Protocol summary

Summary
Objectives: this study will be conducted to evaluate the effectiveness of teaching communication skills on marital satisfaction and mental health of pregnant women. Design: This quasi-experimental study will be performed in health centers Nawab, Isfahan, on 60 pregnant women with gestational age less than 24 weeks in two intervention and control groups, who had low marital satisfaction. The levels of anxiety, depression and marital satisfaction will be evaluated by using General Health Questionnaire and ENRICH marital satisfaction questionnaires before the start of the program and one and three months after the intervention. The intervention will be included communication skills training according to the needs of pregnant women during pregnancy. Main outcome measures: scores of marital satisfaction, depression, and anxiety will be evaluated in the intervention and control groups at interval of one month and three months after the intervention

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017012932264N2
Registration date: 2017-06-28, 1396/04/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-28, 1396/04/07
Registrant information
Name
Zahra Alipour
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7532
Email address
z_alipour@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2017-02-03, 1395/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of communication skills training on marital satisfaction and mental health among pregnant women
Public title
The effect of communication skills training on marital satisfaction
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Being married; having the ability to read and write; Not using antidepressants or any other psychiatric medications; no polygamous marriage; gestational age below 24 weeks; Marital satisfaction scores less than 28. Exclusion criteria: lack of participation in more than 30% of communication skills training classes; failure to complete the questionnaire.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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 Isfahan University of Medical Sciences
Street address
Faculty of Nursing &Midwifery, Isfahan University of Medical Sciences, Hezar-Jerib Ave, Azadi Square, Isfahan, Iran
City
Isfahan,
Postal code
8174673465
Approval date
2013-06-05, 1392/03/15
Ethics committee reference number
349394

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

2

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention, 1 and 3 months after intervention
Method of measurement
Through the General Health Questionnaire

2

Description
Depression
Timepoint
Before the intervention, 1 and 3 months after intervention
Method of measurement
Through the General Health Questionnaire

3

Description
Marital Satisfaction
Timepoint
Before the intervention, 1 and 3 months after intervention
Method of measurement
through enrich marital satisfaction scale

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: Communication skills training based on the changes of pregnancy in 7 sessions of 2 hours
Category
Behavior

2

Description
control group: Preparation for Childbirth classes in two sessions of two hours
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Nawab Safavi Community health center
Full name of responsible person
Dr.Sadeghian
Street address
Nawab Safavi Community health center, Bolts Ahmadabad, BozorgMehr Ave , Isfahan, Iran
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Mahdi Neematbakhsh
Street address
Vice chancellor for research, Isfahan University of Medical Sciences, , Hezar-Jerib Ave., Azadi Square, Isfahan, Iran
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ashraf Kazemi
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing &Midwifery, Isfahan University of Medical Sciences, Hezar-Jerib Ave, Azadi Square, Isfahan, Iran
City
Isfahan
Postal code
8174673465
Phone
+98 31 3792 7537
Fax
+883 136699398
Email
kazemi@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ashraf Kazemi
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing &Midwifery, Isfahan University of Medical Sciences, Hezar-Jerib Ave, Azadi Square, Isfahan, Iran
City
Isfahan
Postal code
8174673465
Phone
+98 31 3792 7537
Fax
+883 136699398
Email
kazemi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ashraf Kazemi
Position
Assistant Professor
Other areas of specialty/work
Street address
Faculty of Nursing &Midwifery, Isfahan University of Medical Sciences, Hezar-Jerib Ave, Azadi Square, Isfahan, Iran
City
Isfahan
Postal code
8174673465
Phone
+98 31 3792 7537
Fax
+98 31 3669 9398
Email
kazemi@nm.mui.ac.ir
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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