Protocol summary

Summary
Objective: This study is to determine the effect of life skills counselling on Marital Satisfaction among primigravida women. This study is a semi experimental with two groups (experimental and control) with pre-test and post-test. This study comprised pregnant women attending to health care centers in Asadabad. Simple randomization will be done. The sample size is 32 women in the intervation group and 32 women in control group. Inclusion criteria: First pregnancy; gestational age 16-24 weeks; Enrich marital satisfaction questionnaire score below 60.Exclusion criteria: Any problems in pregnancy during the study period. In the intervention group life skills counseling will be trained by the researcher in 8 sessions. and the control group took routine prenatal care. In this study primary outcome measure is Marital Satisfaction and secondary outcome measure is life skills counseling

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015030215341N4
Registration date: 2015-10-25, 1394/08/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-10-25, 1394/08/03
Registrant information
Name
Batul Khodakarami
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0447
Email address
khodakaramy@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research Technolog, Hamedan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
The effect of life skills counseling on marital satisfaction in Nulliparous pregnant women attending to the cillinics of Asadabad in 2015
Public title
The effect of life skills counseling on marital satisfaction in Nulliparous pregnant women attending to the cillinics of Asadabad in 2015
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: first pregnancy; gestational age 16-24 weeks; not being addicted; not taking antidepressants; Enrich marital satisfaction questionnaire score below 60; not having physical and mental disorders, according to the pregnancy records. Exclusion criteria: any problems in pregnancy during the study period; major mental and emotional changes (such as death or serious disputes).
Age
From 15 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
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 Hamadan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmide St., Hamedan
City
Hamadan
Postal code
65178
Approval date
2015-09-26, 1394/07/04
Ethics committee reference number
IR.UMSHA.REC.1394.297

Health conditions studied

1

Description of health condition studied
The effect of life skills counseling on marital satisfaction in Nulliparous pregnant women
ICD-10 code
Z34.8
ICD-10 code description
Supervision of other normal pregnancy

Primary outcomes

1

Description
Marital Satisfaction
Timepoint
Before intervention ,4 and 8 week after intervention
Method of measurement
Enrich marital satisfaction questionnaire

Secondary outcomes

1

Description
life skills
Timepoint
Before intervention ,4 and 8 week after intervention
Method of measurement
Checklist

Intervention groups

1

Description
Intervention group: providing life skills counseling to pregnant women by midwives with group counseling approach.Counseling sessions 8 sessions of 60 minutes for groups of pregnant women is 11 members. .During this Intervention Pamphlet will be placed in Intervation test
Category
Prevention

2

Description
Control group: regular prenatal care
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic number 1
Full name of responsible person
Batul Khodakarami
Street address
Imam Khomeini Square
City
Asadabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of Research Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr. Bashirian Saeed
Street address
Hamedan University of Medical Sciences, Shahid Fahmide St., Hamedan
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research Technology, Hamadan 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
Hamedan University of Medical Sciences
Full name of responsible person
Batul Khodakarami
Position
Master of Science, Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmide St., Hamedan
City
Hamedan
Postal code
65178
Phone
+98 81 3838 0150
Fax
+98 81 3838 0447
Email
khodakaramy@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Batul Khodakarami
Position
Master of Science, Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmide St., Hamedan
City
Hamedan
Postal code
65178
Phone
+98 81 3838 0150
Fax
Email
khodakaramy@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Roya Asadi
Position
Bachelor Of Midwifery/ Student Of Master of Midwifery Counseling
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmide St., Hamedan
City
Hamedan
Postal code
Phone
+98 81 3256 7022
Fax
Email
royaasadi044@gmail.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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