Simulation of Labor (SOL Study) (SOL)
Simulation of Labor : a Novel Strategy to Enhance Parental Awareness, Competence, and Positive Childbirth Experience Among Primiparous Women: a Randomized Controlled Trial (SOL Study)
Fear of childbirth and low childbirth self-efficacy are recognized factors associated with negative birth experiences, increased anxiety, reduced maternal satisfaction, and a greater likelihood of obstetric interventions. Although antenatal education programs are widely used to prepare expectant parents for childbirth, considerable variability exists in their content and delivery, and many programs provide limited preparation for the emotional, relational, and organizational challenges encountered during labor and birth.
This randomized controlled trial aims to evaluate the effectiveness of the Simulation of Labor (SOL) intervention, a personalized and experiential childbirth preparation program designed for primiparous women involving their birth partners. In addition to standard antenatal education, participants allocated to the intervention group will attend a structured labor simulation that reproduces labor and birth scenarios, hospital care processes, communication with healthcare professionals, non-pharmacological pain management strategies, and potential unexpected obstetric events. The simulation is tailored to participants' individual needs, concerns, and expectations identified before the intervention.
Participants in the control group will receive standard antenatal education alone. The primary objective is to determine whether the SOL intervention reduces fear of childbirth before birth compared with standard antenatal education. Secondary objectives include evaluating childbirth self-efficacy, childbirth attitudes, birth experience, maternal participation in decision-making, obstetric interventions, mode of birth, and selected maternal and neonatal outcomes.
The study will assess whether a personalized labor simulation can improve childbirth preparedness, strengthen parental competence and confidence, and promote a more positive and empowering birth experience.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Childbirth is a major life event that can have important psychological, emotional, and physical consequences for women and their families. Fear of childbirth and low childbirth self-efficacy have been associated with increased anxiety, poorer childbirth experiences, reduced maternal satisfaction, and a greater likelihood of obstetric interventions. Although antenatal education programs are widely offered to prepare expectant parents for labor and birth, substantial heterogeneity exists in their content, delivery methods, and effectiveness. Furthermore, many currently available programs provide limited preparation for real-life hospital dynamics, communication with healthcare professionals, management of unexpected clinical situations, and emotional responses during labor and birth.
Simulation-based education is an experiential learning strategy that has been shown to improve confidence, reduce anxiety, enhance decision-making skills, and strengthen preparedness in healthcare and educational settings. Preliminary studies investigating simulation-based childbirth education have reported promising effects on childbirth-related anxiety, fear of childbirth, and childbirth self-efficacy. However, the available interventions have generally been standardized rather than individualized, have provided limited involvement of birth partners, and have not fully reproduced the clinical, organizational, and emotional context in which childbirth occurs.
The Simulation of Labor (SOL) study was developed to address these gaps. The intervention consists of a personalized labor and birth simulation designed for primiparous women and their birth partners. Prior to the simulation, couples participate in a structured interview aimed at identifying individual concerns, expectations, specific fears, and positive emotional resources. Information collected during this interview is used to tailor the simulation experience to the needs of each couple.
The simulation reproduces labor and birth scenarios within a realistic hospital environment and includes hospital admission procedures, communication with healthcare professionals, non-pharmacological pain management techniques, emotional coping strategies, decision-making processes, and selected unexpected or adverse obstetric situations that may occur during childbirth. The intervention combines experiential learning, individualized preparation, active partner involvement, and exposure to realistic labor and hospital scenarios within a psychologically safe learning environment. A structured debriefing session follows the simulation to facilitate reflection and integration of the experience.
This prospective randomized controlled trial will compare standard antenatal education alone with standard antenatal education plus the SOL intervention. Following informed consent and completion of baseline assessments, eligible participants will be randomized in a 1:1 ratio to either the intervention or control group. To ensure balance with respect to the primary prognostic factor, randomization will be stratified according to baseline fear of childbirth measured using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A), with participants classified as having severe fear of childbirth (score ≥85) or non-severe fear of childbirth (score <85).
