Determining the effect of individual counseling on the spiritual health of pregnant women exposed to domestic violence
Design
A parallel clinical trial with a control group, a targeted sampling with randomization,
Settings and conduct
In this study, pregnant women aged 15- 49 years who referred to comprehensive centers of health in 4 districts in Tehran, after completing the questionnaires and selecting the subjects exposed to violence, 60 subjects were randomly assigned to two groups of intervention and control. 30 patients in the control group and 30 in the intervention group will be randomly assigned. Then, 8 individual counseling sessions will be held weekly for the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women at risk of domestic violence, aged 15-49 years, absence of known psychological illnesses (according to participants themselves), lack of underlying diseases.
Exclusion criteria: having no tendency to continue participation in counseling sessions, loss of pregnancy, failure to complete the questionnaire
Intervention groups
Intervention 1: The intervention group will have 30 people who will receive individual counseling within 8 sessions of 60-45 minutes. All consultation sessions will be held by the researcher.
Intervention 2: The control group will not receive any advice.
Main outcome variables
Spiritual welbeing; domestic violence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171025037000N2
Registration date:2019-03-02, 1397/12/11
Registration timing:retrospective
Last update:2019-03-02, 1397/12/11
Update count:0
Registration date
2019-03-02, 1397/12/11
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4409 4574
Email address
a.akhtaribami@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2018-06-22, 1397/04/01
Actual recruitment end date
2018-08-23, 1397/06/01
Trial completion date
2018-11-21, 1397/08/30
Scientific title
The effect of individual counseling on the spiritual health of pregnant women at risk of domestic violence
Public title
The effect of Spiritual Health Consultation on Domestic Violence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women exposed to domestic violence
From 15 years old to 49 years old
Absence of known psychological diseases (according to participants' self-declaration)
Lack of underlying diseases
Exclusion criteria:
having no tendency to continue participation in counseling sessions
Losing pregnancy
Failure to complete the questionnaire
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, pregnant women aged 15- 49 years who referred to comprehensive centers of health in 4 districts in Tehran, after completing the questionnaires and selecting eligible individuals, 60 subjects were randomly
assigned to two groups of intervention and control and randomly 30 in the control group and 30 in the intervention group.
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
fl. 1, Ethics Committee of Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2007-10-25, 1386/08/03
Ethics committee reference number
IR.QUMS.REC.1396.299
Health conditions studied
1
Description of health condition studied
Sexual Violence by Sex Partner
ICD-10 code
T74.2
ICD-10 code description
Sexual abuse
2
Description of health condition studied
Physical Violence by Sex Partner
ICD-10 code
R45.6
ICD-10 code description
Physical Violence
3
Description of health condition studied
Verbal-Emotional Violence by a Sex Partner
ICD-10 code
T74.31
ICD-10 code description
Emotional Violence
Primary outcomes
1
Description
Domestic violence
Timepoint
At baseline and four weeks after the intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
spiritual Health
Timepoint
At the time of admission, hold eight consultation sessions, four weeks after the end of the intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention 1: there will be 30 people in the intervention group, who will receive individual counseling during eight sessions of 60-45 minutes and all the counseling classes will be held by the researcher.
Category
Behavior
2
Description
Intervention 2: Control group؛ The control group will receive no counseling
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Preparatory Class For Delivery In The Kan Community Health Center
Full name of responsible person
Nahid Hossaini
Street address
Adhami St., Solaqan Path, Shahre Ziba St.
City
Tehran
Province
Tehran
Postal code
14886/76611
Phone
+98 21 4430 0894
Email
nahid.hosseinya@gmail.com
2
Recruitment center
Name of recruitment center
Preparatory Class For Delivery In The Yaft Abad Community Health Center
Full name of responsible person
Mahsa Fakhraie
Street address
Zafarghandi Al., Mostafa Hashem St., Zandiye St., Alqadir Sq., Yaft Abad St.
City
Tehran
Province
Tehran
Postal code
13777/17651
Phone
+98 21 6681 3076
Email
Fakhraiem92@gmail.com
3
Recruitment center
Name of recruitment center
Preparatory Class For Delivery In The Valfajr Health Center
Full name of responsible person
Arezo Rahimiyan
Street address
West Dastgheib St., Ostad Moein St., Azadi St.
City
Tehran
Province
Tehran
Postal code
13498/45951
Phone
+98 21 6602 3042
Email
arezorahimian70@gmail.com
4
Recruitment center
Name of recruitment center
Preparatory Class For Delivery In The Famanfamaeeyan Health Center
Full name of responsible person
Manijeh Naderi
Street address
Oppo. Melli Bank, Cross Roshdiye, East Azarbayejan St., South Kargar St.
City
Tehran
Province
Tehran
Postal code
13186/18311
Phone
+98 21 6659 1011
Email
mina_114@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
ِDr. Amir Peimani
Street address
Path. Mavaddat, Beheshti Boul
City
Qazvin
Province
Qazvin
Postal code
13911/34156
Phone
+98 28 3333 7006
Email
apeymani@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?