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临床试验/NCT07453979
NCT07453979尚未招募不适用

The Effect of an Artificial Intelligence-Assisted Video Education Program on Episiotomy Wound Healing, Pain, and Dyspareunia: A Randomized Controlled Trial"

Burdur Mehmet Akif Ersoy University0 个研究点目标入组 70 人开始时间: 2026年4月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
主要终点
(REEDA Scale)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • • Mothers who have had multiple, stillbirth, or anomalous births,
  • Mothers who refuse home visits will be excluded.

研究组 & 干预措施

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.

干预措施: AI-Assisted Episiotomy Care Video Group (Behavioral)

Control

Other

Routine postpartum care

干预措施: Control (Other)

结局指标

主要结局

(REEDA Scale)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • Postpartum sexual function and dyspareunia score (Carol Postpartum Sexual Function and Dyspareunia Scale)(Postpartum 3 months after resumption of vaginal intercourse)

研究者

发起方
Burdur Mehmet Akif Ersoy University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mine Gokduman Keles

assistant Prof dr

Kahramanmaras Sutcu Imam University

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