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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
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 group | Role | What they receive |
|---|---|---|
| Video Group | Experimental | Participants watch an educational video about perineal tears and episiotomy via QR code before active labor. Receives: Behavioral: Behavioral: Educational Video |
| Control Group | No intervention | Receives standard care without video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Rate of perineal tears
Measured: During delivery
Rate of episiotomy
Measured: During delivery
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.
- First posted14 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ilia kleiner, Wolfson Medical Center
- Investigators
- Ilia Kleiner, MD, Principal investigator, Wolfson Medical CenterHagit Eisenberg, MD, Study director, Wolfson Medical CenterJulia Barda Fishler, MD, Study director, Wolfson Medical Center
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 37674105Priddis 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 23057716Darmody 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Informative Video About Perineal Tears on Anxiety During Labor: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07064213
- Acronym / sponsor ID
- VITAL / WOMC-0109-25
- Conditions
- Anxiety
- Keywords
- Perineal Tears, Childbirth Education, Primiparous Women, Labor and Delivery, Childbirth-Related Anxiety, Intrapartum Anxiety, Obstetric trauma, Episiotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Group | Experimental | Behavioral: Behavioral: Educational VideoParticipants watch an educational video about perineal tears and episiotomy via QR code before active labor. |
| Control Group | No intervention | –Receives standard care without video |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primiparous women
- Age ≥18
- Gestational age ≥37 weeks
- Fluent in Hebrew (able to complete STAI-S)
Key exclusion criteria (4 listed)
- IUFD
- Pregnancy termination
- Diagnosis of anxiety disorder
- Language barrier (cannot complete STAI-S)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Educational VideoParticipants 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. | Behavioural | Video Group |
Primary outcome
Change in maternal anxiety score
Time frame: 2-24 hours postpartum
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.
4 secondary outcomes
Satisfaction with video (intervention group only)
Time frame: 2-24 hours postpartum
Rate of perineal tears
Time frame: During delivery
Rate of episiotomy
Time frame: During delivery
Rate of OASIS
Time frame: During delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Background: PubMed 37674105Opondo 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.
- Background: PubMed 23057716Priddis 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.
- Background: PubMed 32861872Darmody 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilia Kleiner, MD principal investigator
Wolfson Medical Center
Hagit Eisenberg, MD study director
Wolfson Medical Center
Julia Barda Fishler, MD study director
Wolfson Medical Center
1 site in 1 country: see every site and its status.
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.