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临床试验/NCT04512664
NCT04512664已完成不适用

Principal Investigator

University of Beykent0 个研究点目标入组 60 人开始时间: 2015年1月5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
60
主要终点
Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 1st hour

研究概览

简要总结

The aim of this study is to investigate the effects of different cold application times with cold gel pads after rhinoplasty on eyelid edema, eye ecchymosis and pain. A total of 60 patients undergoing rhinoplasty were divided into two groups by simple randomization method. Cold application applied to short term group for 4 hours and to long term group for 48 hours. Cold application was applied around both eyes with cold gel pads for 20 minutes per hour. Pain was evaluated with the Visuel Analog Scale, ecchymosis with eyelid ecchymosis score, and edema with eye-edema score. Edema and ecchymosis were evaluated on the 1st and 4th hours and 2nd day. Pain conditions were evaluated before and after analgesics for 1, 4 hours and 2 times daily.

详细描述

The research was carried out between January 2015 and March 2017 in an education and research hospital with a capacity of 26 beds. The research was suspended between July 2015 and January 2016. Patients who underwent rhinoplasty / septorhinoplasty operation between January 2015 and March 2017 with open or closed technique were included in the study. The study included patients who were 18 years of age or older who underwent a rhinoplasty / septorhinoplasty operation voluntarily. Patients who had cold allergy, refused to participate, applied outside of the research protocol and required re-operation in the early postoperative period due to complications were excluded from the study. All patients were provided with training and brochures for preoperative, intraoperative and postoperative periods. The cold application was done with gel pads of the same size and weight (13 cm x 13 cm-approximately 100 g) for 20 minutes per hour. Cold application was performed by the researcher in both groups for the first 4 hours. The patients in the short-term cold application group were given cold application by the researcher for 4 hours and 20 minutes per hour and the cold application was terminated. In the long-term application group, the first 4 hours of cold application were done by the researcher. Cold application after 4 hours; jel pads was applied at home by the patient's relative in accordance with the training given on the cold application protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • aged 18 years or older
  • who underwent rhinoplasty / septorhinoplasty
  • voluntarily participated in the study

排除标准

  • Patients with cold allergy,
  • refused to participate,
  • performed outside the research protocol,
  • required early re-operation due to postoperative complications

结局指标

主要结局

Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 1st hour

时间窗: Postoperative 1st hour

Bruising around the eye

Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 4th hour

时间窗: Postoperative 4th hour

Bruising around the eye

Echymosis around the eye as assessed using 4-point Eyelid ecchmosis scale: Postoperative 2nd day

时间窗: Postoperative 2nd day

Bruising around the eye

次要结局

  • Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 4th hour(postoperative 4th hour)
  • Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 1st hour(postoperative 1st hour)
  • Edema around the eye as assessed using 4-point Eyelid edema scale: Postoperative 2nd day(postoperative 2nd day)

研究者

发起方
University of Beykent
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Eda Tekin

Register nurse

University of Beykent

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