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AnxietyVITALNCT07064213

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

A study testing Behavioral: Educational Video in people with Anxiety, run by Wolfson Medical Center at 1 site in Israel.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Anxiety
What is being tested?
Behavioral: Educational Video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteIsrael
Study dates
10 Jul 2025to 10 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hagit Eisenberg, MD contact

+972 52 3397843

hagiteisen@yahoo.com

Israel1 site
  • Wolfson Medical Center

    Tel Aviv, 6997107

    Hagit Eisenberg, MD, +972 52 3397843, hagiteisen@yahoo.com

    Ilia Kleiner, MD, +972-52-8305195, kleiner.ilia@gmail.com

Other trials in Israel

About this study

Official title: Effect of an Informative Video About Perineal Tears on Anxiety During Labor: A Randomized Controlled Trial

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.

Read the 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
Being tested
Behavioral: Educational Video
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
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral: Educational VideoBehavioural

    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 groups in NCT07064213
Study groupRoleWhat they receive
Video GroupExperimentalParticipants watch an educational video about perineal tears and episiotomy via QR code before active labor.
Receives: Behavioral: Behavioral: Educational Video
Control GroupNo interventionReceives standard care without video

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2-24 hours postpartum

Secondary outcomes (4)
  1. Satisfaction with video (intervention group only)

    Satisfaction with the educational video will be assessed in the intervention group only. Participants will complete a brief, structured questionnaire within 2 to 24 hours postpartum. The questionnaire includes items assessing perceived usefulness, clarity of information, emotional impact, and whether the video helped them feel more prepared for labor and perineal outcomes.

    Measured: 2-24 hours postpartum

  2. Rate of perineal tears

    Measured: During delivery

  3. Rate of episiotomy

    Measured: During delivery

  4. Rate of OASIS

    Measured: During delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2025
  2. Study start10 Jul 2025 (estimated)
  3. Primary completion10 Jul 2026 (estimated)
  4. Study completion10 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07064213
Sponsor's protocol ID
WOMC-0109-25
Acronym
VITAL
Status last verified
Jul 2025
First submitted
2 Jul 2025
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) to be shared will include STAI-S questionnaire scores at both time points, participant age, gestational age at delivery, mode of delivery, and perineal outcomes including episiotomy, perineal tear grade, and OASIS status. No personally identifiable information will be shared. Data will be available upon reasonable request to the principal investigator.

Publications

  • 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.

    PubMed 37674105
  • 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.

    PubMed 23057716
  • 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.

    PubMed 32861872

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral: Educational Video in people with Anxiety, run by Wolfson Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ilia Kleiner, MD (+972-52-8305195, kleiner.ilia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in maternal anxiety score (time frame: 2-24 hours postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07064213, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.

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