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Clinical Trials in Israel / NCT07064213
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An Informative Video About Perineal Tears During Labor for Anxiety Reduction: A Randomized Controlled Trial

NCT07064213 · tracked via the Priya Life Science Israel tracker
Phase
Not applicable
Started
2025-07-10
Last updated
2025-07-14

Condition(s) studied

Anxiety

Investigational drug(s) / intervention(s)

Behavioral: Educational Video

Behavioral: Educational Video: Participants will watch a 2-minute educational video in Hebrew about perineal tears and episiotomy. The video includes information about types and grades of tears, risk factors, prevention strategies, episiotomy use, healing process, and when to seek help. The video is presented on a secure mobile device by the research team before the onset of active labor.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion: Primiparous women Age ≥18 Gestational age ≥37 weeks Fluent in Hebrew (able to complete STAI-S) Exclusion: IUFD Pregnancy termination Diagnosis of anxiety disorder Language barrier (cannot complete STAI-S)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Wolfson Medical Center Tel Aviv Israel

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07064213 on ClinicalTrials.gov ↗ ← All trials in Israel