Design, implementation, and evaluation of educational program based on saltuogenesis theory on fear of childbirth and choice of delivery method among nulliparous women: a sequential-exploratory mixed methods design
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Protocol summary
Design, implementation, and evaluation of educational program based on saltogenesis theory on fear of childbirth and choice of delivery method among nulliparous women
Design, implementation, and evaluation of educational program based on salutogenesis theory on fear of childbirth and choice of delivery method among nulliparous women
Design, implementation, and evaluation of educational program based on saltogenesissalutogenesis theory on fear of childbirth and choice of delivery method among nulliparous women
General information
empty
The fourth letter (u) of the Latin word salutogenesis was omitted.
The fourth letter (u) of the Latin word salutogenesis was omitted.
empty
چهارمین حرف (u) واژه لاتین سالتوژنز از قلم افتاده بود.
چهارمین حرف (u) واژه لاتین سالتوژنز از قلم افتاده بود.
Saltogenesis theory on fear of childbirth
Saltuogenesis theory on fear of childbirth
SaltogenesisSaltuogenesis theory on fear of childbirth
Design, implementation, and evaluation of educational program based on saltogenesis theory on fear of childbirth and choice of delivery method among nulliparous women: a sequential-exploratory mixed methods design
Design, implementation, and evaluation of educational program based on saltuogenesis theory on fear of childbirth and choice of delivery method among nulliparous women: a sequential-exploratory mixed methods design
Design, implementation, and evaluation of educational program based on saltogenesissaltuogenesis theory on fear of childbirth and choice of delivery method among nulliparous women: a sequential-exploratory mixed methods design
Recruitment centers
#1
Name of recruitment center - English: Comprehensive health service centers
Name of recruitment center - Persian: مراکز خدمات جامع سلامت
Full name of responsible person - English: Ramak Zavar Kaabeh
Full name of responsible person - Persian: رامک زوار کعبه
Street address - English: Bostan Abad HealthCare Network
Street address - Persian: خیابان امام خمینی، شبکه بهداشت درمان بستان آباد
City - English: Bostan Abad
City - Persian: بستان آباد
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5410177111
Phone: +98 41 4333 3238
Fax:
Email: kanani.safieh@yahoo.com
Web page address:
Name of recruitment center - English: Health Comprehensive Service Centers
Name of recruitment center - Persian: مراکز خدمات جامع سلامت
Full name of responsible person - English: Ramak Zavar Kaabeh
Full name of responsible person - Persian: رامک زوار کعبه
Street address - English: Bostanabad Health Network, Imam Khomeini Ave
Street address - Persian: خیابان امام خمینی، شبکه بهداشت درمان بستان آباد
City - English: Bostanabad
City - Persian: بستان آباد
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5410177111
Phone: +98 41 4333 3238
Fax:
Email: kanani.safieh@yahoo.com
Web page address:
Name of recruitment center - English: Health Comprehensive health service centersService Centers Name of recruitment center - Persian: مراکز خدمات جامع سلامت Full name of responsible person - English: Ramak Zavar Kaabeh Full name of responsible person - Persian: رامک زوار کعبه Street address - English: Bostan Abad HealthCareBostanabad Health Network, Imam Khomeini Ave Street address - Persian: خیابان امام خمینی، شبکه بهداشت درمان بستان آباد City - English: Bostan AbadBostanabad City - Persian: بستان آباد Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5410177111 Phone: +98 41 4333 3238 Fax: Email: kanani.safieh@yahoo.com Web page address:
Sharing plan
yes
undecided
yesundecided
Protocol summary
Study aim
Design, implementation, and evaluation of educational program based on salutogenesis theory on fear of childbirth and choice of delivery method among nulliparous women
Design
Eligible women are randomly selected based on their electronic health records.
Blocked randomization will be used to assign participants to two groups.
Envelopes are used to allocate concealment.
Settings and conduct
The educational intervention is held in 4 training sessions of at least 30 minutes in 4 groups of 6 people and 2 groups of 7 people, one day a week for each group at the Health Comprehensive Service Centers of Bostanabad city of East Azerbaijan by the researcher in face to face. All of the training sessions will be completed by the 16th- week gestation.
Participants/Inclusion and exclusion criteria
Primiparous pregnant women / Inclusion criteria: first trimester of pregnancy, 18-35 years, no history of self-reported depression or chronic illness, singleton pregnancy, ultrasound confirmation of fetal health, no history of miscarriage or stillbirth, lack of contraindications of vaginal delivery to termination of pregnancy, lack of midwifery base and related fields of study, having consent to participate in the study. Exclusion criteria: preterm delivery due to an emergency, indications of cesarean section, history of cesarean section, history of infertility, lack of continuous presence of pregnant women in training sessions, failure to complete the questionnaire, lack of access to the participant for any unpredictable reason.
Intervention groups
The intervention group will receive intervention designed based on the content of education obtained from the qualitative and review phases using lectures, group discussions, collaborative learning, a problem-solving workshop.
The Control group will receive routine pregnancy care.
Main outcome variables
Fear of childbirth and vaginal delivery choice
General information
Reason for update
The fourth letter (u) of the Latin word salutogenesis was omitted.
