Determining the Effect of self-care education in pregnancy with perceived stress and social support Preeclampsia
Design
population of the study is women with Preeclampsia who are referred to the research environment at the time of study.According to the population covered by each clinic, the number of samples will be calculated for each clinic. The sample size is 96 people (each case and control group, 48 people).
Samples are included in the study by available sampling method and after obtaining written consent.
Settings and conduct
The research environment of the selected hospitals in Shiraz. The reason for choosing this environment is easy access to the sample. According to the population covered by each clinic, the number of samples will be calculated for each clinic.
Samples are included in the study by available sampling method and after obtaining written consent. Data is obtained through self-care questionnaire, stress and perceived social support. The researcher completes the questionnaires by conducting the interview.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Iranian nationality; Women with Preeclampsia ; 18-45 years old; Pregnant age 20 to 42 weeks; Singleton pregnancy; No history of neonatal death in previous pregnancies; The number of deliveries is less than 4; Lack of chronic diseases; Residence in Shiraz for attending educational classes. Exclusion criteria: History of blood pressure; Dissatisfaction of people.
Intervention groups
A self-care education group will be provided and then self-care questionnaire, stress and socially perceived social support will be completed. The control group completes questionnaires without any training.
Main outcome variables
perceived stress and social support
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180127038526N1
Registration date:2018-05-01, 1397/02/11
Registration timing:prospective
Last update:2018-05-01, 1397/02/11
Update count:0
Registration date
2018-05-01, 1397/02/11
Registrant information
Name
Fatemeh Ahmadinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3229 5884
Email address
ahmadi_776@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2018-07-06, 1397/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education in pregnancy with perceived stress and perceived social support in patients with Preeclampsia
Public title
The effect of self-care education in pregnancy with perceived stress and social support in patients with Preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian nationality
pregnant women with preeclampsia
18-45 years old
pregnant age 20 to 42 weeks
No history of neonatal death in previous pregnancies
The number of deliveries is less than 4
Lack of chronic diseases such as: diabetes, severe obesity, kidney disease, cardiovascular disease, anemia
Lack of mental illness
residence in Shiraz for attending educational classes
Exclusion criteria:
History of Prepregnancy blood pressure
Dissatisfaction of people
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
The research environment of this study was clustered in three hospitals (mother and child clinics of Shooshtari and Hafez and Zainabiyeh Hospitals). Hospitals were selected randomly in a draw. Then, the proportion of the population covered by each clinic was calculated for each clinic. Samples are included in the sampling method. The samples are women with pre-eclampsia who at the time of study are randomly referred to the research environment and have criteria for entering the study.
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 Shiraz University of Medical Sciences
Street address
Zand Ave., Al-Crescent, Central Branch of the University of Medical Sciences, Dept. of Research Shiraz, Fars, Iran 1978 -71345
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.SUMS.REC.1396,144
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O14.9
ICD-10 code description
Unspecified pre-eclampsia
Primary outcomes
1
Description
Perceived stress: The phenomenon of stress in the very general sense is the psychological responses to the psychological and physical needs and threats (stressors). According to Cohen's definition of stress, when the needs of the environment, whether internal or external, true or imagined, or greater than individual capacity, cause psychological and biological changes that pose a person at risk of disease.
Timepoint
Complete the questionnaire for the control group without any training and completion of the questionnaire for the case group after five sessions of Self-care education.
Method of measurement
Dass perceived stress questionnaire
2
Description
Perceived Social Support: Perceived support is equivalent to satisfying and having social support with positive emotions, and receiving social support is as much as the individual's enjoyment of obvious emotional support, such as the help and assistance provided by the family and friends, which can be measured in size The number of supporters and the level of access and enjoyment of the types of social support were determined.
Timepoint
After five self-care training sessions
Method of measurement
Perceived Social Support Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-care education: Intervention is self-care education, which will be provided to the intervention group in five sessions and each session for half an hour. Group meetings and training will be held in the form of a conference and question and answer session. Self-care education is based on self-care guidelines in health centers and contains information on the principles of nutrition and healthy lifestyle, the impact of physical activity and the manner of control and principles of prevention and treatment of hypertension. Finally, after completing the training sessions, the researcher completes self-care self-care questionnaire, stress and social support.
Category
Prevention
2
Description
Control group: This group of women with Preeclampsia without any training will complete self-care questionnaires, stress, and perceived social support through interviews.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shooshtari Hospital
Full name of responsible person
Fatemeh Ahmadi nezhad
Street address
Bascule Nader Ave.
City
Shiraz
Province
Fars
Postal code
7173775617
Phone
+98 71 3232 4805
Email
Ahmadi_776@yahoo.com
2
Recruitment center
Name of recruitment center
Zainab Hospital
Full name of responsible person
Fatemeh Ahmadi nezhad
Street address
Sacred Defense Square
City
Shiraz
Province
Fars
Postal code
7153813311
Phone
+98 71 3726 6811
Email
Ahmadi_776@yahoo.com
3
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Fatemeh Ahmadi nezhad
Street address
Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
7194634786
Phone
+98 71 3627 1531
Email
Ahmadi_776@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Ramin Niknam
Street address
Zand Street - Ahead of the Red Crescent - Central Station of the University of Medical Sciences - Class 7 - Research Deputy
City
Shiraz
Province
Fars
Postal code
43361- 71348
Phone
+98 71 3230 5410
Email
president@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Akbarzadeh
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Namazi Square, Faculty of Nursing and Midwifery
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Email
akbarzadm@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Ahmadi nezhad
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No.76, Allay 5, Jahad Sazandegi St., Gaz Sq.
City
Shiraz
Province
Fars
Postal code
7144663995
Phone
+98 712295884
Email
Ahmadi_776@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Ahmadi nezhad
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 76, Alley 5,, Jahad Sazandegi St., Gaz Sq.
City
Shiraz
Province
Fars
Postal code
7144663995
Phone
+98 71 3229 5884
Email
Ahmadi_776@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available