Objective: The aim of this randomized controlled experimental study will be determined the effectiveness of group counseling using solution-oriented approach for managing stress during pregnancy.
Design: The statistic population of study will include pregnant women of Bojnoord who will come to health centers of the city. PSS-14 questionnaire will be the tool for stress evaluation
Setting and conduct: The method of collecting samples is in a way that we will choose all the health care centers of the city. then mothers will be asked to complete two questionnaires, one is about demographic information and the other one will be perceived stress scale questionnaire. When the number of mothers with high stress will reach to 54, then we randomly divide them to two controlled and experimental groups.
Major inclusion and exclusion criteria: at least 18 years old and they mothers should be in 17 to 20 weeks of their gestational age and have no known mental illness and accruing the mark above 8 out of 21 in PSS-14 questionnaire, and they can leave the study if they experience the stressful events during the study.
Intervention: For control group regular prenatal care will be done and for experimental group will have the group counseling sessions of solution.The group counseling sessions will be 4, each one 90 minutes and in 4 following weeks will be held
Main outcome measures: Stress management
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015062022828N1
Registration date:2015-09-16, 1394/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-16, 1394/06/25
Registrant information
Name
Akram Aslani
Name of organization / entity
Shahroud Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 0428
Email address
aslani@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahroud University of Medical Sciences
Expected recruitment start date
2015-08-12, 1394/05/21
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group counseling with problem solving approach to management of prenatal stress
Public title
The effect of counseling on prenatal stress
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: minimum 18 years old, 17 to 20 weeks of gestational age, willingness to participate in the study, accruing the mark above 8 out of 21 in PSS-14 questionnaire, No formal consultation before entering the study, not having a known mental illness, no treating with tranquilizers.
Exclusion criteria: the death of one of close relatives or any stressful events that happen during the study, the need to prescribe any medication or psychotherapy counseling during the study, irregular attendance in solution-oriented group counseling.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Will be randomized by Random numbers table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahroud University of Medical Sciences
Street address
7 Tir Square headquarters of Medical Sciences university of shahroud
City
Shahroud
Postal code
3614773955
Approval date
2015-06-10, 1394/03/20
Ethics committee reference number
ir.shmu.rec.1394.51
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
Stress management
Timepoint
Before the intervention, one month after the started of the intervention and one month after the end of the intervention
Method of measurement
pss-14 Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study the intervention is via holding group counseling sessions with solution-oriented approach (4 sessions and each one 90 minutes) for experimental group.
Category
Prevention
2
Description
Control group: There is no intervention for control group and they only receive routine pregnancy care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center Shahid Kamyab
Full name of responsible person
Akram Aslani
Street address
Telephone center opposite, Settlements intersection shahed
City
Bojnoord
2
Recruitment center
Name of recruitment center
Health center Shahid Madani
Full name of responsible person
Akram Aslani
Street address
Molla sadra street, after bascool intersection, Imam Khomeini street
City
Bojnoord
3
Recruitment center
Name of recruitment center
Health center Shahid Fayyaz bakhsh
Full name of responsible person
Akram Aslani
Street address
Behzisty street
City
Bojnoord
4
Recruitment center
Name of recruitment center
Health center Olia
Full name of responsible person
Akram Aslani
Street address
Health old alley, Ferdosi street
City
Bojnoord
5
Recruitment center
Name of recruitment center
Health center Javadiyeh
Full name of responsible person
Akram Aslani
Street address
javadiyeh Square
City
Bojnoord
6
Recruitment center
Name of recruitment center
Health center Boali
Full name of responsible person
Akram Aslani
Street address
Yas alley, Between ghiam and kargar square
City
Bojnoord
7
Recruitment center
Name of recruitment center
Health center Horr
Full name of responsible person
Akram Aslani
Street address
Horr street
City
Bojnoord
8
Recruitment center
Name of recruitment center
Health center Mehre salamat
Full name of responsible person
Akram Aslani
Street address
Golestanshahr
City
Bojnoord
9
Recruitment center
Name of recruitment center
Health center Taleghani
Full name of responsible person
Akram Aslani
Street address
Nomber 103, Mehr 10, Mehr street, Bazargani square
City
Bojnoord
10
Recruitment center
Name of recruitment center
Health center Sharghe Sepah
Full name of responsible person
Akram Aslani
Street address
Sharghe Sepah
City
Bojnoord
11
Recruitment center
Name of recruitment center
Health center Farhangian
Full name of responsible person
Akram Aslani
Street address
Farhangian Settlements
City
Bojnoord
12
Recruitment center
Name of recruitment center
Health center Mahoor
Full name of responsible person
Akram Aslani
Street address
Mahoor Alleyو Boulevard Moallem
City
Bojnoord
13
Recruitment center
Name of recruitment center
Health center Shahre bazi
Full name of responsible person
Akram Aslani
Street address
17 Shahrivar square
City
Bojnoord
14
Recruitment center
Name of recruitment center
Health center Bagherkhan
Full name of responsible person
Akram Aslani
Street address
Next Yenge ghaleah park
City
Bojnoord
15
Recruitment center
Name of recruitment center
Health center Malkesh
Full name of responsible person
Akram Aslani
Street address
Malkesh
City
Bojnoord
16
Recruitment center
Name of recruitment center
Health center Imam Hossein
Full name of responsible person
Akram Aslani
Street address
Shahede 13, Intersection shahed
City
Bojnoord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hasan Emamian
Street address
7 Tir Square, headquartersshahroud University of Medical Sciences
City
Shahroud
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, Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Akram Aslani
Position
Master of science student
Other areas of specialty/work
Street address
7 Tir Square quarters Head Shahroud Univercity of Medical Sciences