Determination of the comparison of group counseling in a solution-centered way with routine education on the concerns of primigravida
Design
Clinical trials with control group, parallel groups, blind, randomized, quadruple block method, in the first stage, 120 subjects, in the next stage, 54 (control and intervention)
Settings and conduct
The statistical population of this study is the pregnant women referring to Sabzevar health centers to receive prenatal care in the first and second trimesters of pregnancy.
Blind : outcomes participant and a statistical analyst will not be aware of the placement of mothers from intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Women at the gestational age of 15-45 years old, primitive gravity, having at least reading and writing skills, having no mental disorder ,Participate classes, people with scores higher than 55 points of concern for pregnancy
Exit criteria:A history of mental disease and any psychiatric medication
usage , Women with abortion history Women with infertility history ،Women with chronic diseases
Intervention groups
Intervention group: In addition to receiving routine prenatal care, consultation classes will be conducted in five 90- minute sessions for 54 women. After the fifth session, post-test will be taken.
Control group: A group of 54 people who receive only routine prenatal care and will take a post-test after 5 weeks.
Tracking will be done in both groups months after the end of the consultation sessions.
Main outcome variables
worries pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180123038485N1
Registration date:2018-03-14, 1396/12/23
Registration timing:prospective
Last update:2018-03-14, 1396/12/23
Update count:0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
RAZIEH KARRABI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4464 7170
Email address
Karabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-05, 1397/01/16
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
2018-06-22, 1397/04/01
Trial completion date
empty
Scientific title
comparison of group counseling in a solution-centered way with routine education on the concerns of primigravida
Public title
comparison of group counseling in a solution-centered way with routine education on the concerns of primigravida
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with gestational capacity and 15-45 years old
Pregnancy first
Have at least reading and writing skills
Not having mental disorder
Possibility to participate in classes
People with higher score than 55 in concern for pregnancy
Exclusion criteria:
A history of mental disease and any psychiatric medication useage
Women with abortion history
Women with infertility history
Women with chronic diseases
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
120
More than 1 sample in each individual
Number of samples in each individual:
54
54 in the intervention group and 54 in the control group
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, since the participants are studying during time, and also for the equalization of the number of people assigned to the groups, a randomized our-block method is used.
Blinding (investigator's opinion)
Double blinded
Blinding description
To blind the control group, the intervention group will be invited to participate in the classes in a different health center. in addition, statistician
will not be aware of the grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of shahroud University of Medical Sciences
Street address
Seventh Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2018-01-02, 1396/10/12
Ethics committee reference number
ir.shmu.rec.1396.137
Health conditions studied
1
Description of health condition studied
Concerned pregnant women
ICD-10 code
46.6
ICD-10 code description
Undue concern and preoccupation with stressful events
Primary outcomes
1
Description
The score obtained from the Cambridge Worry Questionnaire in pregnant women at the end of the counseling period was two months (two months after intervention).
Timepoint
The questionnaire is completed by pregnant women in the first and second trimesters of pregnancy in three stages. In the first stage, at the beginning of the study (before the intervention) and the second stage, five group counseling sessions were held in both groups and the third stage 2 months after the end of the counseling sessions A group is in both groups (admission and control)
Method of measurement
Cambridge Worry Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 5 Solution-centered counseling sessions (each session has a specific structure) with receiving routine care
Category
Prevention
2
Description
Control group: receive routine pregnancy care(All care provided by pregnant women in accordance with the Ministry of Health)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Sabzevar University of Medical Sciences
Full name of responsible person
Razieh karrabi
Street address
Sabzevar Health Center, Taleghani St., Sabzevar, Khorasan Razavi, Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613985641
Phone
+98 51 4464 5200
Email
Vc.Health@medsab.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emami
Street address
Central Building of Shahrood University of Medical Sciences, Shahruod,Haft Tir Square,Shahruod,Semnan, Iran
City
Shahroud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Razieh Karrabi
Position
Mst Student of consultation in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Central Building of Shahrud University of Medical Sciences, Shahruod,Haft Tir Square,Shahruod,Semnan, Iran
City
Shahrud,
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
karabi@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Farjamfar
Position
Academic staff of Shahrud University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Central Building of Shahrud University of Medical Sciences, Shahruod,Haft Tir Square,Shahruod,Semnan, Iran