Protocol summary

Study aim
Determining and comparing the effect of personal counseling and home visits on the level of self-care adherence of pregnant mothers
Design
This study was a clinical trial study. Ninety women with first pregnancies, who were single pregnancy and had a gestational age of 26-32 weeks, were randomly divided into three groups of control, first and second experimental groups, according to the inclusion criteria.
Settings and conduct
This study is a clinical trial study conducted in Kermanshah. The target population included women with the first pregnancy referred to health centers in Kermanshah who were in the third trimester of pregnancy (26-32 weeks) and had inclusion criteria. Ninety pregnant women were selected as a cluster from Kermanshah and were randomly divided into two experimental groups and a control group. The first and second experimental groups, in addition to routine care, underwent 5 sessions of individual counseling and 5 sessions of home visits, respectively, and in the control group, only routine care was performed. Mothers in the three groups were assessed before and after the intervention using the Hart Self-Care Adherence Questionnaire.
Participants/Inclusion and exclusion criteria
Resident of Kermanshah; Has a minimum literacy; Willingness to participate in the study; Gestational age between 26-26 weeks; First pregnancy; single pregnancy; No cognitive disorders or mental illness; No pregnancy complications
Intervention groups
The first intervention group, in addition to the routine care of the centers, 5 individual counseling sessions per week, one session 50-60 The second intervention group, in addition to the routine care of the centers, 5 sessions of home visits (weekly for 5 consecutive weeks) Control group, routine care centers
Main outcome variables
Adherence to self-care of pregnant mothers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201202049574N1
Registration date: 2020-12-29, 1399/10/09
Registration timing: retrospective

Last update: 2020-12-29, 1399/10/09
Update count: 0
Registration date
2020-12-29, 1399/10/09
Registrant information
Name
Maryam Sayadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3822 1404
Email address
data6670@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
2020-05-20, 1399/02/31
Actual recruitment end date
2020-09-20, 1399/06/30
Trial completion date
2020-11-21, 1399/09/01
Scientific title
A comparative study of the effect of personal counseling and home visits on the level of self-care of pregnant mothers
Public title
Tthe effect of personal counseling and home visits on the level of self-care of pregnant mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant mothers first pregnancies gestational age of 26-32 weeks singletons pregnancy Being a resident of Kermanshah city Has a minimum of elementary level Absence of speech and hearing disorders Lack of cognitive impairment or mental illness
Exclusion criteria:
Premature delivery before the end of the study Complications of pregnancy that cause hospitalization Reluctance to continue collaborating in research
Age
From 20 years old to 35 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
Using a numbered card, the samples were randomly divided into three groups (two test groups and one control group). Initially, three cards with the letters of the English alphabet written on them; Each was placed separately in an envelope. The control group (C), the first test group - counseling (M) and the second test group - home visit (H). The first three participants were then asked to each take one of the envelopes and open the card inside. Based on the letters on the cards, the control (C), the first test (M) and the second test (H) groups were identified. At the end of sampling, the samples were entered into groups in the same way and in the same way.
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 Kermanshah University of Medical Sciences
Street address
Research Deputy, Building No. 2, Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Approval date
2019-05-20, 1398/02/30
Ethics committee reference number
IR.KUMS.REC.1398.196

Health conditions studied

1

Description of health condition studied
Pregnancy
ICD-10 code
Z34.03
ICD-10 code description
Encounter for supervision of normal first pregnancy, third trimester

Primary outcomes

1

Description
Hart's Self-Care Adherence Score Questionnaire
Timepoint
Before the intervention and 4 weeks after the last intervention session
Method of measurement
Hart Self-Care Adherence Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: In addition to routine care centers, 5 individual counseling sessions, one session per week
Category
Prevention

2

Description
Intervention group 2: In addition to the routine care of the centers, 5 sessions of home visit, one session per week
Category
Prevention

3

Description
Control group: Routine health care related to pregnancy
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah health centers
Full name of responsible person
Maryam Sayadi
Street address
Midwifery department, Imam Reza hospital, Parstar Blvd., Sorkheh Lijeh
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6345
Email
data6670@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Research Deputy, Building No. 2, Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3836 0016
Email
data6670@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Sayyadi
Position
Midwifer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Midwifery department, Imam Reza Hospital,Parstar Blvd.,Sorkheh Lijeh
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3425 6347
Email
data6670@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Sayyadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Midwifery department, School of Nursing and Midwifery, Dolatabad, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415153
Phone
+98 83 3816 2572
Email
Khalily1267@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Sayyadi
Position
Midwifer
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Midwifery department, Imam Reza Hospital, Parstar Blvd., Sorkheh Lijeh
City
Kermanshah
Province
Kermanshah
Postal code
6742775333
Phone
+98 83 3427 6345
Email
data6670@yahoo.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
Undecided - It is not yet known if there will be 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
Some of the participants' data will be shared with the subscriber in the form of dissertation and article reports after making them unidentifiable.
When the data will become available and for how long
Start of access period from the beginning of 2021
To whom data/document is available
Real people working in academic and scientific institutions
Under which criteria data/document could be used
Only the results of data analysis mentioned in the dissertation can be used.
From where data/document is obtainable
Sorkheh Lijeh, Parstar Blvd.,Imam Reza Hospital, Midwifery, Maryam Sayadi
What processes are involved for a request to access data/document
A written request or email to Ms. Maryam Sayadi is sufficient to use the documents.
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