The purpose of this study are to determine the effect of individual counseling on anxiety of women with unwanted pregnancy. The study was randomized clinical trials on women with unwanted pregnancy in the intervention and control groups. At least sample volume for each group of 20 people and a total are considered of 40 people. participants in research are selected between pregnant women that referred to health centers in dependent on the city of Qom that are in the first trimester of pregnancy.The inclusion criteria are: gestational age less than 14 weeks, unwanted pregnancy, absence of anxiety disorders and depression The exclusion criteria are: participants' unwillingness to continue cooperation in research,lock of participating in sessions 2 sessions or more, any pregnancy complications. In this study at first the Cattell questionnaire and demographic as the test is completed by both groups and anxiety levels measured in both groups, in the next stage intervention as individual consulting is begins for the intervention group, So that unit of the research groups in terms case are participating in consultation meetings that 3 to 4 sessions of individual counseling with intervals of 4 to 7 days. the time of sessions are 30 to 50 minutes in terms tolerance. Finally, a month after the last counseling session level of anxiety in both groups are measured and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110824943N1
Registration date:2015-12-12, 1394/09/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-12, 1394/09/21
Registrant information
Name
Leila Safdari
Name of organization / entity
School of Nursing and Midwifery, Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3826 1083
Email address
lsafdari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of individual counseling on anxiety of women with unwanted pregnancy
Public title
Effect of individual counseling on anxiety of women with unwanted pregnancy
Purpose
Health service research
Inclusion/Exclusion criteria
inclusion criteria:Including consent for the study, gestational age less than 14 weeks, unwanted pregnancy, marital status, absence of anxiety disorders and depression, lack of taking medications that increase anxiety and depression, absence of mental illness in wife and is living in the city of Qom.
Exclusion criteria: Exclusion criteria in this study included participants' unwillingness to continue cooperation in research,lock of participating in sessions 2 sessions or more, of any pregnancy complications such as symptoms of threatened abortion, fetal death and more.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study randomized was conducted using a random numbers table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd, the number 2 Building
City
kermanshah
Postal code
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
KUMS.REC.1394.156
Health conditions studied
1
Description of health condition studied
anexity
ICD-10 code
F40.8
ICD-10 code description
Other phobic anxiety disorders
Primary outcomes
1
Description
anxiety
Timepoint
Before and one month after intervention
Method of measurement
cattell
Secondary outcomes
empty
Intervention groups
1
Description
control group, at first The Cattell questionnaire was completed by patients and measured level of anxiety in people. In this group the subjects not given counseling and special training and just receiving prenatal care. Finally, a month after the last session of the counseling groups Cattell questionnaire was completed by subjects and level of anxiety is measured and compared.
Category
Other
2
Description
intervention group, at first the Cattell questionnaire in order to assess the anxiety completed with intervention group. Then participate in counseling sessions. For individual counseling are using advice steps of GATHER. unit of the research groups in terms case are participating in consultation meetings that 3 to 4 sessions of individual counseling with intervals of 4 to 7 days. the time of sessions are 30 to 50 minutes in terms tolerance. Finally, a month after the last counseling session anxiety of subjects are assessed and compared.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza (AS) Health Center
Full name of responsible person
Leila Safdari
Street address
Imam zade Ebrahim Street, Qom
City
Qom
2
Recruitment center
Name of recruitment center
Health center khorakian
Full name of responsible person
Leila Safdari
Street address
15 Khordad Street, Qom
City
Qom
3
Recruitment center
Name of recruitment center
Imam khomeini Health center
Full name of responsible person
Leila Safdari
Street address
Boniad Street
City
Qom
4
Recruitment center
Name of recruitment center
Health center baghiat alah
Full name of responsible person
Leila Safdari
Street address
Alley 17, Shahreghaem street
City
Qom
5
Recruitment center
Name of recruitment center
Healh center panbe chi
Full name of responsible person
Leila Safdari
Street address
Imam Khomeini Street
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Kermanshah University of Medical Sciences
Full name of responsible person
cyrus hamzehi
Street address
shahid beheshti Blvd, Number 2 Building
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
Name of organization / entity
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Marzieh Kaboudi
Position
Ph.D., Scientific Advisory Board
Other areas of specialty/work
Street address
Dolatabad, School of Nursing and Midwifery
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
fkaboudi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Marzieh Kaboudi
Position
Ph.D., Scientific Advisory Board
Other areas of specialty/work
Street address
Dolatabad, School of Nursing and Midwifery
City
kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
fkaboudi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Leila Safdari
Position
P.H.D
Other areas of specialty/work
Street address
Dolatabad, School of Nursing and Midwifery
City
kermanshah
Postal code
Phone
00
Fax
Email
lsafdari@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)