the effect of self-care education on anxiety and depression in pregnant women with a history of spontaneous abortion referring to health care center in Zahedan 2019
The present study was conducted to investigate the effect of self-care training on anxiety and depression in pregnant women with a history of spontaneous abortion.
Design
This randomized quasi-experimental study was performed on 90 pregnant women with a history of spontaneous abortion who referred to health centers in Zahedan in 2019. The samples were selected by convenience sampling method and randomly assigned to two intervention and control groups. The selected individuals were randomly assigned to intervention and control groups. To this end, some papers were placed in a box with the word "intervention on half of which” and the rest were "control ". Each person picked up a piece of paper from inside the box, and the individuals were randomly assigned to intervention and control groups.
Settings and conduct
Both groups took pre-test groups by completing a personal and fertility information questionnaire, a 6-item Spiel Berger questionnaire, and a short form of Beck Depression Questionnaire. Thereafter, face-to-face training sessions were provided for the intervention group during four 60-minute sessions over two weeks at the Comprehensive Health Centers.
Participants/Inclusion and exclusion criteria
The inclusion criteria entailed: 1) normal and singleton pregnancy, 2) a history of only one spontaneous abortion, 3) pregnancy between 6 and 16 weeks, the exclusion criteria included: absence in training programs for more than one session.
Intervention groups
Face-to-face training sessions were provided for the
intervention group during four 60-minute sessions over two weeks at the Comprehensive Health Centers, and a training booklet was delivered to them. On the other hand, the control group only received the usual pregnancy training in the form of prenatal care.
Main outcome variables
Comparison of anxiety and depression score between two groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200509047363N1
Registration date:2020-05-16, 1399/02/27
Registration timing:retrospective
Last update:2020-05-16, 1399/02/27
Update count:0
Registration date
2020-05-16, 1399/02/27
Registrant information
Name
Fateme Hashemzehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 4433 8224
Email address
fatemehashemzehi6350@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-01, 1398/07/09
Expected recruitment end date
2019-12-30, 1398/10/09
Actual recruitment start date
2019-10-01, 1398/07/09
Actual recruitment end date
2019-12-21, 1398/09/30
Trial completion date
2019-12-30, 1398/10/09
Scientific title
the effect of self-care education on anxiety and depression in pregnant women with a history of spontaneous abortion referring to health care center in Zahedan 2019
Public title
the effect of self-care education on anxiety and depression in pregnant women with a history of spontaneous abortion referring to health care center in Zahedan 2019
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
normal and singleton pregnancy
a history of only one spontaneous abortion
pregnancy between 6 and 16 week
lack of known mental disorder;addiction
lack of social -psychological crisis; such as the death of loved ones or physical problem and serious illness in the last 6 month
Patient Health Questionnaire-9 score of 8-15 ( moderate)
Exclusion criteria:
the occurrence of pregnancy problems ; end of pregnancy
absence in training programs for more than one session
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The selected individuals were randomly assigned to intervention and control groups. To this end some papers were placed in a box with the word "intervention on half of which and the rest were "control ". Each person picked up a piece of paper from inside the box; and the individuals were randomly assigned to intervention and control groups.
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
Zahedan University of Medical Sciences
Street address
Doctor Hesabi Squ; Daneshgah Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-09-15, 1398/06/24
Ethics committee reference number
IR.ZAUMS.REC.1398.239
Health conditions studied
1
Description of health condition studied
spontaneous abortion
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion
2
Description of health condition studied
disorder anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
3
Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
anxiety
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Spielberger State-Trait Anxiety Inventory
2
Description
depression
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Face-to-face training sessions were provided for the intervention group during four 60-minute sessions over two weeks at the Comprehensive Health Centers, and a training booklet was delivered to them.
Category
Treatment - Other
2
Description
Control group: The control group only received the usual pregnancy training in the form of prenatal care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Javad Health Center
Full name of responsible person
Mrs Zargari
Street address
Razi Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Email
fatemehashemzehi6350@gmail.com
2
Recruitment center
Name of recruitment center
Erfan Health Care Center
Full name of responsible person
Mrs Mir
Street address
Mehrshahr
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Email
fatemehashemzehi6350@gmail.com
3
Recruitment center
Name of recruitment center
Emam Hasan Health Care Center
Full name of responsible person
Mrs Rigi
Street address
Karimpour Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Email
fatemehashemzehi6350@gmail.com
4
Recruitment center
Name of recruitment center
Valiasr Health Care Center
Full name of responsible person
Mrs Salari
Street address
Majdie Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Fax
Email
fatemehashemzehi6350@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nour Mohammad Bakhshani
Street address
Dr Hesabi 'Zahedan University of Medical Sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
712234556
Phone
+98 54 3329 5792
Email
fatemehashemzehi6350@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Hashemzehi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashahir Squ. Nursing and Midwifery School
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
0985433442482
Email
fatemehashemzehi6350@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Tahereh Boryri
Position
science committee
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Mashahir Squ. Nursing and Midwifery School
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
boryri_tahereh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Fateme Hashemzehi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Mashahir Squ. Nursing and Midwifery School
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816913396
Phone
+98 54 3344 2482
Email
fatemehashemzehi6350@gmail.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
After making people unrecognizable
When the data will become available and for how long
6 Month after publication of the article
To whom data/document is available
university researchers
Under which criteria data/document could be used
For use in academic and scientific studies and research
From where data/document is obtainable
Fateme Hashemzehi
fatemehashemzehi6350@gmail.com
What processes are involved for a request to access data/document
Send a request to fatemehashemzehi6350#gmail.com and reply within 48 hour