Investigating of the effect of educational-psychological intervention on anxiety and worry of pregnant women in the process of fetal screening tests: randomized clinical trial with control group.
Comparison of anxiety, worry, informed choice and decision conflict of pregnant women participating in the control and two intervention groups before and 8-10 weeks after the intervention
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, on 159 people. The rand function of the Excel software was used for randomization.
Settings and conduct
The study field will be prenatal clinics of hospitals affiliated to Tehran University of Medical Sciences. Sampling will be done in an accessible and continuous manner. After obtaining written consent, they will enter the study consciously. The samples will then be divided into intervention and control groups by the Permuted-Blok Randomization method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being Muslim and Iranian; Pregnancy age less than 11 weeks;
Finishing at least fifth elementary school level, access and the possibility of using cyberspace.
Non-inclusion criteria: previous history of screening or diagnostic tests for fetal chromosomal abnormalities; employment of research units in health centers; History of mental disorders or use of psychiatric drugs; A history of having a fetus or child with Down syndrome or anomaly
Intervention groups
Intervention group 1: Group training counseling is through cyberspace.
Intervention group 2: the intervention is designed as a group educational-psychological consultation.
control group: will not receive any intervention from the research team during the study.
Main outcome variables
Anxiety and Worry
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200518047500N1
Registration date:2020-06-21, 1399/04/01
Registration timing:registered_while_recruiting
Last update:2020-06-21, 1399/04/01
Update count:0
Registration date
2020-06-21, 1399/04/01
Registrant information
Name
Zohreh Khakbazan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4220
Email address
khakbaza@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating of the effect of educational-psychological intervention on anxiety and worry of pregnant women in the process of fetal screening tests: randomized clinical trial with control group.
Public title
Investigating the Impact of Intervention on Pregnant Women's Concerning About Screening Tests
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being a Muslim and an Iranian
pregnant women with <11-week pregnancy age who have referred to health care medical centers for the first time to make medical record for their current pregnancy
Finishing at least fifth elementary school level and access and the possibility of using cyberspace
Being possible to access him for at least the next 10 weeks.
Exclusion criteria:
previous history of screening or diagnostic tests for fetal chromosomal abnormalities
employment of research units in health centers
have a fetus with Down syndrome or abnormalities
history of known mental disorders, or taking psychiatric drugs
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
159
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted-Blok Randomization. In this way, all possible modes for placing the letters A, B and C in the blocks will be considered.
The size of the blocks is randomly selected by the computer (for example, blocks of size 6, 9, 12, and 18 are available in each block with equal numbers of each letter (group)). This will eliminate the possibility of revealing the last allocation in each block by randomly selecting the blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
People in the control group are told that they have been surveyed to achieve the study goals. Both intervention groups receive group training virtually, but are not aware of other group training.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and midwifery & Rehabitation; Tehran University of Medical Scienses
Street address
Nosrat street; Tohid square
City
Tehran
Province
Tehran
Postal code
141973317
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.TUMS.FNM.REC.1397.099
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Worry
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score in the Spilberger Anxiety Short Form Questionnaire
Timepoint
Before the start of the study and in the 14th and 20th weeks of pregnancy
Method of measurement
the Spilberger Anxiety Short Form Questionnaire
2
Description
Concern Score in Cambridge Worry Scale
Timepoint
Before the start of the study and in the 14th and 20th weeks of pregnancy
Method of measurement
Cambridge Worry Scale
Secondary outcomes
empty
Intervention groups
1
Description
For (Group A), the intervention will be designed as group training counseling through cyberspace. This virtual- group counseling is held at two-day intervals in three 45-minute sessions with 6 to 8 pregnant women. The content of the intervention is: Introducing the researcher to the participants. People briefly introduce themselves in the group The purpose of the training session is to introduce (familiarity with fetal screening tests and methods). Introduction of different types of screening tests including: 1- Combination screening test of the first trimester 2-Screening test of the second trimester 3- Non-invasive perinatal test Explain the nature of laboratory screening. Schedule scheduling tests Interpretation of screening test results (concept of chance or probability). How to track according to the results of the experiments. Explanation of diagnostic methods (chorionic villus sampling sampling and amniocentesis) including: technique, timing, possible risks. Description of termination or continuation of pregnancy, including: signs and symptoms and characteristics of children with Down syndrome; Conditions for the care of a child with disabilities due to cultural, social and government assistance; Legal and religious conditions for termination of pregnancy in Iran. This content will be presented in the first session as a lecture by the researcher to the participants in the session. In the next session, the researcher will answer the participants' questions and provide the group with a written file of the same content. In the third session, while removing the ambiguities of the participants and answering their possible questions, a PowerPoint file with pictures and educational tables will be provided to the participants.
Category
Prevention
2
Description
Intervention group B: group educational-psychological counseling. The intervention is designed as a group-educational-psychological group consultation in three 45-minute sessions with the presence of 6 to 8 pregnant women and with two-day intervals. In the first session, the same educational content prepared for group A will be presented as a speech, and at the end of the session, a written file with the content of the first session speech will be provided to the group. In the second session, the first and second parts of the psychological intervention will be performed. In the third session, the third part of the psychological intervention will be performed, the assignments of the previous session will be reviewed and the questions and ambiguities of the participant will be answered, and the PowerPoint file with educational and psychological content along with pictures and tables will be provided.
Category
Prevention
3
Description
Control group: They do not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-Asr Hospital in Imam Khomeini Hospital Complex
Full name of responsible person
Mitra Arjmandifar
Street address
School of Nursing and Midwifery; Nosrat street; Tohid square
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 5592 0380
Email
arj7087@yahoo.com
Web page address
https://fnm.tums.ac.ir/
2
Recruitment center
Name of recruitment center
Yas General Hospital
Full name of responsible person
Mitra Arjmandifar
Street address
School of Nursing and Midwifery; Nosrat street; Tohid square
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 5592 0380
Email
arj7087@yahoo.com
Web page address
https://fnm.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Sixth floor, Deputy of Research and Technology, University headquarters, at the corner of Quds street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/#
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mitra Arjmandifar
Position
PhD student of reprodactive health at Tehran University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Tehran University of Medical Science, School of Nursing and Midwifery, Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 5592 0380
Email
arj7087@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mitra Arjmandifar
Position
PhD student in reproductive health in Tehran University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Tehran University of Medical Science, School of Nursing and Midwifery, Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 5592 0380
Email
arj7087@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mitra Arjmandifar
Position
PhD student in reproductive health in Tehran University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Tehran University of Medical Science, School of Nursing and Midwifery, Nosrat street, Tohid square
City
Tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 5592 0380
Email
arj7087@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A part of the data, such as information about the main consequence or the like, can be shared.
When the data will become available and for how long
It is possible to access the results 6 months after publication
To whom data/document is available
It will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only in order to be aware of the research process by academic researchers
From where data/document is obtainable
Email address: Mitra Arjomandi Far
arj7087@yahoo.com
What processes are involved for a request to access data/document
Up to one month after receiving the request by email