This research was a clinical trial study that was designed to examine the effect of group counseling on pregnant women’ anxiety in Sheibani Health service. Inclusion criteria : 18-35 years age; first pregnancy; 8-18 weeks gestational age based on last menstrual Period; lack of mental diseases or anxiety induced diseases such as hyperthyroidism; lack of sever and pathologic anxiety based on Speigel Berger anxiety questionnaire.
Exclusion criteria : gaining 10 or more score in Beck depression scale; presence in pregnancy period preparation classes out of designed program and absence in consultation classes more than 1 session. The study population consisted of all pregnant women were referred to Sheibani Health Centeri.
Study population were 90 pregnant women. They were allocated into two experimental and control groups. Experimental group received group consultation and routine pregnancy period cares but control group received only routine cares. Group consultation sessions were designed for 5 sessions during 5 weeks that each session lasted 60 to 90 minutes. Evaluation at the end of the fifth week intervention was conducted by Spielberger Anxiety Questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111214529N2
Registration date:2012-02-27, 1390/12/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-27, 1390/12/08
Registrant information
Name
Nourossadat Kariman
Name of organization / entity
Shaheed Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 3133
Email address
n_kariman@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing and Midwifery College of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2010-12-30, 1389/10/09
Expected recruitment end date
2011-07-03, 1390/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of group counseling on pregnancy anxiety
Public title
Effectiveness of group counseling on pregnancy anxiety
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria : 18-35 years age; first pregnancy; 8-18 weeks gestational age based on last menstrual Period; lack of mental diseases or anxiety induced diseases such as hyperthyroidism; lack of sever and pathologic anxiety based on Speigel Berger anxiety questionnaire.
Exclusion criteria : gaining 10 or more score in Beck depression scale; presence in pregnancy period preparation classes out of designed program and absence in consultation classes more than 1 session.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Shahid Beheshti Medical University, Den of research
Street address
Shahid Beheshti Medical University, Evin, Tehran
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
116/3043
Health conditions studied
1
Description of health condition studied
Anxiety in Pregnancy
ICD-10 code
F40-F48
ICD-10 code description
Neurotic, stress-related and somutoform disorders
Primary outcomes
1
Description
Anxiety
Timepoint
5 Weeks
Method of measurement
Speigel Berger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Group counseling / Control: Routine pregnancy care
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheibani Health Center
Full name of responsible person
Marjaneh Dayhimi
Street address
Sheibani Health Center, Hafez Alley, Between Qanat and Dibaj, Kolahdooz street, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti Medical University
Full name of responsible person
DR. Ghanati K
Street address
International Branch Shahid Beheshti University of Medical Sciences, Tavanir street, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Medical University
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
Nursing and Midwifery College of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marjaneh Dayhimi
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery College of Shahid Beheshti University of Medical Sciences, Niayesh, Vali Asr street, Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
marjan_day@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery College of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nourossadat Kariman
Position
MS in Midwifery, Faculty Members of Shahid Beheshti Medical University
Other areas of specialty/work
Street address
Nursing and Midwifery College of Shahid Beheshti University of Medical Sciences, Niayesh, Vali Asr street, Tehran
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
n_kariman@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Marjaneh Dayhimi
Position
MSC in Midwifery, International Branch of Shahid Beheshti Medical University
Other areas of specialty/work
Street address
Nursing and Midwifery College of Shahid Beheshti University of Medical Sciences, Niayesh, Vali Asr street, Tehran
City
Tehran
Postal code
Phone
Fax
Email
marjan_day@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)