness and use of antidepressants According to Said the person himself
To be enrolled In physiological delivery classes
Addiction to alcohol and drugs
History of infertility
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
First, using the random numbers table, the sample size is selected from pregnant women of 28 to 32 weeks, then divided into two groups of intervention and control in closed packets.Of the 102 envelopes in the package, 51 of them are numbered 1 and 51 are the number 2. The packs are mixed together so that even the researcher does not know their content. Then the couples are asked to select the envelope, those with their envelopes containing the number 1 will be in the control group and the couples that have the number 2 in the group Will intervene (we will pay attention to the fact that due to the different types of routine training given in each center and in order to match, be sure to have equal numbers of control and intervention from each center)
Blinding (investigator's opinion)
Single blinded
Blinding description
After couples choose the envelopes, the control group members receive only routine care and only participate in the previous and next examinations, but the intervention group receives the necessary training
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofurmia University of Medical Sciences
Street address
Emergency alley,resalat Blvd,urmia
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.UMSU.REC.1397.102
Health conditions studied
1
Description of health condition studied
paternal role
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
paternal-fetal attachment Score in Cranelly & Weaver Questionnaire
Timepoint
Completion of Cranelly & Weaver questionnaire at the beginning of the study (before the intervention) and the end of the intervention
Intervention group:Fathers present in the intervention group are divided into 3 groups of 17 people. The fathers will be trained in two sessions of two hours at the beginning and the end of the intervention about attachment to their fetus and their respective skills.. In the intervals of these meetings, fathers will be trained on the paternal role for five weeks through a popular communication application in the country via smartphones..
Category
Lifestyle
2
Description
Control group: The fathers of the control group will have only one session at the start of the intervention to complete the satisfaction(Consent form) and questionnaire, but they will receive no training. At the end of the intervention, the fathers of the control group will complete a questionnaire through a telephone call.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia comprehensive health centers
Full name of responsible person
NadiaHajirahimi
Street address
Facing the mosque Qaba., Shahid Beheshti Ave
City
Urmia
Province
West Azarbaijan
Postal code
44437 - 57159
Phone
+98 44 3346 6800
Email
phc_riasat@umsu.ac
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebi
Street address
Emergency alley,resalat Blvd,urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
library@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
NadiaHajirahimi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Bostan dormitory., Zakir street
City
Urmia
Province
West Azarbaijan
Postal code
5716762575
Phone
+98 25 3285 4496
Email
hajirahimi.n@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nadia Hajirahimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kampozitapartment،No.9, Valiasr Ave., Qods Town
City
Qom
Province
Ghoum
Postal code
57167-62575
Phone
+98 25 3285 4496
Fax
Email
hajirahimi.n@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Nadia Hajirahimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kampozitapartment،No.9, Valiasr Ave., Qods Town
City
Qom
Province
Ghoum
Postal code
57167-62575
Phone
+98 25 3285 4496
Fax
Email
hajirahimi.n@umsu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available