The effect of self care counseling on self care practice and health locus of control belief in pregnant women aged 35 years or more in the test and control groups
Determining the effect of self care counseling on the self care practice and health locus of control belief in pregnant women aged 35 years or older referring to Hamadan health centers
Design
In this study, at first 100 pregnant women aged 35 years or over with inclusion criteria were selected convenience sampling and then they were randomly divided into two test and control groups.
Settings and conduct
Type of research: The present study is a semi-experimental two-group (test and control) with pre-test and post-test design.
Research area: All Health Centers in Hamadan city.
The population of the study included all pregnant women aged 35 or over who will be referred to Hamadan Health Centers.
The research sample consists of a group of people in the research community who have criteria for entry into the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes:
Pregnant women with 35 years or more; having no underlying illnesses; single pregnancy; gestational age more than 24 weeks; have primary and higher literacy.
Exclusion criteria includes:
- Having no complete health based on medical records.
Intervention groups
Participants will be divided into test and control groups. In the test group, 4 consecutive 2-hour counseling sessions will be done. There will be no intervention in the control group.
Main outcome variables
Self care practice
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120821010635N3
Registration date:2017-12-28, 1396/10/07
Registration timing:prospective
Last update:2017-12-28, 1396/10/07
Update count:0
Registration date
2017-12-28, 1396/10/07
Registrant information
Name
Soodabeh Aghababaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0150
Email address
aghababaii@yahoo.com
Recruitment status
Recruitment complete
Funding source
Hamadan Medical University
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self care counseling on self care practice and health locus of control belief in pregnant women aged 35 years or more in the test and control groups
Public title
The effect of self care counseling on self care practice and health locus of control belief in pregnant women aged 35 years or older
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria includes: Pregnant women with 35 years or more; having no underlying illnesses; single pregnancy; gestational age more than 24 weeks; Have primary and higher literacy.
Exclusion criteria:
Exclusion criteria includes: Having not complete health based on medical records.
Age
From 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
In this study, the participants at first will be selected by simple sampling method and then will be divided randomly into control and experimental groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of University of Hamadan Medical Sciences
Street address
University of Hamadan Medical Sciences, Shahid Fahmideh Ave, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
65178-3-8698
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
IR.UMSHA.REC.1396.484
Health conditions studied
1
Description of health condition studied
Self care
ICD-10 code
Z40- Z54
ICD-10 code description
Persons encountering health services for specific procedures and health care
Primary outcomes
1
Description
Self care score
Timepoint
At the beginning of the study (before the intervention) and 30 days after the end of the intervention.
Method of measurement
Use the Health Practice Ouestionnaire
2
Description
Health Locus of Control score
Timepoint
At the beginning of the study (before the intervention) and 30 days after the end of the intervention.
Method of measurement
Use the Health Locus of Control ُScale (HLC)
Secondary outcomes
empty
Intervention groups
1
Description
"Test group": The counseling schedule will take place in the form of GATHER, so that after greetings and establishing a good relationship with mothers and greeting (G), asking the mothers open questions about themselves to help them think and reflect on the subject of the study. Give references to the wishes and needs and help mothers express their feelings and beliefs and get information about the risk of pregnancy and its complications (A) and provide the necessary explanation (T). Second session (45-60 minutes): To help the research units to increase the information about self-care during pregnancy and how to control health by emphasizing its internal aspect, counseling in La The ground will be presented. Identify the negative thoughts and misconceptions about health. Help (H) The third session (45-60 minutes): During this session, while reviewing the topics of the previous sessions and answering the questions, counseling on self-care during pregnancy and your individual role in health care. Educational pamphlets and educational explanations (E), scheduling for a visit to mothers, determining the next visit, if necessary, and explaining to the mother about follow-up times and weekly contacts (R). There will be no intervention in the control group.
Category
Lifestyle
2
Description
"Control group": There will be no intervention in the control group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Hamadan Medical Sciences
Full name of responsible person
Soodabeh Aghababaei
Street address
University of Hamadan Medical Sciences, Shahid Fahmideh Ave, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
65178- 38698
Phone
+98 81 3838 0150
Email
aghababaii@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
University of Hamadan Medical Sciences, Shahid Fahmideh Ave, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
65178- 38698
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Soodabeh Aghababaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
University of Hamadan Medical Sciences, Shahid Fahmideh Ave, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
65178- 38698
Phone
+98 81 3838 0150
Fax
Email
aghababaii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Hamadan Medical Sciences
Full name of responsible person
Soodabeh Aghababaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
University of Hamadan Medical Sciences, Shahid Fahmideh Ave, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
65178- 38698
Phone
+98 81 3838 0150
Fax
Email
aghababaii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Hamadan Medical Sciences
Full name of responsible person
Soodabeh Aghababaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
University of Hamadan Medical Sciences, Shahid Fahmideh Ave, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
65178- 38698
Phone
+98 81 3838 0150
Fax
Email
aghababaii@yahoo.com
Web page address
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
In this research, after the initial permission of individuals and their unidentified, research data will be shared.
When the data will become available and for how long
The data will be shared after the statistical analysis from the second half of 1397.
To whom data/document is available
Data will be shared by researchers in relevant fields.
Under which criteria data/document could be used
Any use of data will be subject to obtaining permission from Hamadan University of Medical Sciences.
From where data/document is obtainable
Responsive name is Dr. Soodabeh Aghababii, Faculty Member of University of Hamadan Medical Sciences.
E-mail: aghababaii@yahoo.com
What processes are involved for a request to access data/document
Data will be available upon notification of the respondent.