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临床试验/NCT07699809
NCT07699809招募中不适用

Administration of a 'Thirst Relieve Kit' Versus Placebo in Patients After Hospital-based Bowel Preparation for Colonoscopy and Assessment of Thirst Intensity

Hospital Sirio-Libanes1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2025年12月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
158
试验地点
1
主要终点
The primary outcome of the study is the intensity of thirst, assessed using a numerical scale (0-10) after administration of the thirst kit or placebo.

研究概览

简要总结

The goal of this study is to evaluate whether a "thirst kit" (lemon popsicle) is effective in reducing thirst intensity in patients undergoing hospital bowel preparation for colonoscopy. The study also aims to assess the impact of the thirst kit on associated symptoms and patient satisfaction. The main questions it aims to answer are:

  • Does the thirst kit reduce the intensity of thirst after bowel preparation for colonoscopy?
  • Does the thirst kit reduce symptoms such as dry mouth and dry throat?
  • How satisfied are patients when using the thirst kit compared to a placebo?

Researchers will compare the thirst kit to a placebo to determine its effectiveness in managing thirst during the pre-colonoscopy period.

Participants will:

  • Be randomly assigned to receive either the thirst kit (lemon popsicle) or a placebo
  • Use the assigned intervention during the hospital preparation period for colonoscopy
  • Rate thirst intensity, associated symptoms, and satisfaction using numerical scales

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
Triple (Care Provider, Investigator, Outcomes Assessor)

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

  • both sexes
  • aged 18 years or older, with clear awareness and good cooperation
  • who underwent colonoscopy with hospital bowel preparation

排除标准

  • any risk of oral fluid aspiration
  • swallowing disorders
  • post-operative advanced head and neck surgeries
  • advanced head and neck neoplasia, active oral diseases (oral mucosal lesions, stomatitis, among others)
  • history of gastric surgeries (gastrectomized, upper gastrointestinal tract surgeries for obesity)
  • use of GLP-1 analog medications and derivatives in the last 10 days according to hospital protocol (e.g., semaglutide, liraglutide, dulaglutide, tirzepatide...)
  • history of dementia.

研究组 & 干预措施

Intervention

Experimental

Group lemon popsicle: Group that will receive the lemon popsicle

干预措施: lemon popsicle (Other)

Placebo

Placebo Comparator

Group placebo: Group that will recive de placebo (water blister)

干预措施: Water blister pack (Other)

结局指标

主要结局

The primary outcome of the study is the intensity of thirst, assessed using a numerical scale (0-10) after administration of the thirst kit or placebo.

时间窗: 10 minutes before the sedation for the exam starts (when the patient arrives in the examination room)

The intensity of thirst, measured using a numerical scale from 0 to 10, was assessed after administration of the thirst kit or placebo in patients undergoing hospital preparation for colonoscopy.

次要结局

未报告次要终点

研究者

发起方
Hospital Sirio-Libanes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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