In this clinical trial, the effect of counseling interfere on anxiety in two groups of intervention and control in pregnant women candidate for amniocentesis of Urmia Motahari Hospital to come in 2015 - 2016 will be measured. In fact, perinatal midwife,reduces the anxiety of pregnant women by givind advice and ansewring their questions. This study consists of 120 patients (60 cases and 60 controls) is determined. The study population was pregnant women who were in their 20th week of pregnancy and candidating for aminocentesis. Inclusion criteria included not applying certain psychotropic medications,without having any psychotropic record in past, no history of mental disorder or hospitalization in a psychiatric hospital, and a gestational age of 20 weeks (second trimester) . Exclusion criteria included people who who are not having necessary cooperation in completing questionnaire.In this experimental study, women undergoing amniocentesis and gestational of 20 weeks of pregnancy,devided in two groups of intervention and control and will fill in the Perceived Stress Scale and State– Trait Anxiety questionnaire and researcher made one, containing the personal and pregnancy information.The intervention group receive the necessary date in one and half hour taking sitting and finaly both groups will get the educational brochure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041227347N1
Registration date:2016-06-11, 1395/03/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-11, 1395/03/22
Registrant information
Name
Nayaft Karimi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4964
Email address
karimi.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Reasercher
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of counseling based intervention on anxiety in women undergoing amniocentesis admitted to Motahari hospital in Urmia in 2015-2016
Public title
The effect on anxiety in women undergoing amniocentesis advice
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria will include: consent for inclusion؛ not applying certain psychotropic medications؛ psychotherapy having had a past؛ no history of mental disorder and hospitalized in a psychiatric hospital؛ the literate and the gestational age to 20 weeks (second trimester) will be. Exclusion criteria included people who fill in the questionnaire؛ did not have the necessary cooperation.
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Urjhans Street , Resalat Bivd , Urmia , Iran
City
Urmia
Postal code
571478334
Approval date
2015-11-30, 1394/09/09
Ethics committee reference number
ir.umsu.rec.1394.3.1
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety in women undergoing amniocentesis
Timepoint
Before and immediately after intervention
Method of measurement
Cohen Perceived Stress Scale and State – Trait Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
The demographic and fertility of the mother and the Spielberger State Anxiety Inventory and Cohen Perceived Stress Questionnaire to be completed in both the intervention and control groups. Mothers in the intervention group undergoing amniocentesis to measure anxiety levels before and after the counseling advice (before amniocentesis) Cohen Perceived Stress Scale and Spielberger State Anxiety Inventory will be completed.Videos how to perform amniocentesis for 15 minutes and for 30 minutes Bardarbh advice about women's concerns.paid for 15 minutes.
Category
Behavior
2
Description
In the control group without consultation questionnaire is completed and evaluated. And finally to the control group offering educational brochure
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Prinatalogy Center, Kowsar
Full name of responsible person
Nayaft Karimi
Street address
Street Kashani ؛ Motahari Hospital ؛ Urmia ؛ Iran
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Nayaft Karimi (Reasercher)
Street address
Urmia University of Medical Sciences ؛ Nursing and Midwifery Faculty Urmia
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
Nayaft Karimi
Position
Master Student of Midwifery Counseling
Other areas of specialty/work
Street address
Urmia University of Medical Sciences ؛ Nursing and Midwifery Faculty Urmia
City
Urmia
Postal code
Phone
+98 44 3275 4962
Fax
Email
nayaft.karimi2016@gmail.comkarimi.n@umsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Soheila Rabii Poor
Position
Phd in Reproductive Health , Science Committe Member of Nursing & Midwifery Faculty , Urmia Universi
Other areas of specialty/work
Street address
Urmia University of Medical Sciences - Nursing and Midwifery Faculty Urmia
City
Urmia
Postal code
Phone
+98 44 3275 4962
Fax
Email
soheila80@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Nayaft Karimi
Position
Master Student of Midwifery Counseling
Other areas of specialty/work
Street address
Urmia University of Medical Sciences ؛ Nursing and Midwifery Faculty Urmia
City
Urmia
Postal code
Phone
+98 44 3275 4962
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)