Purpose of the study: The effect of family support based counselling on postnatal perceived stress
Study design: Random
Main inclusion criteria: Iranian nationality, Age between 20-35 , Nulliparous women
Main exclusion criteria: Anomaly detection, Preterm delivery, Mental illnesses, Absence of more than two meeting
Target sample size: 330
Intervention: 4-6 counseling meeting individual and group for delivery women and their families
Time intervention: Two counseling meeting 45-60 a week
Primary outcome: Reduce perceived stress
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031720778N18
Registration date:2017-04-19, 1396/01/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-19, 1396/01/30
Registrant information
Name
Fatemeh Moghaddam Tabrizi
Name of organization / entity
Uromia University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4964
Email address
moghaddam.f@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences
Expected recruitment start date
2017-04-05, 1396/01/16
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Family Support Based Counselling on Postnatal Perceived Stress in Nulliparous Women Reffered to Health Centers
Public title
The Effect of Family Support Based Counselling on Postnatal Perceived Stress
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Iranian nationality, Age between 20-35, Nulliparous women
Exclusion criteria: Anomaly detection, Preterm delivery, Mental illnesses, Absence of more than two meeting
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
330
Randomization (investigator's opinion)
Randomized
Randomization description
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
Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Postal code
Approval date
2016-11-10, 1395/08/20
Ethics committee reference number
IR.umsu.rec.1394.283
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
F43.1
ICD-10 code description
Arises as a delayed or protracted response to a stressful event or situation (of either brief or long duration) of an exceptionally threatening or catastrophic nature, which is likely to cause pervasive distress in almost anyone. Predisposing factors, suc
Primary outcomes
1
Description
Perceived Stress
Timepoint
After Intervention
Method of measurement
Post natal Perceived Stress
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 4-6 sessions of individual and group counseling for 45-60 minute, twice a week
Category
Prevention
2
Description
control group :The control group do not receive any intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Centers of Urmia University of Medical Sciences
Full name of responsible person
Fatemeh Moghaddam Tabrizi
Street address
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Fateme Mogaddam Tabrizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Postal code
Phone
+98 44 3223 4897
Fax
Email
fmtabtizi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Fateme Mogaddam Tabrizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Postal code
Phone
+98 44 3223 4897
Fax
Email
fmtabtizi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Fateme MogaddamTabrizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)