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临床试验/NCT06325176
NCT06325176已完成不适用

Comparative Effects of Cryotherapy and Infrared Light on Pain, Redness and Healing of Episiotomy Wound

Riphah International University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
The standardized REEDA scale:

研究概览

简要总结

The study will be a randomized clinical trial and will be conducted in Bahawalpur Victoria Hospital, Bahawalpur. The subjects (n=24) will be divided into two groups. Group A will include 12 postnatal women and for treatment, cryotherapy will be applied for 20 minutes. Group B will include 12 women and receive infrared light, an infrared lamp will be put at a distance of 45 cm from the perineum, and the heat produced with 230 volts for twenty minutes. The participant will be checked after the first five minutes to make sure that she is not being burned. This procedure will be done twice a day for 7 consecutive days.

详细描述

One of the most often used delivery methods is the episiotomy. Severe side effects like infection, dehiscence of the incision, and perineal discomfort are possible. In addition to increased blood loss during birth, mothers who undergo episiotomy have the risk of experiencing delayed wound healing along with increased pain in the early puerperium. After birth, episiotomy treatment begins right away and would involve both pain management and local wound care. The data will be assessed on the baseline 3rd day and 7th day of treatment. A numeric pain rating scale (NPRS) will be used to assess the severity of Pain. REEDA scale will be used for Redness, Edema, Ecchymosis, Discharge, and Approximation (closeness of skin edges). SPSS version 25 will be used for analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Women who underwent episiotomy between 6 to 24 hours postpartum.
  • Delivered a live baby.
  • Complete full-term labor.
  • episiotomy type medial and Medio-lateral.
  • primiparous women and multiparous women.

排除标准

  • Used pain-relieving drugs.
  • Women with diabetes and pre-eclampsia.
  • Febrile conditions.
  • Severe infection.
  • Chronic medical conditions that may affect wound healing.
  • Allergies and sensitivity to heat/cold.
  • Recent surgery of pelvis or abdomen.

结局指标

主要结局

The standardized REEDA scale:

时间窗: up to 1 week

The REEDA scale is an observational check list used for assessing perineal healing.The acronym REEDA is derived from five components: Redness, Edema, Ecchymosis, Discharge and Approximation of the wound edges.Each component takes a score ranged from 0 to 3. Higher score indicates poor wound healing while lower score indicates good wound healing.The total score of REEDA scale was categorized as follows: 0 to 2 - Healed.3 to 5 - Moderately healed.6 to 8- Mildly healed.9 to 15 - Not healed.

Numeric Pain Rating Scale

时间窗: up to 1 week

The NPRS is a segmented numeric scale in which the respondent selects a whole number(0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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