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临床试验/NCT05358236
NCT05358236已完成不适用

The Effect of Episiotomy Wound Care and Genital Hygiene Training on Episiotomy Wound Healing and Pain Perception: Randomized Controlled Trial

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
2
主要终点
Episiotomy Area Evaluation before intervention

研究概览

简要总结

The World Health Organization (WHO) and professional societies recommend restricted episiotomy instead of routine episiotomy. However, since the 1990s, there has been evidence of the risks of the procedure, and although routine use has no benefit, it is still widely used. In this study, investigators aimed to determine the effect of episiotomy on the wound healing process and pain perception by providing episiotomy wound healing and genital hygiene training with training material created to raise awareness about wound care after episiotomy and to eliminate factors that delay the healing of episiotomy wound.

详细描述

This study aimed to determine the effect of episiotomy wound care and genital hygiene training on episiotomy wound healing and pain perception.

Methods: In this study, investigators used a randomized controlled trial approach.

It was carried out in the postpartum service of the medical faculty hospital. 128 participants who underlap vaginal postpartum episiotomy were randomly assigned to the experimental and control group. The women who gave birth in the experimental group were given episiotomy wound care and genital hygiene training. The routine postpartum care was given to the participants who gave birth in the control group. The data were collected using the personal information form, the episiotomy area evaluation scale (REEDA score), and the Visual Analog Scale (VAS).

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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
Double (Investigator, Outcomes Assessor)

盲法说明

No intervention will be made by the responsible researcher. Thus, she will be blinded to the experimental and control groups. The training intervention and data collection process will be carried out by the co-researcher. It will also enter the data into the SPSS program as A and B groups. The analysis will be carried out by the researcher blinded to the groups. After the reporting process is completed, it will be announced to which groups A and B groups belong. Participants will also be blind to each other.

入排标准

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

入选标准

  • 18 years of age and older
  • primiparous
  • givingbirth vaginally on due date (37-42 gestational weeks)
  • who have a healthy newborn,
  • who have a mediolateral episiotomy,
  • who do not have communication problems
  • who can understand and speak Turkish were included in the research.

排除标准

  • Givingbirth by cesarean section
  • Having third and fourth-degree perineal tears,
  • Having a history of diseases that prevent wound healing,
  • Using certain drugs (eg, glucocorticoids, anticoagulants, chemotherapy, immunosuppressant, and radiotherapy),
  • Having chronic systemic diseases (heart, kidney and lung diseases, coagulation disorder, immunodeficiency, connective tissue disorders, and diabetes),
  • Having history of genital warts, symptomatic vaginitis,
  • Having history of perineal reconstructive surgery, any postpartum complication (hemorrhage, puerperal infection, mastitis, thromboembolic disease or postpartum psychiatric disorder)

结局指标

主要结局

Episiotomy Area Evaluation before intervention

时间窗: postpartum 1sth day (after birth first 24 hours)

Assessed using the Episiotomy Area Evaluation Scale (REEDA SCORE) before intervention. This scale covers five factors indicating perineal wound healing: (1) Redness, (2) Edema, (3) Ecchymosis, (4) Discharge, and (5) Approximation. A total REEDA score is obtained by evaluating each category of these five recovery factors. The scale is evaluated by giving 0, 1, 2, and 3 points to each evaluation. The lowest score is 0 and the highest score is 15.

Personal information form before intervention

时间窗: postpartum 1sth day (after birth first 24 hours)

Assessed using personal information. This instrument contains questions on women's sociodemographic and postpartum.

Episiotomy pain Evaluation before intervention

时间窗: postpartum 1sth day (after birth first 24 hours)

The Visual Analogue Scale (VAS) scale, which would be applied to evaluate episiotomy pain in the postpartum period, was used to convert some values that cannot be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line. The participant was asked to indicate where his or her condition is suitable on this line by drawing a line or by placing a dot or pointing. "No pain" is written on one end and "very severe pain" on the opposite end; the participant was asked to mark the pain condition on this line.was used to convert some values that could not be measured numerically, and two-end definitions of the parameter to be evaluated are written at both ends of a 100 mm line.

次要结局

  • Episiotomy Area Evaluation after intervention(Postpartum 15th day)
  • Episiotomy pain Evaluation after intervention(Postpartum 15th day)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gonca Buran

Principal Investigator

Aydin Adnan Menderes University

研究点 (2)

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