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

NCT07064213 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-07-14

No results posted yet for this 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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Wolfson Medical Center

    lead OTHER_GOV

Principal Investigators

  • Ilia Kleiner, MD · Wolfson Medical Center

  • Hagit Eisenberg, MD · Wolfson Medical Center

  • Julia Barda Fishler, MD · Wolfson Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2026-07-10
Completion
2026-07-10

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07064213 on ClinicalTrials.gov