search
Back to results

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

Primary Purpose

Heart Failure, Thirst, Saliva

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
lemonade ice cubes
water ice cubes
Sponsored by
LI-JU Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart Failure, Thirst, Saliva stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

lemonade ice cubes

water ice cubes

Arm Description

10 ml lemonade ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively

10 ml water ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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)

Secondary Outcome Measures

Full Information

First Posted
January 25, 2022
Last Updated
April 19, 2022
Sponsor
LI-JU Chen
search

1. Study Identification

Unique Protocol Identification Number
NCT05325983
Brief Title
Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation
Official Title
Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation: A Double-blind, Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2020 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
May 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
LI-JU Chen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Thirst, Saliva
Keywords
Heart Failure, Thirst, Saliva stimulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lemonade ice cubes
Arm Type
Experimental
Arm Description
10 ml lemonade ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively
Arm Title
water ice cubes
Arm Type
Placebo Comparator
Arm Description
10 ml water ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively
Intervention Type
Other
Intervention Name(s)
lemonade ice cubes
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
water ice cubes
Intervention Description
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 Outcome Measure Information:
Title
Thirst intensity measured using an Visual Analogue Scale (VAS)
Description
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)
Time Frame
baseline and 180 second
Title
Thirst distress measured using a Thirst Distress Scale-Heart Failure Taiwan version(TDS-HF)
Description
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)
Time Frame
baseline and 180 second
Title
Change from Baseline in Measure Saliva Amount at 45 seconds.
Description
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)
Time Frame
baseline and 45 second
Title
Change from Baseline in Measure Saliva Amount at 90 seconds.
Description
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)
Time Frame
baseline and 90 second
Title
Change from Baseline in Measure Saliva Amount at 135 seconds.
Description
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)
Time Frame
baseline and 135 second
Title
Change from Baseline in Measure Saliva Amount at 180 seconds.
Description
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)
Time Frame
baseline and 180 second

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LI-JU Chen
Organizational Affiliation
Self
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
State/Province
Guishan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs