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临床试验/NCT06249295
NCT06249295
已完成
不适用

The Efficacy of Postoperative Oral Cryotherapy in Sore Throat and Daily Life in Patients With Sleep Apnea

Chung Shan Medical University1 个研究点 分布在 1 个国家目标入组 64 人2024年1月31日

概览

阶段
不适用
干预措施
oral cryotherapy
疾病 / 适应症
Sleep Apnea, Obstructive
发起方
Chung Shan Medical University
入组人数
64
试验地点
1
主要终点
sore throat
状态
已完成
最后更新
上个月

概览

简要总结

The purpose of this study will to evaluate the degree of postoperative sore throat and Life Impairment changes in patients with sleep apnea who underwent da Vinci robotic arm surgery as an intervention of oral cryotherapy.

详细描述

An experimental study was conducted with 32 patients in the experimental group and 32 patients in the control group. The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies,and then intervened in the postsurgical period using oral cold therapy (ice lolly in the mouth),while the control group received general routine care. The control group received regular care. The assessment tools included the Pain Profile Scale and the Life Impairment Scale, and the assessment period was from the first day to the 14th day after the operation.

注册库
clinicaltrials.gov
开始日期
2024年1月31日
结束日期
2025年7月31日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Hsiang Chu Pai

Principal Investigator

Chung Shan Medical University

入排标准

入选标准

  • (1)Admission age is 18 years or above, conscious, able to communicate in Mandarin and Taiwanese, and willing to be measured and fill out the questionnaire after explaining the process and purpose of the study.
  • (2) The study was conducted in hospitalised patients diagnosed with sleep apnea who underwent surgery.

排除标准

  • (1) Diagnostic diagnosis of the disease not clearly known.
  • (2) Patients with unclear consciousness.
  • (3) Patients who have been diagnosed with mental illness before the diagnosis of the -
  • disease or recently diagnosed with mental illness.
  • (4) People with paraplegia or low behavioural ability.
  • (5) Patients who have suffered a stroke.

研究组 & 干预措施

Intervention group

The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies, and then intervened in the post-surgical period using oral cold therapy (ice lolly in the mouth).

干预措施: oral cryotherapy

control group

The control group received general routine care.

结局指标

主要结局

sore throat

时间窗: up to 2 weeks

The Pain Profile Scale assesses the pain level of the patient, which consists of 8 items: total pain level, throat pain level, throat pain during swallowing, ear pain during swallowing, difficulty swallowing, limitation of physical activity, oral odor, and sleep disruption, and other symptoms related to pain. The scoring criteria are based on a four-point scale: 0 for no sensation, 1 for mild, 2 for The scale is based on a four-point scale: 0 for no sensation, 1 for mild, 2 for moderate, and 3 for severe to present a multidimensional pain assessment.

次要结局

  • daily life(up to 2 weeks)

研究点 (1)

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