Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation: A Double-blind, Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Thirst distress measured using a Thirst Distress Scale-Heart Failure Taiwan version(TDS-HF)
Study Overview
Brief Summary
The purpose of this study is to Using saliva stimulation to immediately improve heart failure inpatient's thirst sensation.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
lemonade ice cubes
10 ml lemonade ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively
Intervention: lemonade ice cubes (Other)
water ice cubes
10 ml water ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively
Intervention: water ice cubes (Other)
Outcomes
Primary Outcomes
Thirst distress measured using a Thirst Distress Scale-Heart Failure Taiwan version(TDS-HF)
Time Frame: 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)
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported
Investigators
LI-JU Chen
Investigator
Chang Gung Memorial Hospital