Protocol summary

Summary
The main aim of this research is studying the effectiveness of couples training program based on Basnef model on spouses support ans pregnant women s mental health . specific gouls indude : comparing women s mental health before and after training in intervention and control groaps , and comparing the elements of Basnet model such as knowledy , attitude , abstract norm , the factors needed in enabling couples from spooses support and pregnant women s mental health in intervention and control groups . before and after training . Design : this study is a semi – experimental study . method : the aime of study is presented to couples by researches and after cooperation request , iniviting spouses , and reciciving poper of coxsent , participants enter to the study . the invironment of research is health care centers of hormozgan university of medical science in bandar abbas city . the centers selected by cluster random sampling in such away that health care centers of Bandar abbas city are listed and for centers are selected by random sampling among which two centers are chosen to perfrom couple traning plan , and two other are set as control centers . than 63 couples of these two centers are selected to receive traning . the couple selection is done in a constand and accessible way. Receiving criteria include : all pregnant women and their apouses referring to the health care centers of Bandar abbas;. gestational age range is 20-30 weeks;. fetus is confirmed by sonography;. absence of intimates death daring the past one year;. delivery criteria include : taking anti – depressant mediactions;. fetus death;. renunciation or dropping out of study; . the interventions based on basnef model include :60 minutes face training for 4 sessions in the heath cave centers , together with distributing educational hand book and sending a reminder message to spouses once a week. Major outcome variable : studying the effectiveness of couple training pragroam based on basnef model an spouses support and onseunetially on pregnant women s mental health .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201301196284N6
Registration date: 2014-12-30, 1393/10/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-30, 1393/10/09
Registrant information
Name
Maryam Modarres
Name of organization / entity
Tehran university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 8142
Email address
modarres@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-05-10, 1393/02/20
Expected recruitment end date
2014-08-11, 1393/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of couples educational program based basnef model on spouse support and mental health of pregnant women
Public title
Mental Health- Spouse Support- Basnef Model
Purpose
Prevention
Inclusion/Exclusion criteria
receiving criteria include : all pregnant women and their spouses referring to the heath cove center of Bandar abbas;. gestakonal age range is 20-30 wels;. fetus health is confirmed by sonography ;. absence of intimates death during the past one year;. delivery criteria include : taking anti depressant medications;. fetus death ;. renunciation or dropping out of study;.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 125
Randomization (investigator's opinion)
Randomized
Randomization description
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 Tehran University of Medical sciences
Street address
f 6th, Center organization of university, edge of Qods avenue, Keshavarz blvd
City
Tehran
Postal code
1419733171
Approval date
2014-10-29, 1393/08/07
Ethics committee reference number
1851/130/ص/93

Health conditions studied

1

Description of health condition studied
Mental health
ICD-10 code
F00-F09,F1
ICD-10 code description
Mental and behavioural disorders

Primary outcomes

1

Description
Mental health
Timepoint
Before intervention - 4 weeks after intervention
Method of measurement
Mental health assessment Questionnaire 28

2

Description
Spouse support
Timepoint
Before intervention- 4 weeks after intervention
Method of measurement
Spouse support questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Educational on Basnef model once a week for 4 weeks, and distribution of educational booklets and texting once a week
Category
Behavior

2

Description
Control group: routine prenatal care
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center number (7) in Bandarabas
Full name of responsible person
Azam Moridi
Street address
Health Center number (7), adjacent to Lyla hospital, Bandarabas
City
Bandarabas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical sciences
Full name of responsible person
Research assistant of Tehran University of Medical sciences( Dr Yonessian Massoud)
Street address
5th floor,Central building of Tehran University of Medical sciences, edge of Qods Av, Keshavarz blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Modares Maryam
Position
Phd Medical education
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery Tehran University of Medical Science, Tohid square
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
modarres@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr. Modares Maryam
Position
Phd Medical education
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery Tehran University of Medical Science, Tohid square
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
modarres@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hormozgan University of Medical Science
Full name of responsible person
Moridi Azam
Position
Masters
Other areas of specialty/work
Street address
Alley, 22 Bahman , 3 Kosar streets Deputy of Hormozgan University of Medical Sciences
City
Bandarabas
Postal code
7918813175
Phone
+98 917 367 2157
Fax
Email
azammoridi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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