Protocol summary

Study aim
Determining the effect of distant fathers counseling on spouse social support and quality of life after childbirth in nulliparous women Determining and comparing the quality of life after childbirth in the control and intervention groups
Design
Simple 4.way random blocking 261
Settings and conduct
Comprehensive health centers of Qazvin making educational videos and textual content and images available in the form of 5 virtual sessions twice a week with fathers
Participants/Inclusion and exclusion criteria
Inclusion criteria: Noli Par women located in 34 to 36 weeks of pregnancy Married The desire of the wife and her husband to participate in the study Literacy of spouses Internet access Smart phone access Having the answering phone number of the lady and her husband Exclusion criteria: Existence of physical and psychological problems in the wife and her husband based on self.expression Taking medications to treat psychological disorders and the birth of a baby before the end of the fathers' training course
Intervention groups
Counseling sessions in the form of questions and answers, making educational videos and textual content and images available in the form of 5 virtual sessions will be provided to fathers twice a week. Then, on the day of delivery or discharge from the hospital, the fathers will be contacted again and the taught materials will be reminded briefly, and on the third to fifth days of delivery, if there are any problems or questions, a counseling session will be held for the fathers again. will be. Before the counseling sessions, the mothers of the intervention and control group will be asked to complete the social and fertility profile questionnaires (by sending a link to the WhatsApp application)
Main outcome variables
Primary outcome: Social support of the spouse after childbirth Quality of life after childbirth Secondary consequence: Postpartum fatigue

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211206053295N1
Registration date: 2022-02-05, 1400/11/16
Registration timing: registered_while_recruiting

Last update: 2022-02-05, 1400/11/16
Update count: 0
Registration date
2022-02-05, 1400/11/16
Registrant information
Name
Nazanin Shakibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4325 4022
Email address
nazaninshakibi12345@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2022-01-15, 1400/10/25
Expected recruitment end date
2023-05-15, 1402/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of fathers tele Counseling on spouse social support and post partum quality of life in primiparous women
Public title
Investigating the Effect of Fathers tele Counseling on spouse social support and post partum quality of life in primiparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Noli Par women located in 34 to 36 weeks of pregnancy Married The desire of the wife and her husband to participate in the study Literacy of spouses Internet access Smart phone access Having the answering phone number of the lady and her husband
Exclusion criteria:
Existence of physical and psychological problems in the wife and her husband based on self.expression Taking medications to treat psychological disorders and the birth of a baby before the end of the fathers' training course
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 122
Randomization (investigator's opinion)
Randomized
Randomization description
In order to use the 4.way random blocking method, one letter is assigned to each group (A: group by remote intervention method, B: control group). All possible modes for 4 blocks are written and numbered. Then, in a simple random method (using a table of random numbers), a number of numbers are selected from the block numbers and by writing the contents of those numbers (until the specified sample size is obtained ), The random allocation sequence is specified. For example, if the numbers obtained are 3, 2, 2, 1, etc., respectively, the assignment sequence will be as follows: AABB ABAB ABAB BBAA Then, in order to hide the allocation sequence, the sequence is written down on paper and placed in opaque sealed envelopes. Envelopes are numbered sequentially. Questionnaires are coded in the same way. In this case, a questionnaire with the same code will be completed for the person who receives the intervention code 1. The assignment sequence and its concealment will be done by someone outside the research team.
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 Qazvin University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, University of Medical Sciences, Bahonar Blvd, Qazvin, IRAN.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2022-01-15, 1400/10/25
Ethics committee reference number
IR.QUMS.REC.1400.402

Health conditions studied

1

Description of health condition studied
Social health and quality of life after childbirth
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Social Support Of the Spouse After Childbirth and Quality of Life After Childbirth
Timepoint
Intervention Group: 5 Virtual Sessions Twice a Week and One Session With an Interval of 1 to 6 Weeks Depending on the Time of Delivery. Control group: They fill in the questionnaires on the 3rd, 10th and 30th days after delivery.
Method of measurement
Spouses Social Support Questionnaires.Demographic.Visual Scale of Postpartum Fatigue and Postpartum Quality of Life

Secondary outcomes

1

Description
Postpartum fatigue
Timepoint
18 months
Method of measurement
Visual scale of postpartum fatigue

Intervention groups

1

Description
Intervention group: Pregnant mothers choose Noli Pari who come for pregnancy care at 34 to 36 weeks and after explaining the objectives of the study, they are asked to establish a communication between the researcher and their spouses if their spouses wish to participate in the study. Then, counseling sessions in the form of questions and answers, making educational videos and textual content and images available in the form of 5 virtual sessions will be provided to fathers twice a week. Then, on the day of delivery or discharge from the hospital, the fathers will be contacted again and the taught materials will be reminded briefly, and on the third to fifth days of delivery, if there are any problems or questions, a counseling session will be held for the fathers again. will be. Before the counseling sessions, the mothers of the intervention and control groups will be asked to complete the Social Profile and Fertility Questionnaires (by sending a link to the WhatsApp application).The opportunity to send the details is 2 days from the time of obtaining written consent.
Category
Rehabilitation

2

Description
Control group: Mothers in the control group will be asked to submit a questionnaire on the 3rd, 10th and 30th days after delivery of the personal and social characteristics questionnaire, baby characteristics, quality of life after delivery,Postpartum Spouse Social Support Questionnaire, Complete the postpartum fatigue scale.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin Health Centers
Full name of responsible person
Nazanin Shakibi
Street address
University Headquarters No. 2, Corner of Shahid Mofteh St, Azadegan Blvd, Qazvin.IRAN
City
َQazvin
Province
Qazvin
Postal code
5313534148
Phone
+98 28 3367 0031
Fax
Email
health@qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology of Qazvin University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, University of Medical Sciences, Bahonar Blvd, Qazvin, IRAN
City
Qazvin
Province
Qazvin
Postal code
3781833641
Phone
+98 28 3335 7039
Email
internationalaffairs@qums.ac.ir
Web page address
https://qums.ac.ir/en-US/qums.ac/9581/page/%D8%AA%D9%85%D8%A7%D8%B3-%D8%A8%D8%A7-%D9%85%D8%A7-
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Nazanin Shakibi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Qazvin University of Medical Sciences, Shahid Beheshti Blvdm, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3781833641
Phone
+98 28 3335 7039
Email
nazanishakibi12345@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nazanin Shakibi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Qazvin University of Medical Sciences, Shahid Beheshti Blvdm, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3781833641
Phone
+98 28 3335 7039
Email
nazaninshakibi12345@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nazanin Shakibi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Qazvin University of Medical Sciences, Shahid Beheshti Blvdm, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3781833641
Phone
+98 28 3335 7039
Email
nazaninshakibi12345@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
None of the personal information of the samples is available and only the results of the study are available to everyone.
When the data will become available and for how long
18 months after starting the study
To whom data/document is available
Anyone interested can access it.
Under which criteria data/document could be used
Only study variables are allowed on the data provided by the samples.
From where data/document is obtainable
Pregnant mothers 34-36 weeks referring to health centers in Qazvin
What processes are involved for a request to access data/document
1 writing proposal 2 months 2 Executive steps of approval in the University Research Council and the Ethics and Registration Committee in IRCT 3 months 3 sampling 6 months 4 Data extraction and analysis 1 month 5 Summarize and submit the final report in 1 month 6 Preparation of initial draft of the article and 5 months submission
Comments
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