Protocol summary

Study aim
Determining the effectiveness of midwifery counseling in a "supportive" way on stress and anxiety caused by the Covid 19 epidemic in pregnant women.
Design
This study is a parallel clinical trial with a control group on 100 pregnant women And using the allocation sequence, which is produced based on the block method of volume 4, the participants are randomly assigned to two groups.
Settings and conduct
First, Gorgan city is divided into three classes in terms of socio-economic status and two health centers are randomly selected from each floor and according to the volume covered by each class, participants are randomly selected from among pregnant women referring to the centers.
Participants/Inclusion and exclusion criteria
Having a health record in health centers Pregnant women with a gestational age of 6 to 32 weeks age range 35-18 Primary education level up Wanting to get pregnant Mental disability No hearing or vision problems No addiction to cigarettes, drugs and alcohol No recurrent miscarriage and history of infertility Ability to participate in training classes if classes are held virtually Access to cyberspace and the Internet High-risk pregnancy) History of serious psychiatric illness History of anxiety problems
Intervention groups
Referral pregnant women will be randomly assigned to two A / B groups (intervention A and control B); In the control group, except for completing the questionnaires and receiving routine pregnancy care, the intervention center will not do it, and in the intervention group, they will be consulted individually and face to face by the project manager in a room in the same center; Support counseling during two 60-minute sessions; The goals of support counseling include a) improving self-esteem b) improving self-efficacy c) and maximizing adaptive skills.
Main outcome variables
Covid 19 stress and anxiety in pregnant women.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210120050092N1
Registration date: 2021-02-19, 1399/12/01
Registration timing: registered_while_recruiting

Last update: 2021-02-19, 1399/12/01
Update count: 0
Registration date
2021-02-19, 1399/12/01
Registrant information
Name
Mina Eteraf
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3213 3260
Email address
mina_eteraf26@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of "supportive" midwifery counseling on stress and anxiety Due to the Covid 19 epidemic in pregnant women.
Public title
Evaluation of stress and anxiety due to Covid 19 epidemic in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a health record in health centers Pregnant women with a gestational age of 6 to 32 weeks age range 35-18Sal Primary education level up Wanting to get pregnant Mental disability No hearing or vision problems No addiction to cigarettes, drugs and alcohol No recurrent miscarriage and history of infertility Ability to participate in training classes if classes are held virtually Access to cyberspace and the Intern
Exclusion criteria:
High-risk pregnancy (twin or multiple, threat of miscarriage, recurrent miscarriage, history of infertility, history of preterm or threatened preterm delivery, gestational diabetes, preeclampsia, bleeding) History of serious psychiatric illness History of anxiety problems
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: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Using the allocation sequence, which is generated based on the block method of volume 4, participants are randomly assigned to two groups. This method was used because people enter the study over time and in order to be assigned to the groups in proportion to the accident over time, and also by assigning one person to one group, it is not possible to guess which group the next person will belong to. After generating the assignment sequence, each sequence letter (A, B) corresponds to a group. As participants enter the study from different centers, the central concealment method is used. The assignment sequence is placed in the hands of someone outside the research team. For each eligible person, after registering and entering the study, the desired person will be contacted and thus entered in a central list and will receive an identification code and assigned to the desired group. • 1, 4, 1, Group B • 1, 4, 2, Group B • 1, 4, 3, Group A • 1, 4, 4, Group A • 2, 4, 1, Group B • 2, 4, 2, Group A • 2, 4, 3, Group A • 2, 4, 4, Group B • 3, 4, 1, Group A • 3, 4, 2, Group B • 3, 4, 3, Group B • 3, 4, 4, Group A • 4, 4, 1, Group A • 4, 4, 2, Group B • 4, 4, 3, Group B • 4, 4, 4, Group A • 5, 4, 1, Group B • 5, 4, 2, Group B • 5, 4, 3, Group A • 5, 4, 4, Group A • 6, 4, 1, Group A • 6, 4, 2, Group B • 6, 4, 3, Group B • 6, 4, 4, Group A • 7, 4, 1, Group B • 7, 4, 2, Group A • 7, 4, 3, Group A • 7, 4, 4, Group B • 8, 4, 1, Group B • 8, 4, 2, Group B • 8, 4, 3, Group A • 8, 4, 4, Group A • 9, 4, 1, Group B • 9, 4, 2, Group B • 9, 4, 3, Group A • 9, 4, 4, Group A • 10, 4, 1, Group B • 10, 4, 2, Group A • 10, 4, 3, Group B • 10, 4, 4, Group A • 11, 4, 1, Group B • 11, 4, 2, Group A • 11, 4, 3, Group B • 11, 4, 4, Group A • 12, 4, 1, Group B • 12, 4, 2, Group A • 12, 4, 3, Group A • 12, 4, 4, Group B • 13, 4, 1, Group A • 13, 4, 2, Group B • 13, 4, 3, Group A • 13, 4, 4, Group B • 14, 4, 1, Group A • 14, 4, 2, Group A • 14, 4, 3, Group B • 14, 4, 4, Group B • 15, 4, 1, Group A • 15, 4, 2, Group A • 15, 4, 3, Group B • 15, 4, 4, Group B • 16, 4, 1, Group B • 16, 4, 2, Group A • 16, 4, 3, Group B • 16, 4, 4, Group A • 17, 4, 1, Group B • 17, 4, 2, Group A • 17, 4, 3, Group A • 17, 4, 4, Group B • 18, 4, 1, Group B • 18, 4, 2, Group B • 18, 4, 3, Group A • 18, 4, 4, Group A • 19, 4, 1, Group B • 19, 4, 2, Group B • 19, 4, 3, Group A • 19, 4, 4, Group A • 20, 4, 1, Group A • 20, 4, 2, Group A • 20, 4, 3, Group B • 20, 4, 4, Group B • 21, 4, 1, Group A • 21, 4, 2, Group B • 21, 4, 3, Group B • 21, 4, 4, Group A • 22, 4, 1, Group B • 22, 4, 2, Group A • 22, 4, 3, Group A • 22, 4, 4, Group B • 23, 4, 1, Group B • 23, 4, 2, Group A • 23, 4, 3, Group A • 23, 4, 4, Group B • 24, 4, 1, Group A • 24, 4, 2, Group A • 24, 4, 3, Group B • 24, 4, 4, Group B • 25, 4, 1, Group B • 25, 4, 2, Group B • 25, 4, 3, Group A • 25, 4, 4, Group A
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 Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences and Health Services- 7th of Tir Square- Shahroud
City
shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2021-02-07, 1399/11/19
Ethics committee reference number
IR.SHMU.REC.1399.172

