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

NCT ID: NCT07064213

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2026-07-10

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.

Detailed Description

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Video Group

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

Group Type: EXPERIMENTAL

Behavioral: Educational Video

Intervention Type: 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.

Control Group

Receives standard care without video

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wolfson Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

ilia kleiner

Specialist Obstetrician & Gynecologist; Director, Labor and Delivery Rooms and Maternity Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilia Kleiner, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfson Medical Center

Hagit Eisenberg, MD

Role: STUDY_DIRECTOR

Wolfson Medical Center

Julia Barda Fishler, MD

Role: STUDY_DIRECTOR

Wolfson Medical Center

Locations

Wolfson Medical Center

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Ilia Kleiner, MD

Role: CONTACT

kleiner.ilia@gmail.com

+972-52-8305195

Hagit Eisenberg, MD

Role: CONTACT

hagiteisen@yahoo.com

+972 52 3397843

Facility Contacts

Hagit Eisenberg, MD

Role: primary

hagiteisen@yahoo.com

+972 52 3397843

Ilia Kleiner, MD

Role: backup

kleiner.ilia@gmail.com

+972-52-8305195

References

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.

Reference Type: BACKGROUND

PMID: 37674105 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23057716 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32861872 (View on PubMed)

Other Identifiers

WOMC-0109-25

Identifier Type: -

Identifier Source: org_study_id