The effect of cognitive-behavioral group counseling on the anxiety of pregnant women with a history of spontaneous abortion
Design
This study is an applied research in the form of randomized trial. The present study will comprise pregnant women referred to health centers in Arak where the previous pregnancy results in abortions and the history of a live child. . The sample size is 64 people. Among 64 who were selected according to the entry criteria and the available conditions, the samples were randomly divided into two groups of 32 control and intervention groups.
Settings and conduct
The population of this study is pregnant women who are referred to health centers in Arak, where the previous pregnancy leads to abortion and the history of a child who is not living. Therefore, considering the criteria for entry and the available conditions, the samples are divided into random blocks of control and intervention. In this study, the effect of cognitive-behavioral group counseling on pregnant women with a history of abortion is conducted for intervention group. . A total of 6 60-minute sessions will be held for the intervention group. Since the standard number of participants in the consultation is 15 people. To access the minimum required sample, the intervention group will be divided into 16 categories and will be given to both groups of counseling. The sessions for the intervention group are 1 session per week and for 6 consecutive weeks. To collect information, a standard questionnaire for determining the level of anxiety Spielberg will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- The age range is 18-40 years
- Single-crowned pregnancy with a maximum gestational age of 12 weeks
- The company's ability to arrange training classes
- Do not take medications related to psychiatric disorders
- No history of drug use or smoking
- Lack of infertility history
- Anxiety disorder since 3 months ago
Exit criteria:
- Unwillingness to continue cooperation
- The occurrence of any pregnancy complications during the study (pain, abnormal heartbeat pattern, blood pressure, bleeding, etc.)
- Any pregnancy problem that requires medical intervention
- Not attending meetings: More than one abstention will be excluded
Intervention groups
The population of this study is pregnant women who are referred to health centers in Arak, where the previous pregnancy leads to abortion and the history of a child who is not living.
Main outcome variables
Level of anxiety before and after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180123038482N1
Registration date:2018-02-09, 1396/11/20
Registration timing:prospective
Last update:2018-02-09, 1396/11/20
Update count:0
Registration date
2018-02-09, 1396/11/20
Registrant information
Name
Hoda Zaraj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
h.zaraj@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral group counseling on the anxiety of pregnant women with a history of spontaneous abortion
Public title
The effect of group counseling on the anxiety of pregnant women with spontaneous abortion history
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
- The age range is 18-40 years
- Single-crowned pregnancy with a maximum gestational age of 12 weeks
- The company's ability to arrange training classes
- Do not take medications related to psychiatric disorders
- No history of drug use or smoking
Lack of infertility history
- Anxiety disorder since 3 months ago
Exclusion criteria:
- Unwillingness to continue cooperation
- The occurrence of any pregnancy complications during the study (pain, abnormal heartbeat pattern, blood pressure, bleeding, etc.)
Any pregnancy problem that requires medical intervention
- Not attending meetings: More than one abstention will be excluded
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were randomly divided into two intervention and control groups of 32 groups in each group.
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
Ethics comittee of Arak University of Medical Sciences
Intervention group: The aim of this study was to investigate the effect of cognitive-behavioral group counseling on pregnant women with a history of abortion in an intervention group. A total of 6 60-minute sessions will be held for the intervention group. How to hold sessions for the intervention group 1 session per week and 6 consecutive weeks.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Health Centers
Full name of responsible person
Hoda Zaraj
Street address
Nursing and midwifery collage, Arak University of Medical Sciences, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
h.zaraj@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Mohammad Arjomandzadegan
Street address
Arak University of Medical Sciences, Payambar Azam complex, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hoda Zaraj
Position
MSc Student in consultion midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and Midwifery Faculty, Arak University of Medical Sciences, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
h.zaraj@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Kattayon Vakilian
Position
PhD in reproductive Health and faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nursing and midwifery collage, Arak University of Medical Sciences, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
dr.kvakilian@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hoda Zaraj
Position
Msc student in consultation midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Nursing and midwifery Faculty, Arak University of Medical Sciences, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Fax
+98 86 3417 3524
Email
hoda.zaraj@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Publishing Article
When the data will become available and for how long
After one year of dissertation defence
To whom data/document is available
All people
Under which criteria data/document could be used
Information
From where data/document is obtainable
Journals
What processes are involved for a request to access data/document