The primary objective of the study is to evaluate whether participation in the SOL intervention reduces fear of childbirth before birth compared with standard antenatal education alone. Secondary objectives include evaluating childbirth self-efficacy, childbirth attitudes, childbirth experience, maternal participation in decision-making, obstetric interventions, mode of birth, and selected maternal and neonatal outcomes. The study will assess whether a personalized labor simulation can improve childbirth preparedness, strengthen parental competence and confidence, and promote a more positive childbirth experience.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Alessia Selmin
- Telefonní číslo: +390498214434
- E-mail: alessia.selmin@unipd.it
Studijní záloha kontaktů
- Jméno: Honoria Ocagli, PhD
- E-mail: honoria.ocagli@ubep.unipd.it
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Pregnant women with singleton gestation
- Gestational age ≥ 37 weeks (term pregnancy)
- Cephalic fetal presentation
- Absence of contraindications to vaginal birth
- Primigravid women aged ≥ 20 years
- Direct admission to the labor ward or stay in the antenatal ward < 3 hours
- Stable and long-term couple relationship
- Italian-speaking couple
- Attendance of a childbirth preparation course offered by a public and/or private service (online or in person)
- Intention to give birth at the University Hospital of Padua
Exclusion Criteria:
- Pregnancies complicated by conditions that contraindicate vaginal birth
- Breech presentation
- Twin pregnancy
- Preterm labor (< 37 weeks)
- Fetal malformations or fetal distress
- Maternal conditions contraindicating vaginal birth
- Multiparous women or women aged < 20 years
- Prolonged stay in the antenatal ward (> 3 hours)
- Unstable or short-term couple relationship
- Significant psychiatric history or severe mental illness
- Substance use or dependence
- Refusal to provide informed consent
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Personalized Labor Simulation + Standard Antenatal Education
Participants assigned to the intervention group will receive a personalized labor simulation in addition to standard antenatal education. Before the intervention, all participants will complete baseline assessments evaluating fear of childbirth, childbirth attitudes, self-efficacy, pregnancy-related anxiety, general anxiety, personality traits, and preferred mode of birth. Randomization will be stratified according to baseline fear of childbirth measured with the Wijma Delivery Expectancy/Experience Questionnaire Version A (WDEQ-A; score ≥85 vs. <85). Following randomization, couples allocated to the intervention group will participate in a brief online interview (approximately 30 minutes) to identify individual fears, expectations, support needs, and positive emotional cues. This information will be used to tailor the simulation. The intervention consists of a structured, approximately 2-hour labor and birth simulation conducted in small groups (3-4 couples) with both partn |
The intervention consists of a structured, approximately 2-hour labor and birth simulation delivered in small groups of 3-4 couples, with both partners present. The simulation is personalized according to the specific fears, concerns, and needs identified by each couple. It recreates key stages of labor and birth, including hospital procedures, communication with healthcare professionals, non-pharmacological pain management strategies, emotional coping techniques, decision-making processes, and potential obstetric scenarios. A structured debriefing session follows the simulation to facilitate reflection, discussion, and emotional processing. |
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Aktivní komparátor: Standard Antenatal Education
Participants assigned to the control group will receive standard antenatal education according to their usual prenatal care pathway. No labor simulation will be provided. Participants will complete the same baseline, pre-birth, and postpartum assessments as the intervention group, including measures of childbirth fear, childbirth attitudes, self-efficacy, anxiety, and birth experience. Obstetric and neonatal outcomes will be collected from medical records. |
Participants will complete the same baseline, pre-birth, and postpartum assessments as the intervention group, including measures of childbirth fear, childbirth attitudes, self-efficacy, anxiety, and birth experience. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Between-group difference in change in childbirth fear score
Časové okno: Between enrolment (before simulation or standard antenatal education) and simulation or the completion of standard antenatal education within one week
|
Between-group difference in change in childbirth fear score, measured using the Wijma Delivery Expectancy/Experience Questionnaire A, from: Pre-intervention/baseline: assessment performed before the simulation for the intervention group and before completion of the standard childbirth preparation course for the control group. Post-intervention, before birth: assessment performed after the intervention (simulation) for the intervention group and after completion of the standard childbirth preparation course for the control group. Responses will be collected within 1 week after the intervention/course completion. |
Between enrolment (before simulation or standard antenatal education) and simulation or the completion of standard antenatal education within one week
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Between-group difference in perceived childbirth self-efficacy before birth.
