- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07453979
AI-Supported Video Education in Episiotomy Care
The Effect of an Artificial Intelligence-Assisted Video Education Program on Episiotomy Wound Healing, Pain, and Dyspareunia: A Randomized Controlled Trial"
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although the postpartum period is generally considered a positive experience for mothers, obstetric interventions such as episiotomy may lead to various health problems. Episiotomy, defined as a strategic surgical incision made in the perineum during the second stage of labor, remains a fundamental obstetric intervention (WHO, 2018). Despite the World Health Organization's recommendation to reduce episiotomy rates in normal vaginal births to 10%, this procedure is still performed in approximately 30-50% of women (WHO, 2018), and post-episiotomy perineal discomfort has been reported in 42% of women (Roma et al., 2023).
Episiotomy may result in bleeding, infection, and postpartum pain associated with an increased risk of dyspareunia, thereby negatively affecting women's quality of life and sexual health (Hartinah et al., 2021). Minimizing these adverse outcomes requires preventing chronic pain, supporting mothers in effective pain management, preventing constipation, monitoring urinary retention, and reducing the risk of infection (Hartinah et al., 2021).
Evidence indicates that keeping the episiotomy wound dry, compared with sitz baths, reduces postpartum pain, accelerates wound healing, and positively influences postpartum sexual function (Alirezaei et al., 2024; Roma et al., 2023; Brezeanu et al., 2025; Aydemir et al., 2024). Therefore, education on episiotomy wound care constitutes a critical component of postpartum care.
The aim of this study is to evaluate the effect of an artificial intelligence-supported video education on episiotomy wound healing and postpartum sexual quality of life. Additionally, the study seeks to determine the impact of AI-supported video education on episiotomy wound healing, pain, and dyspareunia among postpartum women and to provide a foundation for future research in this field.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
18 years of age and older,
- No high-risk pregnancy (no systemic disease, no smoking, no postpartum complications),
- Gestational age 37-42 weeks,
- Single vaginal delivery of live birth,
- Mediolateral episiotomy,
- Not taking any medication,
- No other lacerations besides episiotomy (anal sphincter injury, 3rd degree perineal laceration).
- Single vaginal delivery of live birth or single vaginal delivery without episiotomy, age between 18-35 years, sexually active and healthy
- Primiparous pregnant women
Exclusion Criteria:
• Mothers who have had multiple, stillbirth, or anomalous births,
- Mothers who refuse home visits will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: INTERVENTION 1
Women allocated to the intervention group will receive an AI-assisted video-based educational intervention on episiotomy care in addition to routine postpartum care.
|
Women in the intervention group will receive routine postpartum care and an AI-assisted educational video about effective breastfeeding within the first 30 minutes after birth.
The video includes information on the importance of early breastfeeding, correct breastfeeding positions, and techniques to increase milk production.
|
|
Other: Control
Routine postpartum care
|
Women in the control group will receive routine postpartum and episiotomy care provided by midwives before discharge, in accordance with standard hospital practices.
No additional educational or AI-assisted video intervention will be provided to this group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
(REEDA Scale)
Time Frame: Postpartum Day 1, Day 3, Day 5, Day 7, and Day 14
|
Episiotomy wound healing will be evaluated using the REEDA Scale, which assesses five components: redness, edema, ecchymosis, discharge, and approximation of wound edges.
|
Postpartum Day 1, Day 3, Day 5, Day 7, and Day 14
|
|
Episiotomy wound healing score (REEDA Scale)
Time Frame: Postpartum day 1, day 3, day 5, day 7, and day 14
|
Episiotomy wound healing will be assessed using the REEDA Scale, which evaluates five components: redness, edema, ecchymosis, discharge, and approximation of wound edges
|
Postpartum day 1, day 3, day 5, day 7, and day 14
|
|
Perineal pain intensity (Visual Analog Scale - VAS)
Time Frame: Postpartum day 1, day 3, day 5, day 7, and day 14
|
Perineal pain intensity will be measured using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain).
Participants will indicate their perceived pain intensity on the scale.
|
Postpartum day 1, day 3, day 5, day 7, and day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum sexual function and dyspareunia score (Carol Postpartum Sexual Function and Dyspareunia Scale)
Time Frame: Postpartum 3 months after resumption of vaginal intercourse
|
Postpartum sexual function and dyspareunia will be evaluated using the Carol Postpartum Sexual Function and Dyspareunia Scale, which assesses readiness for sexual activity, vulvar discomfort, pain during vaginal intercourse, and pain after intercourse
|
Postpartum 3 months after resumption of vaginal intercourse
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Kahramanmaraş Sütçü İmam Ünive
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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