Clinical Trial

An Informative Video About Perineal Tears During Labor for Anxiety Reduction: A Randomized Controlled Trial

Study acronym: VITAL
Not Yet Recruiting
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Record status
This record was last updated July 14, 2025 (before its estimated July 10, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study evaluates the impact of an informative video about perineal tears on maternal anxiety during labor. Perineal trauma during childbirth, especially severe tears such as obstetric anal sphincter injuries (OASIS), is associated with significant physical and psychological consequences, including anxiety, shame, fear, and social isolation. Despite growing awareness, many women report inadequate knowledge and preparation regarding these outcomes before labor. This prospective, single-center, randomized controlled trial will be conducted at Edith Wolfson Medical Center in Holon, Israel. A total of 110 primiparous women admitted for induction or early labor will be recruited prior to the active phase of labor. Participants will be randomized into two groups in a 1:1 ratio. The intervention group will watch a 2-minute educational video explaining the types, implications, and prevention strategies related to perineal tears. The control group will receive standard care without video exposure. The primary objective is to assess change in maternal anxiety using the validated State-Trait Anxiety Inventory (STAI-S) questionnaire, measured at baseline and 2-24 hours postpartum. Secondary outcomes include satisfaction with the video (in the intervention group), rates of perineal tears, episiotomy, and OASIS. Data will be collected from the hospital's EMR system and patient-reported questionnaires, stored securely and coded. The study aims to determine whether increasing knowledge through a short educational intervention can reduce childbirth-related anxiety and improve the birth experience.
Trial Details
NCT Number NCT07064213
Lead Sponsor Wolfson Medical Center
Conditions Anxiety
Enrollment 110 participants
Start Date 2025-07-10
Primary Completion 2026-07-10 (estimated)
Study Completion 2026-07-10 (estimated)
Updated on ClinicalTrials.gov 2025-07-14