Postpartum Perineal PainNCT07453979
AI-Supported Video Education in Episiotomy Care
A study testing AI-Assisted Episiotomy Care Video Group in people with Postpartum Perineal Pain, run by Burdur Mehmet Akif Ersoy University.
Trial summary
Although the postpartum period is generally considered a positive experience, obstetric interventions such as episiotomy may lead to significant maternal health problems. Episiotomy, a surgical incision performed on the perineum during the second stage of labor, remains widely used despite World Health Organization… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Perineal Pain
- What is being tested?
- AI-Assisted Episiotomy Care Video Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2026to 30 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
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- 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
Who cannot join
- • Mothers who have had multiple, stillbirth, or anomalous births,
- Mothers who refuse home visits will be excluded.
About this study
Official title: The Effect of an Artificial Intelligence-Assisted Video Education Program on Episiotomy Wound Healing, Pain, and Dyspareunia: A Randomized Controlled Trial"
Although the postpartum period is generally considered a positive experience, obstetric interventions such as episiotomy may lead to significant maternal health problems. Episiotomy, a surgical incision performed on the perineum during the second stage of labor, remains widely used despite World Health Organization recommendations to limit its rate. Episiotomy-related complications, including pain, infection, bleeding, and dyspareunia, can negatively affect wound healing, quality of life, and postpartum sexual health. Proper episiotomy wound care and education are therefore essential components of postpartum care. This study aims to evaluate the effect of an artificial intelligence-supported video education on episiotomy wound healing and postpartum sexual quality of life. The findings are expected to contribute to improved postpartum care practices and guide future research in this field.
Read the 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.
- Conditions
- Postpartum Perineal Pain
- Being tested
- Control, AI-Assisted Episiotomy Care Video Group
- Keywords
- Episiotomy, Postpartum Care, Artificial Intelligence, Wound Healing, Sexual Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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.
AI-Assisted Episiotomy Care Video GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION 1 | Experimental | Women allocated to the intervention group will receive an AI-assisted video-based educational intervention on episiotomy care in addition to routine postpartum care. Receives: Behavioral: AI-Assisted Episiotomy Care Video Group |
| Control | Other | Routine postpartum care Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
(REEDA Scale)
Episiotomy wound healing will be evaluated using the REEDA Scale, which assesses five components: redness, edema, ecchymosis, discharge, and approximation of wound edges.
Measured: Postpartum Day 1, Day 3, Day 5, Day 7, and Day 14
Episiotomy wound healing score (REEDA Scale)
Episiotomy wound healing will be assessed using the REEDA Scale, which evaluates five components: redness, edema, ecchymosis, discharge, and approximation of wound edges
Measured: Postpartum day 1, day 3, day 5, day 7, and day 14
Perineal pain intensity (Visual Analog Scale - VAS)
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.
Measured: Postpartum day 1, day 3, day 5, day 7, and day 14
Secondary outcomes (1)
Postpartum sexual function and dyspareunia score (Carol Postpartum Sexual Function and Dyspareunia Scale)
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
Measured: Postpartum 3 months after resumption of vaginal intercourse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start2 Apr 2026 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum Perineal PainStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Gokduman Keles, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453979
- Sponsor's protocol ID
- Kahramanmaraş Sütçü İmam Ünive
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Artificial Intelligence-Assisted Video Education Program on Episiotomy Wound Healing, Pain, and Dyspareunia: A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07453979
- Acronym / sponsor ID
- Kahramanmaraş Sütçü İmam Ünive
- Conditions
- Postpartum Perineal Pain
- Keywords
- Episiotomy, Postpartum Care, Artificial Intelligence, Wound Healing, Sexual Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 6 Mar 2026 (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.
Although the postpartum period is generally considered a positive experience, obstetric interventions such as episiotomy may lead to significant maternal health problems. Episiotomy, a surgical incision performed on the perineum during the second stage of labor, remains widely used despite World Health Organization recommendations to limit its rate. Episiotomy-related complications, including pain, infection, bleeding, and dyspareunia, can negatively affect wound healing, quality of life, and postpartum sexual health. Proper episiotomy wound care and education are therefore essential components of postpartum care. This study aims to evaluate the effect of an artificial intelligence-supported video education on episiotomy wound healing and postpartum sexual quality of life. The findings are expected to contribute to improved postpartum care practices and guide future research in this field.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION 1 | Experimental | Behavioral: AI-Assisted Episiotomy Care Video GroupWomen allocated to the intervention group will receive an AI-assisted video-based educational intervention on episiotomy care in addition to routine postpartum care. |
| Control | Other | Other: ControlRoutine postpartum care |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (2 listed)
- • Mothers who have had multiple, stillbirth, or anomalous births,
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 |
|---|---|---|
| ControlWomen 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. | Other | Control |
| AI-Assisted Episiotomy Care Video GroupWomen 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. | Behavioural | INTERVENTION 1 |
Primary outcome
(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.
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
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.
1 secondary outcome
Postpartum sexual function and dyspareunia score (Carol Postpartum Sexual Function and Dyspareunia Scale)
Time frame: Postpartum 3 months after resumption of vaginal intercourse
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 6 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Assisted Episiotomy Care Video Group in people with Postpartum Perineal Pain, run by Burdur Mehmet Akif Ersoy University.
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 9 inclusion and 2 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(REEDA Scale) (time frame: Postpartum Day 1, Day 3, Day 5, Day 7, and Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2026.