Heart Failure Clinical Trial
Official title:
Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation: A Double-blind, Randomized Control Trial
NCT number | NCT05325983 |
Other study ID # | 201901556B0 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 24, 2020 |
Est. completion date | May 7, 2021 |
Verified date | April 2022 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to Using saliva stimulation to immediately improve heart failure inpatient's thirst sensation.
Status | Completed |
Enrollment | 96 |
Est. completion date | May 7, 2021 |
Est. primary completion date | May 7, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan | Guishan |
Lead Sponsor | Collaborator |
---|---|
LI-JU Chen |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Thirst intensity measured using an Visual Analogue Scale (VAS) | 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) |
baseline and 180 second | |
Primary | Thirst distress measured using a Thirst Distress Scale-Heart Failure Taiwan version(TDS-HF) | 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) |
baseline and 180 second | |
Primary | Change from Baseline in Measure Saliva Amount at 45 seconds. | 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) |
baseline and 45 second | |
Primary | Change from Baseline in Measure Saliva Amount at 90 seconds. | 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) |
baseline and 90 second | |
Primary | Change from Baseline in Measure Saliva Amount at 135 seconds. | 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) |
baseline and 135 second | |
Primary | Change from Baseline in Measure Saliva Amount at 180 seconds. | 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) |
baseline and 180 second |
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