Acronym
IRCT registration information
IRCT registration number:IRCT20210506051202N1
Registration date:2021-08-21, 1400/05/30
Registration timing:prospective
Last update:2021-08-22, 1400/05/31
Update count:2
Registration date
2021-08-21, 1400/05/30
Registrant information
Name
Safieh Kananikandeh
Name of organization / entity
Tarbiat Modares Universuty
Country
Iran (Islamic Republic of)
Phone
+98 45 3278 1289
Email address
s.kananikandeh@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation, and evaluation of educational program based on saltuogenesis theory on fear of childbirth and choice of delivery method among nulliparous women: a sequential-exploratory mixed methods design
Public title
Saltuogenesis theory on fear of childbirth
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All primiparous pregnant women in the first trimester of pregnancy
18-35 years
High school and university
No history of self-reported depression or chronic illness
Singleton pregnancy
Ultrasound confirmation of fetal health
No history of miscarriage or stillbirth
Lack of contraindications of vaginal delivery to termination of pregnancy
Lack of midwifery base and related fields of study
Having consent to participate in the study
Exclusion criteria:
Preterm delivery due to an emergency
Indications for cesarean section
History of cesarean section
History of infertility
Lack of continuous presence of pregnant women in training sessions
Failure to complete the questionnaire
Lack of access to the participant for any unpredictable reason
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
For assigning participants to the two groups of intervention and control will be used blocked randomization method with the size of 4 and 6 blocks.
To allocate concealment, the type of intervention is written on paper by a person who has no role in sampling and analyzing the data.
These sheets of paper are placed inside identical matte envelopes in an appearance that will be numbered in order.
Upon arrival at the center, each participant receives an envelope from one of the coordinated health personnel.
Blinding (investigator's opinion)
Single blinded
Blinding description
To allocate concealment, the type of group will be written on a piece of paper by a person who will have no role in sampling and analyzing the data. These sheets are placed inside identical matte envelopes that will be numbered sequentially. Upon arrival at the center, each participant receives an envelope from one of the coordinated health personnel. In this way, each person will be in one of the control or intervention groups without knowing their group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tarbiat Modares University
Street address
Jalal AleAhmad Ave
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2021-06-26, 1400/04/05
Ethics committee reference number
IR.MODARES.REC.1400.097
Health conditions studied
1
Description of health condition studied
Fear of childbirth
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Reduce fear of childbirth
Timepoint
Before the intervention, immediately after the intervention and 6 months after the intervention
Method of measurement
Wijma Delivery Expectancy/Experience Questionnaire- A
2
Description
Choice of natural childbirth
Timepoint
Before the intervention, immediately after the intervention and 6 months after the intervention
Method of measurement
Checklist for choosing the delivery method
Secondary outcomes
1
Description
Sense of coherence
Timepoint
Before the intervention, immediately after the intervention and 6 months after the intervention
Method of measurement
Antonovsky Coherence Scale (SOC-13)
Intervention groups
1
Description
Educational content is prepared based on the main factors obtained from qualitative and review stages on the fear of childbirth in nulliparous women. Teaching methods include lecturing, group discussion, question and answer and collaborative learning, problem-solving, talking about positive experiences, and brainstorming. Educational tools include books, posters, brochures, photos, videos, educational slides, recollection of memories, problem-solving workshop, formation of virtual groups and membership of participants in social networking groups, the reflection of values, motivations, needs, and desires of participants about pregnancy and childbirth on a piece of paper and discussion, description and sharing participants' personal skills, and drawing participants pictures of their family (for identifying their role and support in the family). If possible, the educational intervention is held in 4 training sessions of at least 30 minutes in 4 groups of 6 people and 2 groups of 7 people, one day a week for each group at the Health Comprehensive Service Centers of Bostanabad city of East Azerbaijan by the researcher in face to face. A reminder text message is sent to participants about the time and place of the meeting before each meeting. All of the training sessions will be completed by the 16th- week gestation. The evaluation of the educational intervention will be done in two phases; immediately and 6 months after the end of the educational intervention. Participants will re-complete the initial assessment tool. After birth, the method of delivery and the reason for choosing are recorded.
Category
Behavior
2
Description
Control group: This group will receive routine pregnancy care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Comprehensive Service Centers
Full name of responsible person
Ramak Zavar Kaabeh
Street address
Bostanabad Health Network, Imam Khomeini Ave
City
Bostanabad
Province
East Azarbaijan
Postal code
5410177111
Phone
+98 41 4333 3238
Email
kanani.safieh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Yaghoub Fatolahi
Street address
Jalal AleAhmad Ave
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Email
Res@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Safieh Kananikandeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Valiasr Town
City
Bostanabad
Province
East Azarbaijan
Postal code
5497173579
Phone
+98 914 158 0645
Email
kanani.safieh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Safieh Kananikandeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Valiasr Town
City
Bostanabad
Province
East Azarbaijan
Postal code
5497173579
Phone
+98 914 158 0645
Email
kanani.safieh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Safieh Kananikandeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Valiasr Town
City
Bosatanabad
Province
East Azarbaijan
Postal code
5497173579
Phone
+98 914 158 0645
Email
kanani.safieh@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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The demographic characteristics of the participants are confidential, but information about other variables will be shared.
When the data will become available and for how long
Six months after the publication of the paper
To whom data/document is available
Researchers in scientific and academic institutions, Health Education and Health Promotion Unit of the Ministry of Health and Family Health Unit of the Ministry of Health
Under which criteria data/document could be used
Educational and research use is allowed with the permission of the ethics committee of the Tarbiat Modares University of Tehran.
The request should be made through the Vice Chancellor for Research of Medical Universities.
From where data/document is obtainable
Corresponding author - Dr. Farkhondeh Aminshokravi
aminsh_f@modares.ac.ir
What processes are involved for a request to access data/document
Up to one week receiving a request via email to the responsible study corresponding author