Protocol summary

Summary
This study is a randomized clinical trial. The aim of this study is to evaluate the effect of problem solving skill education on the type and severity of domestic violence among pregnant women who has experienced domestic violence. The study population is all pregnant women who have study include criteria and attend prenatal care units of health care centers affiliated to Tehran University of Medical Sciences. Sample size is 400 pregnant women. Sampling method is stratified cluster sampling and randomly from each center two clinic will be selected for intervention and control groups. First, the researcher provides pregnant women with screening forms of domestic violence and after reviewing the forms women who has experienced violence will be identified and randomly enter to the study. With a phone call they will be requested to participate in a briefing then the demographic, maternal history and problem solving questionnaire will complete separately in control group and intervention group. Researcher asks control group to refer for completing the problem solving questionnaire and screening form of domestic violence after three months. in intervention group, by considering everyone’s agreement, proper time for holding four sessions of problem solving skill education will be appointed. A group education entitled problem solving skill education for pregnant women including 4 sessions during 4 weeks (each week a session) will be held. Each session is about 60 minutes, first 45 minutes for the education and last 15 minutes for questions and answers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013041713046N1
Registration date: 2013-08-29, 1392/06/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-29, 1392/06/07
Registrant information
Name
Maryam Puorbakhtiar
Name of organization / entity
Nursing and Midwifery College
Country
Iran (Islamic Republic of)
Phone
+98 31 2521 5411
Email address
m-porbakhtyar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Effect of problem-solving skills training on the type and severity of domestic violence in pregnant women abuse
Public title
Evaluation Effect of problem-solving skills on the domestic violence
Purpose
Prevention
Inclusion/Exclusion criteria
Include criteria: 1. All pregnant women in the first half of pregnancy. 2. To have Least literacy for reading and writing. 3. Pregnancy resulting from a formal marriage. 4. Not participating in a similar study. 5. Acquaintance with the Persian language. Exclusion criteria: 1. incidence of stressful events such as death or serious illness of one family member. 2. Unwillingness to continue participating in study. 3. More than one Absence from sessions. 4. Going to Counseling Centers during the study.
Age
From 16 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 400
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 Science
Street address
Vice Chancellor for Research,Tehran University of Medical Sciences. Ghods St. Keshavarz Bv.
City
tehran
Postal code
Approval date
2013-03-11, 1391/12/21
Ethics committee reference number
ندارد

Health conditions studied

1

Description of health condition studied
intimate partner physical violence
ICD-10 code
R45.6
ICD-10 code description
physical violence

2

Description of health condition studied
intimate partner psychological violence
ICD-10 code
T74.3
ICD-10 code description
psychological abuse

3

Description of health condition studied
intimate partner sexual violence
ICD-10 code
T74.2
ICD-10 code description
sexual abuse

Primary outcomes

1

Description
the type of domestic violence
Timepoint
Two months after intervention in intervention group and three months after beginning of study in control group
Method of measurement
CTS2 Questionnaire

2

Description
the severity of domestic violence
Timepoint
Two months after intervention in intervention group and three months after beginning of study in control group
Method of measurement
CTS2 Questionnaire

Secondary outcomes

1

Description
age
Timepoint
in beginning of intervention
Method of measurement
Demographic Information Questionnaire

2

Description
occupation
Timepoint
in beginning of intervention
Method of measurement
Demographic Information Questionnaire

3

Description
Education
Timepoint
in beginning of intervention
Method of measurement
Demographic Information Questionnaire

4

Description
Time of marriage
Timepoint
in beginning of intervention
Method of measurement
Demographic Information Questionnaire

5

Description
Socioeconomic
Timepoint
in beginning of intervention
Method of measurement
Demographic Information Questionnaire

Intervention groups

1

Description
Control group: Researcher after reviewing the of domestic violence screening forms identifies women who has experienced violence and randomly enters to the study and by a phone call invites them to a briefing session. In this session researcher introduces herself for study samples and explains the aims of study for them then takes their informed consent to participating in the study. after completing the demographic, maternal history and problem solving questionnaire, they will be asked to return three months later to complete problem solving questionnaire and screening form of domestic violence
Category
Prevention

2

Description
Intervention group: researcher after reviewing the of domestic violence screening forms identifies women who has experienced violence and randomly enters to the study and by a phone call invites them to a briefing session. In this session researcher introduces herself for study samples and explains the aims of study for them then takes their informed consent to participating in the study. after completing the demographic, maternal history and problem solving questionnaire, they will be asked to appoint Proper time for holding four sessions of problem solving skill education, by Considering everyone’s agreement. A group education Entitled problem solving skill education for pregnant women include 4 sessions will be held during 4 weeks (each week a session). Each session is about 60 minutes, first 45 minutes for the education and last 15 minutes for Questions and Answers. Content of problem solving educational program in this study is base on studies of Heydari & Rasoulzadeh Tabatabaie, and Akbari et all, and Dickson & glor. Researcher is about to review the past contents At the beginning of each session and use role playing and homework for the end. At the end of the forth session pregnant women will complete problem solving questionnaire again and Researcher asks them to return to health care centers for completing domestic violence screening forms after two months.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Health & Medical center South Tehran Shahid Ayat
Full name of responsible person
Street address
Opposite of shariati’s Park, shariati Town, mahan st, behind of padegane qaleh morqi, Tehran.
City
Tehran

2

Recruitment center
Name of recruitment center
Health & Medical center South Tehran Shahid Ahmadi
Full name of responsible person
Street address
koche baq, Crossroads salehnia, zamzam st, padegane qaleh morqi, Tehran
City
Tehran

3

Recruitment center
Name of recruitment center
Health & Medical Center South Tehran Mehregan
Full name of responsible person
Street address
Next to behzisti ardakan, The second line of rahahan Boulevard, qaleh morqi St, tehran
City
Tehran

4

Recruitment center
Name of recruitment center
Health & Medical center South Tehran Emam Sadeq
Full name of responsible person
Street address
town ahmadieh, kholazir, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Ziba Taghizadeh
Street address
Vice Chancellor for Research,Tehran University of Medical Sciences. Ghods St. Keshavarz Bv.
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 Sciences
Full name of responsible person
Maryam Porbakhtyar
Position
MSc student
Other areas of specialty/work
Street address
No: 19. East 4th .khaghani St .shahin shahr. esfahan
City
Isfahan
Postal code
Phone
+98 31 2521 5411
Fax
Email
m_poor_mw@yahoo.com; m-porbakhtyar@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
maryam porbakhtyar
Position
student of master of sciences
Other areas of specialty/work
Street address
19. East 4th. khaghani St. shahin shahr. Isfahan.
City
Isfahan
Postal code
Phone
+98 31 2521 5411
Fax
Email
m-porbakhtyar@razi.tums.ac.ir;m_poor_mw@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Porbakhtyar
Position
Student of Master of Sciences
Other areas of specialty/work
Street address
No: 19. East 4th .khaghani St .shahin shahr. esfahan
City
Isfahan
Postal code
Phone
+98 31 2521 5411
Fax
Email
m-porbakhtyar@razi.tums.ac.ir; m_poor_mw@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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