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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Thirst; Saliva
• Intervention / Treatment: Other: lemonade ice cubes; Other: water ice cubes

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Guishan
    • Taoyuan, Guishan, Taiwan, 333
      • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lemonade ice cubes; 10 ml lemonade ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively	Other: lemonade ice cubes; 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.
Placebo Comparator: water ice cubes; 10 ml water ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively	Other: water ice cubes; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: LI-JU Chen
• Investigators: Study Chair: LI-JU Chen, Self

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2020
• Primary Completion (Actual): May 7, 2021
• Study Completion (Actual): May 7, 2021

Study Registration Dates

• First Submitted: January 25, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; Thirst; Saliva stimulation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 201901556B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No