Časové okno: Within one week after the simulation or the completion of standard antenatal education
|
Between-group difference in perceived childbirth self-efficacy before birth, assessed using the Childbirth Self-Efficacy Inventory. |
Within one week after the simulation or the completion of standard antenatal education
|
|
Between-group difference in childbirth attitude (preference)
Časové okno: Between enrolment (before simulation or standard antenatal education) and simulation or the completion of standard antenatal education within one week
|
Between-group difference in childbirth attitude (preference) before birth, assessed through preferred mode of delivery (vaginal delivery or cesarean section). |
Between enrolment (before simulation or standard antenatal education) and simulation or the completion of standard antenatal education within one week
|
|
Between-group difference in change in childbirth fear score, measured using the Childbirth Attitude Questionnaire
Časové okno: Between enrolment (before simulation or standard antenatal education) and simulation or the completion of standard antenatal education within one week
|
Between-group difference in change in childbirth fear score, measured using the Childbirth Attitude Questionnaire pre-intervention and post intervention (before birth) |
Between enrolment (before simulation or standard antenatal education) and simulation or the completion of standard antenatal education within one week
|
|
Between-group difference in childbirth fear after delivery, measured using the Wijma Delivery Expectancy/Experience Questionnaire B
Časové okno: Within one week after delivery
|
Between-group difference in childbirth fear after delivery, measured using the Wijma Delivery Expectancy/Experience Questionnaire B at postpartum assessment. |
Within one week after delivery
|
|
Within-group change in childbirth fear scores in the intervention group before and after the intervention, measured using the Wijma Delivery Expectancy/Experience Questionnaire A
Časové okno: Between enrolment (before simulation) and simulation within one week after the completion
|
Within-group change in childbirth fear scores in the intervention group before and after the intervention, measured using the Wijma Delivery Expectancy/Experience Questionnaire A, assessed before simulation or standard antenatal educatione and after simulation or standard antenatal education |
Between enrolment (before simulation) and simulation within one week after the completion
|
|
Difference in the duration of labor stages between groups
Časové okno: Within one week after delivery
|
Difference in the duration of labor stages between groups (in minutes) extracted from clinical records. |
Within one week after delivery
|
|
Between-group difference in the use of medical procedures to accelerate labor
Časové okno: Within one week after delivery
|
Between-group difference in the use of medical procedures to accelerate labor, such as amniotomy or oxytocin administration (from clinical records). |
Within one week after delivery
|
|
Difference in mode of delivery between groups
Časové okno: Within one week after delivery
|
Difference in mode of delivery between groups (vaginal birth vs cesarean or operative delivery) assessed using clinical records |
Within one week after delivery
|
|
Difference in neonatal Apgar scores between groups.
Časové okno: Within one week after delivery
|
Difference in neonatal Apgar scores (at fist minute expressed from 1 to 10/10) between groups assessed using clinical records. |
Within one week after delivery
|
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Difference in active participation and negotiation ability of the woman/couple (subjective outcome)
Časové okno: Within one week after delivery
|
Difference in active participation and negotiation ability of the woman/couple, assessed through postpartum narrative interviews (birth narratives), in particular regarding the autonomous use of non-pharmacological pain-management strategies during labor (vocalizations, visualizations, warm water, emotional anchoring, acupressure, movement and position changes, music, dim lighting, and behaviors promoting hormonal regulation), negotiation and clarification regarding invasive procedures, and overall perception of a positive and satisfying birth experience. |
Within one week after delivery
|
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Perceived effectiveness of simulation versus traditional childbirth class
Časové okno: Within one week after delivery
|
Perceived effectiveness of simulation versus traditional childbirth class (10-point Likert scale), assessed through a postpartum questionnaire in both groups, including: reduction of disorientation during labor, increased partner activation and involvement, clearer understanding of professional care and obstetric procedures, reduced perception of partner uselessness during labor, and increased maternal sense of empowerment in managing childbirth. |
Within one week after delivery
|
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Within-group change in childbirth fear scores in the intervention group before and after the intervention, measured using the Childbirth Attitude Questionnaire
Časové okno: Between enrolment (before simulation) and simulation within one week after the completion
|
Within-group change in childbirth fear scores in the intervention group before and after the intervention, measured using the Childbirth Attitude Questionnaire, assessed before simulation and after simulation |
Between enrolment (before simulation) and simulation within one week after the completion
|
Spolupracovníci a vyšetřovatelé
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Spolupracovníci
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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- SOL
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