Background and Rationale:
Perineal tears during vaginal delivery are a common obstetric complication, affecting both the physical and emotional well-being of mothers. Numerous studies have highlighted the psychological burden associated with severe tears, including obstetric anal sphincter injuries (OASIS). These can result in postpartum depression, posttraumatic stress symptoms (PTS), anxiety, and disruption to intimate and social relationships.
A comprehensive review by Darmody et al. (2020) and qualitative synthesis by Priddis et al. (2013) have shown that women experiencing significant perineal trauma may report feelings of shame, loneliness, failure, and fear, often amplified by insufficient understanding or preparation before delivery. More recent studies (Opondo et al., 2023; Baumann et al., 2024) found that the severity of tears correlates with psychological morbidity postpartum, including childbirth-related PTSD.
These findings underscore the importance of providing accessible, accurate information to women before delivery to empower them, reduce fear, and foster realistic expectations. However, no randomized controlled trial has yet evaluated whether a brief, targeted educational intervention specifically about perineal tears can reduce anxiety when given just before the active phase of labor.
Study Objective:
To evaluate whether viewing a short, informative video about perineal tears before the onset of active labor reduces maternal anxiety.
Study Design:
This is a prospective, randomized controlled trial (RCT) with two parallel arms. The study will be conducted at Edith Wolfson Medical Center, Holon, Israel, over a 12-month period. A total of 110 primiparous women ≥18 years old at ≥37 weeks gestation will be recruited from the Maternal-Fetal Medicine Unit or Delivery Room prior to active labor.
Eligibility Criteria:
Inclusion:
Primiparous women
Age 18-45
Gestational age ≥37 weeks
Fluent in Hebrew (able to complete STAI-S questionnaire)
Exclusion:
Intrauterine fetal death
Termination of pregnancy
Known anxiety disorder
Language barrier
Cesarean section during labor
Withdrawal of consent
Randomization:
Participants will be randomly assigned (1:1) to the intervention or control group. Randomization will be done using computerized block randomization by the study team.
Intervention:
The intervention group will watch a 2-minute educational video (in Hebrew) produced by the research team. The video provides information on types and degrees of perineal tears, the role of episiotomy, possible symptoms, healing, and preventative techniques. Viewing will take place using the researchers' secure mobile device.
The control group will receive routine intrapartum care with no additional information.
Outcomes:
Primary Outcome:
Change in STAI-S anxiety score from before active labor to 2-24 hours postpartum
Secondary Outcomes:
Satisfaction with the video (intervention group only)
Rate of perineal tears (any grade)
Rate of episiotomy
Rate of obstetric anal sphincter injuries (OASIS)
Data Collection and Analysis:
Anxiety will be assessed using the validated Hebrew version of the STAI-S questionnaire at two time points:
At enrollment, before active labor
2-24 hours after delivery
Demographic, clinical, and birth data will be extracted from the Chameleon hospital EMR system. Data will include: age, BMI, parity, pregnancy complications, labor duration, birthweight, Apgar scores, pH umbilical, and neonatal unit admission. All data will be anonymized and stored on password-protected hospital systems.
Statistical analysis will use SPSS v30. Continuous variables will be compared using t-tests, categorical variables with chi-square tests. p \< 0.05 will be considered statistically significant.
Sample Size Justification:
A pilot evaluation of 10 women showed mean STAI-S scores of 41 (SD = 11). Assuming a 15% reduction in anxiety in the intervention group, with α=0.05 and 80% power, 100 participants are required. Accounting for 10% loss to follow-up, the final sample is 110 (55 per arm).
Ethics and Privacy:
All participants will provide informed consent before enrollment. Data will be stored in coded form, with no personal identifiers. Participants may withdraw at any point. Ethics approval is/will be granted by the Wolfson Medical Center Helsinki Committee.
The study is expected to contribute valuable data on whether a low-cost, scalable educational tool can reduce childbirth anxiety and improve maternal emotional outcomes.
