This study would be done with aime to assess the effect of group discussions on anxiety and stress of primipara pregnant women in Khorramabad . This is not blind clinical trial. The study population included primipara pregnant women (with gestational age of 20 weeks and more) referring to Poshte number 1 health center in the city of Khorramabad that 46 peoplein available sampling selected as sample and randomly would divided in two control and study groups. Both groups would be homogenous for intervention variables. Before the intervention, to assess the level of anxiety and stress Spillberger and Cohen questionnaire will be provided to both groups . Then the experimental group participantsfor 6 Session 1-1.5 hours (each week a meeting) will participate in group discussions. But in the control group the routine care of health center will be executed. After four weeks of the last session of discussion, anxiety and stress by mentioned tools in both groups Is measured.
Inclusion criteria: primipara pregnant women with gestational age 20 to 25 weeks; no known cardiovascular disease, diabetes, mental illness; lack of participation on training program on the topic over the past 20 week, no history of pregnancy and abortion; participants husband alive.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092814333N40
Registration date:2015-10-12, 1394/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-12, 1394/07/20
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2015-08-07, 1394/05/16
Expected recruitment end date
2015-11-07, 1394/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness and non-effectiveness of group discussion on anxiety and stress of primipara pregnant women in Khorramabad in2015
Public title
the effect of group discussions on anxiety and stress of primipara pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primipara pregnant women with gestational age 20 to 25 weeks; no known cardiovascular disease, diabetes, mental illness; lack of participation on training program on the topic over the past 20 week, no history of pregnancy and abortion; participants husband alive
Exclusion criteria: not wanting to continue the cooperation; the creation of any physical or mental health problem; more than twice absence in training
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by throwing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2015-06-23, 1394/04/02
Ethics committee reference number
kums.rec.1394.43
Health conditions studied
1
Description of health condition studied
Anxiety and stress in pregnancy
ICD-10 code
F41.3
ICD-10 code description
Other mixed anxiety disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Beginning of the study and 4 weeks after the study
Method of measurement
According to Spielberger Questionnaire
2
Description
Stress
Timepoint
Beginning of the study and 4 weeks after the study
Method of measurement
According to Cohen Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In experimental group participantsfor 6 Session 1-1.5 hours (each week a meeting) will participate in group discussions.
Category
Treatment - Other
2
Description
In the control group the routine care of health center will be executed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Poshte number 1 health center
Full name of responsible person
Elham Sheykh Azadi
Street address
City
Khoramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
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, Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Azam Bakhteh
Position
MSc of maternal and child health
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3828 0642
Fax
Email
Bakhteh_a@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)