Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation: A Double-blind, Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Thirst distress measured using a Thirst Distress Scale-Heart Failure Taiwan version(TDS-HF)
研究概览
简要总结
The purpose of this study is to Using saliva stimulation to immediately improve heart failure inpatient's thirst sensation.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will screening period to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomize in a double-blind manner (participant and researcher) in a 1:1 ratio to experimental group (lemonade ice cubes) or the control group (water ice cubes).
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 (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Hospital stay for more than 24 hours;
- •2. NYHA III-IV;
- •3. Oral mucosa is intact, without ulcers or wounds;
- •4. Consciousness and normal cognitive function;
- •5. Those who are more than 20 years old and can answer the questionnaire in Chinese or Taiwanese verbally or in writing;
- •6. Normal swallowing function;
- •7. Stable vital signs and maintain systolic blood pressure above 90mmHg;
- •8. Those who need to limit water according to doctor's advice
排除标准
- •1. Those with endotracheal tube and respirator;
- •2. Those with indwelling nasogastric tube;
- •3. Those who fasted according to the doctor's advice;
- •4. Those who were diagnosed with dry syndrome
研究组 & 干预措施
lemonade ice cubes
10 ml lemonade ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively
干预措施: lemonade ice cubes (Other)
water ice cubes
10 ml water ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively
干预措施: water ice cubes (Other)
结局指标
主要结局
Thirst distress measured using a Thirst Distress Scale-Heart Failure Taiwan version(TDS-HF)
时间窗: baseline and 180 second
The TDS-HF consists of 8 statements about how the patient experiences his/her thirst during the last 2-3 days (a total of 8 items). The 8 items are rated on a 5-point Likert scale. Patients are instructed to read each statement carefully and choose one of 5 possible answers for each statement that best describes the patients experience of thirst between strongly disagree (on the left side, number 1) and strongly agree (on the right side, number 5). Change= (180 second score - baseline score)
Thirst intensity measured using an Visual Analogue Scale (VAS)
时间窗: baseline and 180 second
The VAS is a 100 mm line with anchor statements on the left (score :0 mm , no thirst) and on the right (score: 100 mm, extreme thirst). Change= (180 second score - baseline score)
Change from Baseline in Measure Saliva Amount at 180 seconds.
时间窗: baseline and 180 second
Uses a dry cotton stick to place the sublingual gland opening in the subject's oral cavity for 1 minute, and collects the amount of saliva (baseline measurement; T0); then the intervention is performed Measures, 180 seconds (T4) after the intervention During the test, the nurse took out the ice cubes from the subject's mouth with tweezers and weighed it, and then placed the dry cotton swab at the opening of the sublingual gland in the oral cavity, took it out after 1 minute, and collected saliva. Weigh it with an electronic scale with a minimum weight of 0.01 grams, and assume that 1 gram is equal to 1 milliliter. Change= (180 second score - baseline score)
Change from Baseline in Measure Saliva Amount at 45 seconds.
时间窗: baseline and 45 second
Uses a dry cotton stick to place the sublingual gland opening in the subject's oral cavity for 1 minute, and collects the amount of saliva (baseline measurement; T0); then the intervention is performed Measures, 45 seconds (T1) after the intervention During the test, the nurse took out the ice cubes from the subject's mouth with tweezers and weighed it, and then placed the dry cotton swab at the opening of the sublingual gland in the oral cavity, took it out after 1 minute, and collected saliva. Weigh it with an electronic scale with a minimum weight of 0.01 grams, and assume that 1 gram is equal to 1 milliliter. Change= (45 second score - baseline score)
Change from Baseline in Measure Saliva Amount at 90 seconds.
时间窗: baseline and 90 second
Uses a dry cotton stick to place the sublingual gland opening in the subject's oral cavity for 1 minute, and collects the amount of saliva (baseline measurement; T0); then the intervention is performed Measures, 90 seconds (T2) after the intervention During the test, the nurse took out the ice cubes from the subject's mouth with tweezers and weighed it, and then placed the dry cotton swab at the opening of the sublingual gland in the oral cavity, took it out after 1 minute, and collected saliva. Weigh it with an electronic scale with a minimum weight of 0.01 grams, and assume that 1 gram is equal to 1 milliliter. Change= (90 second score - baseline score)
Change from Baseline in Measure Saliva Amount at 135 seconds.
时间窗: baseline and 135 second
Uses a dry cotton stick to place the sublingual gland opening in the subject's oral cavity for 1 minute, and collects the amount of saliva (baseline measurement; T0); then the intervention is performed Measures, 135 seconds (T3) after the intervention During the test, the nurse took out the ice cubes from the subject's mouth with tweezers and weighed it, and then placed the dry cotton swab at the opening of the sublingual gland in the oral cavity, took it out after 1 minute, and collected saliva. Weigh it with an electronic scale with a minimum weight of 0.01 grams, and assume that 1 gram is equal to 1 milliliter. Change= (135 second score - baseline score)
次要结局
未报告次要终点
研究者
LI-JU Chen
Investigator
Chang Gung Memorial Hospital