The effect of the online child birth preparation classes on anxiety and the quality of life of pregnant women during covid-19 pandemy
Design
This research is a randomised clinical trial with two control and intervention group.50 pregnant women are selected randomly in each group.No blinding is done.
Settings and conduct
This research is a randomised clinical trial in Arash hospital.100 pregnant women are allocated to control and intervention group randomly.8 online educational sessions about birth preparation are held for intervention group.Control group receives just routine prenatal cares.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Gestational age between 20 weeks to 30 weeks
Access to the virtual space
Primary educations
Not attending in virtual and attendance birth preparation courses in current pregnancy
Non inclusion criteria:
Preterm delivery
suffering from mental disorders and depression before and during pregnancy
suffering from fetal and maternal health threatening diseases
Intervention groups
Intervention group:50 eligible pregnant women reffering to the prenatal clinic of Arash hospital are selected as intervention group.8 online educational sessions are held.
Control group:50 eligible pregnant women reffering to the prenatal clinic of Arash hospital are selected ascontrol group.Thi group receives just routine prenatal cares and after post test ، educational sessions are held for them.
Main outcome variables
Anxiety-Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190713044192N2
Registration date:2020-11-21, 1399/09/01
Registration timing:registered_while_recruiting
Last update:2020-11-21, 1399/09/01
Update count:0
Registration date
2020-11-21, 1399/09/01
Registrant information
Name
Zohreh Maleki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3348 4604
Email address
iris_decor_group@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the online child birth preparation classes on anxiety and the quality of life of pregnant women during COVID_19 pandemic
Public title
The effect of the online child birth preparation classes on pregnant women during COVID_19 pandemic
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age between 20 weeks -30 weeks
Access to virtual space
Primary education
Not attending in virtual and attendance child birth preparation courses in current pregnancy
Exclusion criteria:
Preterm delivery
suffering from psychological disorders and depression befor and during pregnancy
suffering from health threatening diseases in fetus and mother
Age
No age limit
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
In this research، systematic randomization is applied.Pregnant women who are reffered to prenatal clinic are asked to enroll if they are interested in .For determining the counting distance ، the number of enrolled women is divided to intended cases of the research .For choosing the first case، a number from 1 to 10 is selected randomly.This number is allocated to the first case.other cases are selected based on the counting distance till 100 cases are selected.A number is selected from 1 to 100. If this number is even، all the even numbers will be selected as intervention group and odd numbers will be selected as control 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 committee of Tehran university of medical science
Street address
Ghods street -Enghelab square
City
Tehran
Province
Tehran
Postal code
3439123900
Approval date
2020-09-15, 1399/06/25
Ethics committee reference number
IR.TUMS.FNM.REC.1399.098
Health conditions studied
1
Description of health condition studied
Anxiety and quality of life
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of Spielberger State-Trait questionnaire
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Spielberger State-Trait questionnaire
2
Description
Score of Quality of life questionnaire
Timepoint
Before the intervention and four weeks after the intervention
Method of measurement
Quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this research the intervention group consists of 50 eligible pregnant women reffering to the prenatal clinic of Arash hospital.After pretest، 8 virtual educational sessions about child birth preparation is held، Educational sessions are held every 3 days. Each session takes about 2 hours and the content is taught through power point، lecture and video.The content consists of introduction، anatomical and physiological changes in pregnancy، personal health، adaption to pregnancy changes، breathing techniques and relaxation، nutrition، mental health، painless delivery ، postpartum and neonate health.
Category
Other
2
Description
Control group: In this research the control group consists of 50 eligible pregnant women reffering to the prenatal clinic of Arash hospital.This group just receives routin prenatal cares and after post test، educational sessions are held.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash hospital
Full name of responsible person
Farnaz Farnam
Street address
Baghdarnia street- Farjam street- Tehranpars
City
Tehran
Province
Tehran
Postal code
1854213265
Phone
+98 21 7788 3288
Email
hos_arash@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Sahraeian
Street address
Ghods street- Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6405 3334
Email
tums_edu@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
Farnaz Farnam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tohid square- Facaulty of Midwifery and Nursing
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 4411
Email
f_farnam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnaz Farnam
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Tohid square-Facaulty of Midwifery and Nursing
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 4411
Email
f_farnam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohre Maleki
Position
Midwife
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Tohid square-Facaulty of Midwifery and Nursing
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 935 736 0033
Fax
Email
z_maleki63@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participant s informations are secret.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The final result will be accessible as an article on the accepted journal.
When the data will become available and for how long
No limited timespan
To whom data/document is available
No limitation
Under which criteria data/document could be used
Applying the result of this research is permissible just in cases of citations.
From where data/document is obtainable
For receiving data and documents، send an e-mail to this address:z_maleki63@yahoo.com
What processes are involved for a request to access data/document
Sending e-mail for requesting access to the data and document