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Completed

NCT Number: NCT05325983

Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation

The purpose of this study is to Using saliva stimulation to immediately improve heart failure inpatient's thirst sensation.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Saliva Thirst

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Guishan, 333, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lemonade ice cubes

Other

Mixing 1 part lemon juice and 6 parts boiling water, make 10ml lemonade ice cubes. The experimental group was given a 10ml lemonade ice cube. The ice cubes were weighed first and then given. The subjects were required to hold the lemonade ice cube in their mouths without breaking them, and not to swallow saliva. 45 seconds after the intervention is given, the nurse will use tweezers to take out the ice cube from the subject's mouth and weigh it , and then place the dry cotton swab at the opening of the sublingual gland in the oral cavity, take it out after 1 minute, and collect saliva, the recorded saliva volume = the collected saliva volume minus (10 ml ice cube weight minus the remaining ice cube weight); The experimental group was given a brand new 10ml lemonade ice cube. At 90 seconds, 135 seconds and 180 seconds, the above saliva collection method was repeated for a total of 5 times of saliva collection.

water ice cubes

Other

make 10ml water ice cubes. The control group was given a 10ml water ice cube. The ice cubes were weighed first and then given. The subjects were required to hold the water ice cube in their mouths without breaking them, and not to swallow saliva. 45 seconds after the intervention is given, the nurse will use tweezers to take out the ice cube from the subject's mouth and weigh it , and then place the dry cotton swab at the opening of the sublingual gland in the oral cavity, take it out after 1 minute, and collect saliva, the recorded saliva volume = the collected saliva volume minus (10 ml ice cube weight minus the remaining ice cube weight); The control group was given a brand new 10ml water ice cube. At 90 seconds, 135 seconds and 180 seconds, the above saliva collection method was repeated for a total of 5 times of saliva collection.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

LI-JU Chen

Other

Registry information

Official study title

Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation: A Double-blind, Randomized Control Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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