This study is done to evaluate the effectiveness of individual psycho-educational counseling on the level of anxiety among pregnant women suffering from preeclampsia. the sample group consist of 44 patients who are randomly divided equally into two intervention and control group(the member of each group=22).the members of intervention group, After admission and before any usual medical treatment, 2 psycho-educational counseling sessions are held for 45 minutes and 24 hours apart and Pregnant women with preeclampsia diagnosis and low to moderate anxiety score can participate in this study and Women who do not attend counseling sessions or have complications of pregnancy can’t participate in this study . Primary outcome: it is expected that psycho-educational counseling be effective the level of anxiety among hospitalized women suffering from preeclampsia
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082029817N3
Registration date:2017-09-04, 1396/06/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-04, 1396/06/13
Registrant information
Name
Esmat Nuhi
Name of organization / entity
Kerman University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5220
Email address
e_nuhi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Kerman University of Medical Sciences
Expected recruitment start date
2017-01-30, 1395/11/11
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of individual psycho-educational counseling on the level of anxiety among pregnant women suffering from preeclampsia
Public title
Effectiveness of individual psycho-educational counseling on the level of anxiety among pregnant women suffering from Pregnancy poisoning
Purpose
Supportive
Inclusion/Exclusion criteria
indusion criteria: Pregnant women with preeclampsia diagnosis, gestational age 20 weeks and up, low risk pregnancy, ability to understand and speak Persian, low to moderate anxiety score based of the Spielberger State–Trait Anxiety Inventory.
Exclusion criteria: Incidence of pregnancy complications, incidence Mental injuries during the intervention period, absence from training sessions, history of specific mental illness
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
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
Kerman University of Medical Sciences Ethics Committee
Street address
Campus University beginning around seven gardens Alavi;Kerman
City
Kerman
Postal code
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.KMU.REC.1395.556
Health conditions studied
1
Description of health condition studied
preeclampsis
ICD-10 code
O10-O16
ICD-10 code description
Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
anxiety
Timepoint
before intervention and half an hour after the intervention
Method of measurement
Spielberger State–Trait Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, two psycho-educational counseling sessions are held for 45 minutes and 24 hours apart
Category
Behavior
2
Description
The control group,only routine procedures done
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Gharazi-Sirjan hospital
Full name of responsible person
Tayebe Abazarnejad
Street address
Sirjan, Malek Ashtar Blvd., Shafa St.
City
Sirjan
2
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Tayebe Abazarnejad
Street address
Sirjan, Ebne sina Street
City
Sirjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Kerman University of Medical Sciences
Full name of responsible person
Dr.Abbas Pardakhty
Street address
Campus University of Medical Sciencesbeginning around seven gardens Alavi;Kerman
City
Kerman
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 Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Tayebe Abazarnejad
Position
Master of Midwifery Consultation
Other areas of specialty/work
Street address
Campus Universityof Medical Sciences beginning around seven gardens Alavi;Kerman
City
Kerman
Postal code
Phone
+34 331325220
Fax
Email
t.abazarnejad@gmail.com
Web page address
www.kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Doctor Esmat.Nouhi
Position
PhD
Other areas of specialty/work
Street address
Campus University of Medical Sciences beginning around seven gardens Alavi;Kerman
City
Kerman
Postal code
Phone
+98 34331325220
Fax
Email
e_nuhi@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Tayebe Abazarnejad
Position
Master of Midwifery Consultation
Other areas of specialty/work
Street address
Campus University of Medical Sciences beginning around seven gardens Alavi;Kerman
City
Kerman
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)