Protocol summary
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Study aim
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Design, implementation, and evaluation of educational program based on salutogenesis theory on fear of childbirth and choice of delivery method among nulliparous women
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Fear of childbirth and vaginal delivery choice
General information
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Reason for update
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The fourth letter (u) of the Latin word salutogenesis was omitted.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210506051202N1
Registration date:
2021-08-21, 1400/05/30
Registration timing:
prospective
Last update:
2025-04-28, 1404/02/08
Update count:
2
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Registration date
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2021-08-21, 1400/05/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-09-23, 1401/07/01
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Expected recruitment end date
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2023-03-21, 1402/01/01
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Actual recruitment start date
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2022-11-01, 1401/08/10
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Actual recruitment end date
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2023-07-01, 1402/04/10
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Trial completion date
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empty
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Scientific title
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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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Public title
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Saltuogenesis theory on fear of childbirth
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
76
Actual sample size reached:
63
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-26, 1400/04/05
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Ethics committee reference number
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IR.MODARES.REC.1400.097
Health conditions studied
1
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Description of health condition studied
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Fear of childbirth
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ICD-10 code
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F40
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ICD-10 code description
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Phobic anxiety disorders
Primary outcomes
1
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Description
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Reduce fear of childbirth
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Timepoint
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Before the intervention, immediately after the intervention and 6 months after the intervention
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Method of measurement
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Wijma Delivery Expectancy/Experience Questionnaire- A
2
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Description
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Choice of natural childbirth
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Timepoint
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Before the intervention, immediately after the intervention and 6 months after the intervention
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Method of measurement
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Checklist for choosing the delivery method
Secondary outcomes
1
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Description
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Sense of coherence
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Timepoint
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Before the intervention, immediately after the intervention and 6 months after the intervention
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Method of measurement
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Antonovsky Coherence Scale (SOC-13)
Intervention groups
1
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Description
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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.
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Category
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Behavior
2
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Description
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Control group: This group will receive routine pregnancy care.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tarbiat Modares University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The demographic characteristics of the participants are confidential, but information about other variables will be shared.
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When the data will become available and for how long
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Six months after the publication of the paper
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To whom data/document is available
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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
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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Corresponding author - Dr. Farkhondeh Aminshokravi
aminsh_f@modares.ac.ir
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What processes are involved for a request to access data/document
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Up to one week receiving a request via email to the responsible study corresponding author
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Comments
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