The effect of supportive- educational counseling with men on distress of their pregnant wives: A randomized controlled clinical trials.
Design
To assign the participants to the study groups, the random block method will be used with blocks of 4 and 6 and with an allocation ratio of 1:1.Allocation of people in the study and control groups will be done by a person not involved in the project.
Settings and conduct
Considering the importance of the role of spouses in the pregnancy process and the importance of women's health during pregnancy this study was carried out in a quarter of the health centers (total of 84 centers) of Tabriz health centers that were randomly selected using selected from the website www.random.org, will be executed.
Participants/Inclusion and exclusion criteria
Inclution criteria: Gestational age 18 to 24 weeks, husband's willingness to participate, couple's literacy, not taking antidepressants and sedatives, no accidents during the last 6 months, people with a distress score of 24 or higher.
exclusion criteria: having obstetrical problems
Intervention groups
Intervention group: Educational counseling will be done for the intervention group. In this regard, 4 counseling sessions of 45 to 60 minutes will be held at intervals of one week in groups of 8 to 10 people. In all counseling sessions, only fathers will be present,Allocation of people in the study and control groups will be done by a person not involved in the project.Allocation of people in the study and control groups will be done by a person not involved in the project. The place and time of educational counseling will be based on the desire of the participants.
Control group: No special intervention will be done. After the study is completed, the counseling content will be given to the control group in the form of a booklet.
Main outcome variables
distress of pregnant wemen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110524006582N38
Registration date:2023-03-11, 1401/12/20
Registration timing:prospective
Last update:2023-03-11, 1401/12/20
Update count:0
Registration date
2023-03-11, 1401/12/20
Registrant information
Name
Mahin Kamalifard
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 414796770
Email address
kamalifardm@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2024-04-02, 1403/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supportive- educational counseling with men on distress of their pregnant wives: A randomized controlled clinical trials..
Public title
The effect of supportive- educational counseling with men on distress of their pregnant wives.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnancy age 18 to 24 weeks
husband's desire to participate in counseling classes
husbands' reading and writing literacy
Not taking antidepressants and sedatives
No accidents during the last 6 months
People with a distress score of 24 and above
Exclusion criteria:
Having an obstetric problem including the possibility of premature birth, diabetes, hypertension
Known congenital abnormalities
Receiving counseling services outside the study by couples before the study
Twins
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done after obtaining the necessary permits. A quarter of the health centers (a total of 84 centers) will be randomly selected using the www.random.org website.Since the sampling is multi-stage, first the health centers will be randomly selected, in this way, we number the centers from 1 to 84 and in the random.org software, we order a random selection of a quarter, the numbers selected in The list will show randomly selected centers. From the selected centers, sampling will be done in an easy way, then participants will be assigned to study groups (supportive counseling with fathers and control group).Random block method will be used for the random allocation of the study subjects using RAS software and through blocks of four and six and with an allocation ratio of 1:1. Allocation of people in the study and control groups will be done by a person not involved in the project. In order to hide the allocation (allocation concealment), the type of intervention will be written by a person not involved in the study in a paper and placed inside numbered opaque envelopes. After obtaining informed consent, the relevant envelope will be opened in the order of entry into the study and the intervention will be implemented.
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 Research in Tabriz University of Medical Sciences
Street address
Central Organization No. 2 - Vice Chancellor for Research TABRIZ, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2023-02-18, 1401/11/29
Ethics committee reference number
IR.TBZMED.REC.1401.907
Health conditions studied
1
Description of health condition studied
distress of pregnant wemen
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders
Primary outcomes
1
Description
The amount of distress of pregnant women
Timepoint
Before and 4 weeks after the study
Method of measurement
Tilberg Pregnancy Distress Scale Questionnaire
Secondary outcomes
1
Description
The amount of violence among pregnant women
Timepoint
four weeks after the end of the intervention in two intervention and control groups
Method of measurement
Questionnaire of conflict resolution strategy scale used for domestic violence
Intervention groups
1
Description
Intervention group: Educational counseling will be done for the intervention group. In this regard, 4 counseling sessions of 45 to 60 minutes will be held at intervals of one week in groups of 8 to 10 people. The counseling will be in Azeri language. In all counseling sessions, only fathers will be present. The place and time of educational counseling will be based on the desire of the participants.The contents of counseling sessions include: introduction, stating the goals of the plan, listening to clients, paying attention to the main point of problems and mental conflicts and listening to their opinions, the concept of supportive educational counseling and the impact of distress on the mother and fetus during pregnancy.The role of the father in supporting the pregnant mother, expressing the complications of the lack of support for pregnant women and its consequences after birth, the importance of the role of fathers during pregnancy, the importance of the father's bond with the fetus and the duties of fathers during pregnancy and childbirth, sexual relations and the changes surrounding it in Pregnancy, mental health during pregnancy,Violence in pregnancy and its effects on the mother and the fetus and the distress of the pregnant woman, anatomical, physiological and hormonal changes during pregnancy and the impact of these changes on the body and especially the mother's psyche and providing solutions to adapt more to these changes, the role of the father in helping the mother adapt With these changes, familiarity with the stages of fetal development during pregnancy, the effect of mother's nutrition and the father's attention to the nutrition of his pregnant wife and his wife's distress during pregnancy and the effect of prenatal care on the health of the mother and fetus, signs and symptoms of violence during pregnancy and how to deal with them,The process of childbirth and the stages of childbirth (natural cesarean) and the advantages and disadvantages of each, how the father and his pregnant wife prepare for childbirth will be described.The last fifteen minutes of each session will be devoted to questions and answers, and at the end of the session, individual counseling will take place if requested by each participant.
Category
N/A
2
Description
Control group: The content of the consultation will be provided to the control group in the form of a booklet.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz health centers
Full name of responsible person
Mahin Kamalifard
Street address
Shariati street, Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 0648
Fax
+98 41 3479 6969
Email
nursing@tbzmed.ac.ir
Web page address
https://nursing.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research office, No 2 central building, Golgasht street, Tabriz university of medical science riz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3335 9680
Email
research-vice@tbzmed.ac.ir
Web page address
https://www.tbzmed.ac.ir/
Grant name
Grant code / Reference number
دانشگاه علوم پزشکی تبریز
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Tabriz University of Medical Sciences
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, Shariati Ave Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 0364
Fax
+98 41 3479 6969
Email
kamalifardm@gmail.com
Web page address
https://nursing.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, Shariati Ave Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 0364
Fax
+98 41 3479 6969
Email
kamalifardm@tbzmed.ac.ir
Web page address
https://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahin Kamalifard
Position
assistant professor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing & Midwifery, Shariati street Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
kamalifardm@tbzmed.ac.ir
Web page address
https://nursing.tbzmed.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