Protocol summary

Study aim
Determining the effect of self-care educational intervention on the empowerment of primigravida pregnant women covered by the family doctor program of Estehban city
Design
The present semi-experimental study on a sample of 40 primigravida pregnant women in the form of an intervention group who refer to the centers covered by the family doctor program in Estehban city to receive services, with the aim of improving their capabilities based on the Pender health promotion model, in a way direct (face-to-face consultation), during 6 sessions of 90 minutes and two sessions per week for the intervention group. Questionnaires will be completed by the samples before and one month after the intervention.
Settings and conduct
In one of the health centers, the educational program will be held in the form of 6 sessions for the intervention group.
Participants/Inclusion and exclusion criteria
Interested in participating in the study Pregnant mothers participating in the research must have at least reading and writing (primary) literacy. Have listening and speaking skills to participate in the study. be Iranian Without any known physical or mental illness that would prevent the pregnant woman from participating in the study. Do not belong to the high-risk group. Have not participated in childbirth preparation classes. Including pregnant women with a gestational age of 14-28 weeks Be primigravida
Intervention groups
Primigravida pregnant women in two control and intervention groups in separate health centers
Main outcome variables
Empowerment and its subscales (self-efficacy, future image, self-esteem, perceived social support, joy of being added to the family)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131014015015N23
Registration date: 2023-11-10, 1402/08/19
Registration timing: prospective

Last update: 2023-11-10, 1402/08/19
Update count: 0
Registration date
2023-11-10, 1402/08/19
Registrant information
Name
Leila Ghahremani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
ghahramanl@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation The Effect of Self-Care Educational Intervention on Empowerment of Primigravida Pregnant Women covered by The Family Doctor Program of Estahban City: an Application of The Pender Health Promotion Model
Public title
Effect of Self-Care Education on Empowerment of Primigravida Pregnant Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Interested in participating in the study Pregnant mothers participating in the research must have at least reading and writing (primary) literacy Have listening and speaking skills to participate in the study Be Iranian Without any known physical or mental illness that would prevent the pregnant woman from participating in the study Do not belong to the high-risk group Have not participated in childbirth preparation classes Including pregnant women with a gestational age of 14-28 weeks Be primigravida
Exclusion criteria:
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
For the generalizability of the study results and to reduce the socio-economic differences as much as possible, the samples of the two control and experimental groups were selected from 4 established health centers, completely randomly, 2 centers along with covered centers as the control group and two other health centers. It will be selected as the test group along with the covered centers. In the selected centers, the names of eligible people are listed from the apple system, and among the mothers eligible to enter the study, 40 people will be randomly selected as the control group and 40 people will be considered as the experimental 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 Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand St. Shiraz
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2023-11-02, 1402/08/11
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.000

Health conditions studied

1

Description of health condition studied
Empowerment of primigravida pregnant women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Empowerment
Timepoint
in two periods: before the intervention and one month after the intervention
Method of measurement
Kamda empowerment questionnaire

Secondary outcomes

1

Description
Self-efficacy
Timepoint
in two periods: before and one month after the educational intervention
Method of measurement
Kameda empowerment questionnaire

2

Description
future image
Timepoint
in two periods: before and one month after the educational intervention
Method of measurement
Kameda empowerment questionnaire

3

Description
self-esteem
Timepoint
in two periods: before and one month after the educational intervention
Method of measurement
Kameda empowerment questionnaire

4

Description
perceived social support
Timepoint
in two periods: before and one month after the educational intervention
Method of measurement
Kameda empowerment questionnaire

5

Description
joy of being added to the family
Timepoint
in two periods: before and one month after the educational intervention
Method of measurement
Kameda empowerment questionnaire

Intervention groups

1

Description
Intervention group: will be invited to participate in the study and the objectives of the study will be explained to them, after assuring them of the confidentiality of the information, informed consent will be obtained from them. will be brought in this study, for the purpose of educational intervention, in the intervention group, the implementation of the educational program will be conducted face-to-face and by the method of short lectures, group discussions, questions and answers according to the structures of the Pender model and using educational aids such as (pamphlets, showing educational clips). Pregnant women will be divided into small groups of 5 people and will receive 6 training sessions of 90 minutes. Questionnaires will be provided to them again one month later.
Category
Behavior

2

Description
Control group: They will not receive training during this period. Although, in order to comply with ethical considerations, the control group will be assured that after the completion of the research process, they will also receive this educational intervention. A month later, the questionnaires will be provided to them again.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Centers covered by the family doctor program of Estehban city
Full name of responsible person
Leila Ghahremani
Street address
Vakil Abad, health and treatment network of Estehban city
City
Estehban
Province
Fars
Postal code
74518-73981
Phone
+98 71 5324 2036
Email
estahbansh@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Research and Technology Deputy; 7th Floor; Central Building of Shiraz University of Medical Sciences; Zand Street
City
Shiraz
Province
Fars
Postal code
Phone
+98 71 3234 7966
Email
hashempurm@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
Leila Ghahramani
Position
Faculty member of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
First floor; building number one; School of Public Health; in front of Electricity Club; Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3725 1001
Email
lghahraman@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghahramani
Position
Faculty member of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
First floor; building number one; School of Public Health; in front of Electricity Club; Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3725 1001
Email
lghahraman@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghahramani
Position
Faculty member of Shiraz University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
First floor; building number one; School of Public Health; in front of Electricity Club; Razi Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3725 1001
Email
lghahraman@gmail.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
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