Health conditions studied

1

Description of health condition studied
Stress caused by the Covid epidemic in pregnant women
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Anxiety caused by the Covid epidemic in pregnant women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Covid 19 stress in pregnant women
Timepoint
First before the intervention and then 4 weeks after the end of the intervention.
Method of measurement
Corona Virus Stress Scale Questionnaire

2

Description
Anxiety caused by Covid 19 in pregnant women
Timepoint
First before the intervention and then 4 weeks after the end of the intervention.
Method of measurement
Coronavirus Anxiety Scale Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: pregnant women
Category
N/A

2

Description
Control group:
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health service centers of Gorgan city.
Full name of responsible person
mina eteraf
Street address
Next to the Islamic Propaganda Organization, Razi St.- Shahid Rajaei St, Martyrs Square
City
gorgan
Province
Golestan
Postal code
۷۴۵۱۵ - ۴۹۳۴۱
Phone
+98 17 3268 4711
Email
Info@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
mohammad hasan emamiyan
Street address
Shahroud University of Medical Sciences and Health Services - 7th of Tir Squar - Shahroude
City
shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۵۵
Phone
+98 23 3239 6714
Fax
+98 23 3239 4852
Email
emamian@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
mina eteraf
Position
Master student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
vahed 5, sakhteman 111, golbarg 5, Golha
City
gorgan
Province
Golestan
Postal code
4915614731
Phone
+98 17 3213 3260
Email
mina_eteraf26@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
mina eteraf
Position
Master student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
vahed 5, sakhteman 111, golbarg 5, Golha
City
gorgan
Province
Golestan
Postal code
4915614731
Phone
+98 17 3213 3260
Email
mina_eteraf26@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
mina eteraf
Position
Master student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
vahed 5, sakhteman 111, golbarg 5, Golha
City
gorgan
Province
Golestan
Postal code
4915614731
Phone
+98 17 3213 3260
Email
mina_eteraf26@yahoo.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
Yes - There is 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
Regarding participants' personal data, information about the initial outcome is shared.
When the data will become available and for how long
Access time 6 months after the results are published.
To whom data/document is available
Researchers are allowed to receive data.
Under which criteria data/document could be used
The use of available pain data to advance the objectives of the study is permitted.
From where data/document is obtainable
They can be contacted via the following email to receive information. mina_eteraf26@yahoo.com
What processes are involved for a request to access data/document
The applicant's request will be answered within a week.
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