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

NCT07064213 | Not Yet Recruiting

• 1 other identifier: WOMC-0109-25
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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

Anxiety

Keywords

Perineal Tears; Childbirth Education; Primiparous Women; Labor and Delivery; Childbirth-Related Anxiety; Intrapartum Anxiety; Obstetric trauma; Episiotomy; Vaginal delivery; OASIS; STAI-S; Maternal mental health

Outcome Measures

Primary Outcomes (1)

• Change in maternal anxiety score

  The primary outcome is the change in maternal anxiety as measured by the State-Trait Anxiety Inventory - State version (STAI-S). This validated questionnaire includes 20 items that assess situational anxiety on a 4-point scale, with total scores ranging from 20 to 80. Higher scores indicate greater anxiety. The STAI-S will be administered at two time points: (1) upon enrollment, before the active phase of labor begins, and (2) 2 to 24 hours after delivery. The difference in scores between these two time points will be compared between the intervention and control groups to assess whether viewing a short, informative video about perineal tears reduces anxiety during labor.

  2-24 hours postpartum

Secondary Outcomes (4)

• Satisfaction with video (intervention group only)

  2-24 hours postpartum

• Rate of perineal tears

  During delivery

• Rate of episiotomy

  During delivery

• Rate of OASIS

  During delivery

Study Arms (2)

Video Group

EXPERIMENTAL

Participants watch an educational video about perineal tears and episiotomy via QR code before active labor.

Behavioral: Behavioral: Educational Video

Control Group

NO INTERVENTION

Receives standard care without video

Interventions

Behavioral: Educational Video BEHAVIORAL

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.

Video Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Self-identified women who are pregnant and meet inclusion criteria for labor participation.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous women
• Age ≥18
• Gestational age ≥37 weeks
• Fluent in Hebrew (able to complete STAI-S)

You may not qualify if:

• IUFD
• Pregnancy termination
• Diagnosis of anxiety disorder
• Language barrier (cannot complete STAI-S)

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson Medical Center

Tel Aviv, 6997107, Israel

Location

Related Publications (3)

• Opondo C, Harrison S, Sanders J, Quigley MA, Alderdice F. The relationship between perineal trauma and postpartum psychological outcomes: a secondary analysis of a population-based survey. BMC Pregnancy Childbirth. 2023 Sep 6;23(1):639. doi: 10.1186/s12884-023-05950-6.

  PMID: 37674105 BACKGROUND

• Priddis H, Dahlen H, Schmied V. Women's experiences following severe perineal trauma: a meta-ethnographic synthesis. J Adv Nurs. 2013 Apr;69(4):748-59. doi: 10.1111/jan.12005. Epub 2012 Oct 12.

  PMID: 23057716 BACKGROUND

• Darmody E, Bradshaw C, Atkinson S Dr. Women's experience of obstetric anal sphincter injury following childbirth: An integrated review. Midwifery. 2020 Dec;91:102820. doi: 10.1016/j.midw.2020.102820. Epub 2020 Aug 22.

  PMID: 32861872 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Ilia Kleiner, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

• Hagit Eisenberg, MD

  Wolfson Medical Center

  STUDY DIRECTOR

• Julia Barda Fishler, MD

  Wolfson Medical Center

  STUDY DIRECTOR

Central Study Contacts

Ilia Kleiner, MD

CONTACT

+972-52-8305195; kleiner.ilia@gmail.com

Hagit Eisenberg, MD

CONTACT

+972 52 3397843; hagiteisen@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Obstetrician & Gynecologist; Director, Labor and Delivery Rooms and Maternity Department

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 10, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months after study completion and available for 2 years.
• Access Criteria: De-identified individual participant data and supporting documents (study protocol, SAP, and informed consent form) will be made available to qualified researchers with institutional ethics approval. Access will be granted upon submission and approval of a methodologically sound proposal. Requests should be sent to the principal investigator via email. Approved data will be shared electronically in a secure, password-protected format.

Locations

IL (1)