Determining the effect of cognitive- behavioral education on pregnant women's anxiety with positive result of Screening for abnormalities
Design
Randomized clinical trial
Settings and conduct
Counseling room in the perinatal clinic of Shahid Akbarabadi hospital which will be provided to the researcher in coordination with the hospital. . The researcher provides the welfare and health conditions and facilities (disinfection equipment and the appropriate distance between the researcher and the client and that the training classes are held individually).
Participants/Inclusion and exclusion criteria
Inclusion criteria
- Being Iranian
- Being the Persian language
- gestational age 11-15 weeks
- Primiparous women
- Single pregnancy
- State anxiety score between 31 to 75 and trait anxiety score between 31 to 72
- Have at least primary school
- Full alertness and acceptable listening and speaking ability to receive education and answer questions
Exclusion criteria
- The history of infertility
- History of serious psychiatric disorders including psychotic, bipolar and depression
Intervention groups
In the experimental group, 4 sessions of individual counseling are held for 90 minutes, two sessions a week. The first session includes explanations about the importance, features, benefits, risks and differences between screening tests in the first and second trimesters and relaxation. The second session includes misconceptions about the cause of screening anxiety, as well as A-B-C chain training. The third session includes training the presence of mind and strengthening the positive thoughts of the mother. The fourth session is a program of spontaneous change of thinking and behavior, cognitive errors.
In the control group, participants will receive routine pregnancy care. Anxiety questionnaire will be completed before and at the end of the intervention.
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180427039436N7
Registration date:2020-08-24, 1399/06/03
Registration timing:prospective
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Leila Amiri Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1139
Email address
l.amirifarahani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive- behavioral education on pregnant women’s anxiety with positive results of screening for chromosomal abnormalities
Public title
The effect of cognitive- behavioral education on pregnant women’s anxiety with positive results of screening for chromosomal abnormalities
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
Being Persian language
gestational age 11-15 weeks
Primiparous women
Single pregnancy
State anxiety score between 31 to 75 and trait anxiety score between 31 to 72
Have at least primary school
Full alertness and acceptable listening and speaking ability to receive education and answer questions
Exclusion criteria:
History of infertility
History of serious psychiatric disorders including psychotic, bipolar and depression
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
In the current study, a quadratic block randomization method will be used by the randomization.com site.
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 Committee of Iran University of Medical Sciences
Street address
Rashid yasemi
City
Tehran
Province
Tehran
Postal code
1996713883
Approval date
2020-08-18, 1399/05/28
Ethics committee reference number
IR.IUMS.REC.1399.433
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
According to Kaylan and Zadok, anxiety is a diffuse, very unpleasant feeling, often accompanied by vague anxiety that is accompanied by one or more physical feelings; Symptoms such as chest tightness, palpitations, sweating, headaches, sudden urge to urinate, restlessness, and a desire to move are also common symptoms.
Timepoint
Before the intervention and after the end of the intervention.
Method of measurement
Spielberger state-trait anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental group, 4 sessions of individual counseling are held for 90 minutes, two sessions a week. The first session includes introduction and expression of clients' feelings about the screening result and educational content including explanations about the importance, features, benefits, risks and differences between screening tests in the first and second trimesters and relaxation and homework training. The second session includes a review of the previous session's assignments and misconceptions about the cause of screening anxiety, as well as A-B-C chain training and homework. The third session includes reviewing the assignments of the previous session and training the presence of mind and strengthening the positive thoughts of the mother and homework.
Category
Behavior
2
Description
Control group: In the control group, people will receive routine pregnancy care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Abadi Hospital
Full name of responsible person
Arezoo Bayat
Street address
Molavi Street, not far from Molavi Crossroads, Ferdows Garden Station
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Fax
+98 21 5560 8012
Email
Akbarabadihosp@yahoo.com
Web page address
Http://www.crta.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Shahid Hemmat highway, District 2
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9024
Fax
+98 21 8805 2248
Email
Motevalian.a@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Fax
+98 21 4365 1138
Email
l.amirifarahani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Fax
+98 21 4365 1138
Email
l.amirifarahani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amiri Farahani
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Rashid Yasemi
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1139
Fax
+98 21 4365 1138
Email
l.amirifarahani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
it is not available
When the data will become available and for how long
it is not available
To whom data/document is available
it is not available
Under which criteria data/document could be used
it is not available
From where data/document is obtainable
it is not available
What processes are involved for a request to access data/document