Determining the Effect of Problem-Based Group Counseling on the Experience of Domestic Violence in Pregnant Mothers
Design
The clinical trial study included a control group. Each group consisted of 40 pregnant women exposed to violence who were randomly assigned to a non-placebo-controlled draw
Settings and conduct
This study was performed at the Buin Zahra Urban Integrated Health Service Centers. After reviewing the mothers' electronic records, mothers who meet the inclusion criteria will be selected and the cts2 questionnaire will be completed. The mothers were then randomly assigned into two groups of 40 each. The intervention group consisted of 6 45-minute group counseling sessions per week.
Participants/Inclusion and exclusion criteria
18 to 35 years with 10 to 30 weeks gestation; no mental illness; no infertility treatment; no stressful couple life
Intervention groups
Hold 6 45-minute group counseling sessions for intervention group one session per week, if the control group results are effective, they will receive similar interventions
Main outcome variables
Violence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191022045202N1
Registration date:2019-10-31, 1398/08/09
Registration timing:registered_while_recruiting
Last update:2019-10-31, 1398/08/09
Update count:0
Registration date
2019-10-31, 1398/08/09
Registrant information
Name
Masoumeh Alamshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3422 8606
Email address
m.alamshahi@qumc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group Counseling Based Problem-Solving Advice on the Experience of Domestic Violence in Pregnant Women
Public title
The Effect of Group Counseling Based Problem-Solving Advice on the Experience of Domestic Violence in Pregnant Women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Individual and his / her spouse do not have confirmed psychiatric illness (self-report and electronic file of spouse and pregnant woman)
Failure to receive psychological treatment for the past six months in the individual and his or her spouse
By age 10 to 30 weeks when enrolling in the study.
Diagnosis of Violence According to the Conflict Resolution Tactics Questionnaire in Pregnant Women in Each Area of the Questionnaire
Willing to participate in the study.
Exclusion criteria:
Stressful event in the life of each couple, such as the death of a first-degree family member, or an accident that caused physical or mental injury in the past three months
Infertility and receiving pre-pregnancy infertility treatments
Consumption of drugs, tobacco and alcohol in the person and his or her spouse
Couples on the verge of separation
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
A multi-stage cluster method will be used to select the research units in this study. In the first phase, all Buin Zahra comprehensive health services centers (5 Buen Zahra comprehensive health services centers, Seqsabad, Dunesfahan, Shawl and Ardagh) will be studied after referring to comprehensive municipal health services centers and reviewing all pregnant mothers' electronic records and Their spouses are selected mothers who meet the inclusion criteria. Demographic questionnaires and CTS2 questionnaires will be completed for all eligible mothers who meet the inclusion criteria;If the number of identified individuals at risk of violence at this stage exceeds the population needed for our study, approximately 80 of these individuals will be selected using a random number table. Individuals were divided into intervention and control groups.
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 Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2019-05-08, 1398/02/18
Ethics committee reference number
IR.QUMS.REC.1398.027
Health conditions studied
1
Description of health condition studied
Violence against pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Violence against pregnant women
Timepoint
Before study, immediately and three months after study
Method of measurement
Conflict Resolution Tactics Questionnaire cts2
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: six 45-minute group counseling sessions once a week
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Boin Zahra Centers
Full name of responsible person
Masoumeh Alamshahi
Street address
Western Moallem Str
City
Boin Zahra
Province
Qazvin
Postal code
3461969863
Phone
+98 28 3422 8602
Email
am.alamshahi@gmail.com
2
Recruitment center
Name of recruitment center
Ardagh Centers
Full name of responsible person
Masoumeh Alamshahi
Street address
EMAM Str
City
Ardagh
Province
Qazvin
Postal code
3461969863
Phone
+98 28 3422 8602
Email
am.alamshahi@gmail.com
3
Recruitment center
Name of recruitment center
Shal Centers
Full name of responsible person
Masoumeh Alamshahi
Street address
Emam Str
City
Shal
Province
Qazvin
Postal code
3461969863
Phone
+98 28 3422 8602
Email
am.alamshahi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
am.alamshahi@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Masoumeh Alamshahi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.23, Shahid Davood Rahimi Ave., Bagh Dabir Street
City
Qazvin
Province
Qazvin
Postal code
4361969863
Phone
+98 28 3422 8602
Email
am.alamshahi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Masoumeh Alamshahi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.23, Shahid Davood Rahimi Ave., Bagh Dabir Street
City
Qazvin
Province
Qazvin
Postal code
4361969863
Phone
+98 28 3422 8602
Email
am.alamshahi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Masoumeh Alamshahi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.23, Shahid Davood Rahimi Ave., Bagh Dabir Street
City
Qazvin
Province
Qazvin
Postal code
4361969863
Phone
+98 28 3422 8602
Email
am.alamshahi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Study Protocol
When the data will become available and for how long
End of study
To whom data/document is available
Personnel in scientific educational institutions
Under which criteria data/document could be used
To use the results of the study as sources for evaluation and
Formulate similar next interventions
From where data/document is obtainable
Masoumeh Alamshahi.am.alamshahi@gmail.com
What processes are involved for a request to access data/document
Send email requesting data
Send the data within one month to the requestor