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InvestigatingThe effect of educational and Supportive intervention on health performance and general self-efficacy of pregnant adolescents

Protocol summary

Study aim
Determining the effectiveness of a part of the comprehensive program to improve reproductive health in pregnant teenagers
Design
The Clinical Trial has an intervention group and a control group with parallel groups and without blinding, randomization with permutation block (randomized blocks of four) on 136 pregnant teenagers.
Settings and conduct
In order to collect data, the clinic of Vali Asr Educational Hospital and Fasa Comprehensive Health Center are used. Training sessions are held in the conference room of the director's office located on the first floor of Vali Asr Hospital. After the registration of the Trial, the patients who meet the criteria for entering the study will be talked to and consent will be obtained from them to participate in the study. Before determining the type of random allocation of people, the questionnaires are completed. Based on four blocks, people are placed in groups A or B, and a training class is held for the intervention group, and the control group receives the routine intervention. .
Participants/Inclusion and exclusion criteria
inclusion criteria: Adolescents 10-19 years old married pregnant primigravida 18-24 weeks of pregnancy Willingness to participate in classes with accompanying attendance exclusion criteria: Having a high-risk pregnancy Experiencing an unfortunate incident within the last three months Having restrictions on physical movement Using medicine for a physical or mental problem
Intervention groups
Intervention group: holding six educational class sessions with questions and answers and creating a group on social networks to repeat what was said in the class and answer questions in the presence of pregnant teenagers and their companions and provide certificates for the companions regarding their attendance at the maternity hospital Control group: routine intervention
Main outcome variables
Health Performance General Self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230816059157N1
Registration date: 2023-08-28, 1402/06/06
Registration timing: registered_while_recruiting

Last update: 2023-08-28, 1402/06/06
Update count: 0
Registration date
2023-08-28, 1402/06/06
Registrant information
Name
Firoozeh Nourimand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5333 6950
Email address
firozeh.nourimand@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
InvestigatingThe effect of educational and Supportive intervention on health performance and general self-efficacy of pregnant adolescents
Public title
Investigating the effect of education and support on improving the reproductive health of pregnant adolescents
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents 10-19 years old Married Pregnant Primigravida 18-24 weeks of pregnancy Having a health file in the health centers of Fasa and its suburbs Having the ability to speak and understand Persian language Informed consent to participate in research Willingness to participate in classes with accompanying attendance
Exclusion criteria:
Having a high-risk pregnancy, including diabetes, high blood pressure, and chronic diseases affecting pregnancy such as cardiovascular disease, lung disease, etc., and History or current mental problems Experiencing a catastrophic life event in the past three months Having physical movement restrictions (heart disease, lung disease, incompetent cervix, high-risk multiple pregnancies, continuous bleeding, Placenta Previa after 26 weeks, Gestational blood pressure) Addiction to any kind of drugs, tobacco Receiving special medicine due to a physical or psychological problem
Age
From 10 years old to 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
Permutation block randomization method with blocks of four has been used. We assigned different permutations to numbers 1 to 6 in the following order. 1. AABB 2. ABAB 3. ABBA 4. BBAA 5. BABA 6. BAAB Now, using the table of random numbers, we extracted the numbers from the table, and depending on whether one of the numbers 1 to 6 came, each of the blocks assigned to these numbers was selected until 36 blocks of 4 were selected. If the numbers 0, 7, 8, and 9 came up, we ignored them and continued this order to provide a complete list for the entire sample size.
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 Shahroud University of Medical Sciences
Street address
Shahroud, 7 Tir Square - Shahroud University of Medical Sciences and Health Care Services
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۳
Approval date
2022-07-30, 1401/05/08
Ethics committee reference number
IR.SHMU.REC.1401.105

Health conditions studied

1

Description of health condition studied
-
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Health Performance and General Self-efficacy
Timepoint
Before the intervention - immediately after the end of the intervention - one month after the intervention
Method of measurement
Health practices questionnaire/ General Self-Efficacy Scale (Sherer et al)

Secondary outcomes

1

Description
Maternal and newborn outcomes such as high-risk pregnancy, birth weight of the baby, condition of the baby, type of delivery
Timepoint
immediately after child birth
Method of measurement
High-risk pregnancy (with/without), birth weight (Kg), condition of baby(hospitalization/Rooming in), type of delivery (NVD/cesarean section).

Intervention groups

1

Description
Intervention group: Educational class for pregnant teenagers with companions. The course will be held during 6 sessions of 60-90 minutes by the researcher in the conference hall of Vali Asr Hospital from the 25th week of pregnancy. Session intervals will be one week. The content of the class includes information about pregnancy and childbirth, pregnancy care, the effect of adequate sleep and rest, appropriate physical activity, proper diet, correct health practices, signs and symptoms of pregnancy, and teaching self-care behaviors and Self-efficacy to control distressing symptoms. The material said in the class will be repeated in the virtual network where the pregnant lady and her companion are members.
Category
Behavior

2

Description
Control group: The control group will receive routine prenatal care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive health center of Fasa city
Full name of responsible person
Mrs. Khosravi
Street address
Fasa- Blvd. Vali Asr- Department of Health
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Phone
+98 71 5335 0994
Fax
Email
info@fums.ac.ir
Web page address
https://www.fums.ac.ir/

2

Recruitment center
Name of recruitment center
Vali Asr Hospital Clinic
Full name of responsible person
Mrs. Moradi
Street address
Fasa, Ibn Sina square
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶-۸۶۶۸۸
Phone
+98 71 5331 4011
Email
valiasrfasa@fums.ac.ir
Web page address
https://vh.fums.ac.ir/contact_us

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mr. Dr. Emamian
Street address
Shahroud, 7 Tir Square - Shahrood University of Medical Sciences and Health Care Services
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 5054
Fax
+98 23 3239 5009
Email
info@shmu.ac.ir
Web page address
https://www.shmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Firoozeh Nourimand
Position
دانشجو
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Fasa city, Kanarestan Blvd., No. 32, 20 Alley
City
Fasa
Province
Fars
Postal code
7461858461
Phone
+98 71 5333 6950
Fax
Email
firozeh.nourimand@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Shahrabanoo Salehin
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Shahroud, 7 Tir Square - Shahroud University of Medical Sciences and Health Care Services
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۳
Phone
+98 23 3239 5054
Fax
Email
drbsalehin@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Firoozeh Nourimand
Position
دانشجو
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
Fasa city, Kanarestan Blvd., No. 32, 20 Alley
City
Fasa
Province
Fars
Postal code
7461858461
Phone
+98 71 5333 6950
Fax
Email
firozeh.nourimand@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
Information on primary and secondary outcomes can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
For researchers working in academic and scientific institutions and people participating in research
Under which criteria data/document could be used
Improving services to promote reproductive health in pregnant teenagers
From where data/document is obtainable
Mrs. Dr. Shahrabanoo Salehin 09126311433 Shahroud - Haft Tir Square - Shahroud University of Medical Sciences Postal code: 36147-73943 drbsalehin@gmail.com Firoozeh Nourimand 09357149135 Fasa-Kanarestan Boulevard, 20 Alley, No. 32 Postal code: 7461858461 firozeh.nourimand@gmail.com
What processes are involved for a request to access data/document
Six months after the completion of the plan, we will be responsive to the mentioned people by calling, emailing, or texting, and the necessary documents will be sent to them via email within seven working days.
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