As the research setting, two preparatory class for delivery and six health centers (from tree groups in Zanjan will be randomly selected based on social and economic situations). At first, the conflict tactics scale questionnaire will be given to the pregnant mothers qualified for the study. After analyzing the questionnaire, pregnant woman who exposed to domestic violence and having the tendency to participate will be recruited. Convenience sampling with blocked random allocation will be done. The participants will be allocated in to the intervention group and control group with 45 people each. The intervention group will have 6 sessions of 90 minutes individual based counselling and the control group will have no kind of counselling. Counselling sessions will be done in the preparatory classes for the childbirth in the health centers. In order to achieve higher efficacy, all participants will receive positive key messages at the end of each session. At the end of each two counselling sessions, main points of each session will be presented. Six weeks after the last session, the questionnaire will be completed in both the intervention and control groups by trained interviewers who are unaware of the group assignment for the single blinding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040628352N4
Registration date:2017-08-20, 1396/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Roghieh Kharaghani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8144
Email address
r.kharaghani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Chancellor for Research and Technology of Zanjan University of Medical Sciences
Expected recruitment start date
2017-08-07, 1396/05/16
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of solution focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence
Public title
The effect of solution focused counseling on violence rate and quality of life of pregnant women at risk of domestic violence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria; The existence of any kind of mild or average Physical, psychological, or sexual violence either in mothers based on CTS 2 questionnaire; mothers over 18 years of age; the gestational age of 27 weeks or less based on LMP or sonography; the ability of reading and writing; living in Zanjan; having the minimum of one year married life with her husbands; not participating in other classes and counselling courses at the same time; having a cell phone; lack of underlying diseases; lack of the known psychological disease; not using psychological drugs; no substance abuse in women and their husbands; not having the stressful events in the past year either for her or their husbands; not having any pregnancy side effects such as preeclampsia or vaginal bleeding or etc; tendency in regular participation in counselling sessions; married life with her husbands during the study period. Exclusion criteria; having no tendency to continue participation in counselling sessions and absence of one session; Occurrence of any pregnancy side effects such as Preeclampsia or etc.
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A randomized blocked design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Ethics committee of Zanjan University of Medical Sciences, First floor, North side Azadi, Zanjan
City
Zanjan
Postal code
Approval date
2017-06-04, 1396/03/14
Ethics committee reference number
ZUMS.REC.1396.37
Health conditions studied
1
Description of health condition studied
Sexual violence by an intimate partner
ICD-10 code
T74.2
ICD-10 code description
Sexual abuse
2
Description of health condition studied
Psychological violence by an intimate partner
ICD-10 code
T74.3
ICD-10 code description
Psychological abuse
3
Description of health condition studied
Physical violence by an intimate partner
ICD-10 code
R45.6
ICD-10 code description
Physical violence
Primary outcomes
1
Description
Domestic violence
Timepoint
At baseline and sex weeks after the intervention
Method of measurement
Conflict tactics scales 2
Secondary outcomes
1
Description
Quality of life
Timepoint
At baseline and sex weeks after the intervention
Method of measurement
Short form health survey
Intervention groups
1
Description
Intervention 1: there will be 45 people in the intervention group, who will receive individual solution focused counselling during six sessions of 90 minutes and all the counselling classes will be held by the researcher. In order to achieve higher efficacy, all participants will receive positive key messages at the end of each session. At the end of each two counselling session, main points of each session will be presented
Category
Behavior
2
Description
Intervention 2: The control group will receive no counselling
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Preparatory Class For Delivery In The Health Centers Number 3
Full name of responsible person
Street address
Health center number 3, Saadi Crossroad, Zanjan
City
Zanjan
2
Recruitment center
Name of recruitment center
Preparatory Class For Delivery In The Ayatollah Mousavi Hospital
Full name of responsible person
Street address
Ayatollah Mousavi Hospital, Road Gavazang, Zanjan
City
Zanjan
3
Recruitment center
Name of recruitment center
Health Center Number 1
Full name of responsible person
Street address
Next to city health center, Amirkabir Crossroad, Zanjan
City
Zanjan
4
Recruitment center
Name of recruitment center
Health Center Number 6
Full name of responsible person
Street address
Shaheed Hassani Street, Islamabad, Zanjan
City
Zanjan
5
Recruitment center
Name of recruitment center
Health Center Number 9
Full name of responsible person
Street address
Fateh Street, Honarestan Square, Zanjan
City
Zanjan
6
Recruitment center
Name of recruitment center
Health Center Number 12
Full name of responsible person
Street address
First Crossroad, Koochemeshki Street, Zanjan
City
Zanjan
7
Recruitment center
Name of recruitment center
Health Center Number 13
Full name of responsible person
Street address
Next to committee Emdad, Khayyam Street, Zanjan
City
Zanjan
8
Recruitment center
Name of recruitment center
Health Center Number 18
Full name of responsible person
Street address
Shayesteh Street, Phase 4, Golshahr, Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor for Research and Technology of Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
North side Azadi Boulevard
City
Zanjan
Grant name
پایان نامه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor for Research and Technology of Zanjan 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
Zanjan University of Medical Science
Full name of responsible person
Sepideh Dinmohammadi
Position
Msc student of midwifery counselling
Other areas of specialty/work
Street address
N 942, Phase 2, Karmandan town, Zanjan
City
Zanjan
Postal code
33148319
Phone
+98 24 3344 5026
Fax
+98 24 3314 8319
Email
sepideh.dinmohammadi@ yahoo.com
Web page address
www.zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Zanjan University of Medical Sciences, Mahdavi Blvd, Zanjan
City
Zanjan
Postal code
33148319
Phone
+98 24 3315 6344
Fax
+98 24 3314 8319
Email
r.kharaghani@zums.ac.ir
Web page address
www.zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Karmandan town, Zanjan
City
Zanjan
Postal code
Phone
+98 24 3315 6344
Fax
Email
r.kharaghani@zums.ac.ir
Web page address
www.zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)