1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
The effect of educational program on domestic violence and quality of life in early married couples
Protocol summary
Summary
The purpose of the study: To investigate the effect of educational program on domestic violence and quality of life of the couples with early marriage. Design of the study: Randomized controlled trial with random allocation of individuals to intervention and control without blinding. The couples who enter the study will be randomly allocated into two groups of training
intervention and control using the random allocation software and stratified blocking based on the presence and absence of a child with four and six block sizes with a 1: 1 ratio. Study population: Adolescent women aged between 11-19 years old and their couples. Inclusion criteria: The age of woman between 11 and 19 years; the occurrence of one aspect of domestic violence by the CTS2 questionnaire in the women; the first marriage of couples. Exclusion criteria: Having mental illness and its history in woman and taking psychotropic drugs;
occurrence of stressful life events in the last year in woman; addiction or habitual consumption of addictive substances in men and women. Sample size: Total 106 couples. The training program will be implemented in three sessions. The content of the training sessions will be prepared and compiled from three sources: 1) Information in scientific texts 2) The needs assessment of adolescent married women 3) Individual interviews with experts and professors in the field of psychology.
Time of intervention: One and a half hours per week (three consecutive weeks). Primary outcomes: rate of domestic violence and quality of life one and two month after training.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2017070334052N2 Registration date: 2017-08-11, 1396/05/20 Registration timing: registered_while_recruiting
Last update:
Update count: 0 Registration date
2017-08-11, 1396/05/20 Registrant information
Name
Niloofar Sattarzadeh
Name of organization / entity Tabriz University of Medical Sciences Country
Iran (Islamic Republic of) Phone
+98 41 3477 2699 Email address
sattarzadehn@tbzmed.ac.ir Recruitment status
Recruitment complete Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date 2017-07-23, 1396/05/01
Expected recruitment end date 2017-10-22, 1396/07/30 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
The effect of educational program on domestic violence and quality of life in early married couples
Public title
The Impact of Education on Domestic Violence in adolescent Couples
Purpose
2 Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The official marriage; Wife's age between 11-19; the first marriage of women; The first marriage of men; Having reading and writing literacy(in women); Having health records in urban health
complexes(in women); The occurrence of one of the dimensions of domestic violence according to the CTS2 questionnaire in the person under study(in women);
having Physical and mental health according to the person and health records(in women); Exclusion criteria:
Having mental illness and having its history in woman and taking psychedelic drugs; occurrence of stressful life events such as the death of loved ones in the last year in woman; addiction or habitual consumption of addictive substances in men and women.
Age
From 11 years old to 19 years old Gender
Both Phase
N/A
Groups that have been masked No information
Sample size
Target sample size: 106
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 Tabriz University of Medical Sciences.
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue
City Tabriz Postal code
00984133357310 Approval date
2017-06-21, 1396/03/31
Ethics committee reference number IR.TBZMED.REC.1396.233
Health conditions studied
1
Description of health condition studied Domestic violence
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Domestic violence Timepoint
Before training, 4 and 8 weeks after ending training Method of measurement
CTS2 questionnaire
2
Description Quality of Life Timepoint
Before training, 4 and 8 weeks after the end of training Method of measurement
Whoqol questionnaire
Secondary outcomes
1
Description Depression Timepoint
Before training, 4 and 8 weeks after the end of training Method of measurement
Beck Questionnaire 2
Intervention groups
1
Description
For the intervention group, the training program will be held in three sessions (one hour per every training session and one half hour for questions and answers) for three consecutive weeks through lecture and using the available scientific resources and opinion of the
professors of the psychologist. Participants will receive a training package and pamphlet.
Category Prevention
2
Description
The control group will receive no intervention at the time of the study (If the training be effective for the
intervention group, a training session will also be held for the control group after completing the study).
3 Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Integrated Urban Health Care Center 1 Full name of responsible person
Tayyebeh Hatamian-Maleki Street address
Opposite to the central laboratory, Imam Khomeini Street
City Malekan
2
Recruitment center
Name of recruitment center
Integrated Urban Health Care Center 2 Full name of responsible person
Tayyebeh Hatamian-Maleki Street address
Abbasi Alley,Teacher Street City
Malekan
3
Recruitment center
Name of recruitment center
Integrated Urban Health Care Center 3 Full name of responsible person
Tayyebeh Hatamian-Maleki Street address
Next to the mosque, Phase One, Valiasr Town City
Malekan
Sponsors / Funding sources
1 Sponsor
Name of organization / entity
Vice-Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person Dr. Mohammad Reza Rashidi Street address
Research department, 3rd floor, Central building number 2, Tabriz University of Medical Science , Golgasht St. azadi Avenue.
City Tabriz 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 of Tabriz 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
Fafculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person Tayyebeh Hatamian-Maleki Position
MSc Student of Midwifery Other areas of specialty/work Street address
Faculty of Nursing & Midwifery, South Shariati street City
Tabriz Postal code
5451796499 Phone
+98 41 3784 1249 Fax
+98 41 3784 1245 Email
thatamian@yahoo.com; tayebe.hatamian@gmial.com Web page address
http://nursing.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fafculty of Nursing & Midwifery, Tabriz University of Medical Sciences
Full name of responsible person Dr. Niloofar Sattarzadeh-Jahdi Position
Assistant Professor, PhD in Reproductive Health Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Southern Shariati Street
City Tabriz Postal code
5451796499 Phone
4 +98 41 4422 1874
Fax Email
sattarzadehn@tbzmed.ac.ir Web page address
http://nursing.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences
Full name of responsible person Tayyebeh Hatamian-Maleky Position
MSc Student of Midwifery Other areas of specialty/work Street address
Faculty of Nursing and Midwifery, Shariati St. South City
Tabriz Postal code
5451796499 Phone
+98 41 3784 1249 Fax
+98 41 3784 1245 Email
thatamian@yahoo.com Web page address
http://nursing.tbzmed.ac.ir
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
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