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

Sponsor
LI-JU Chen (Other)
Overall Status
Completed
CT.gov ID
NCT05325983
Collaborator
(none)
96
1
2
10.4
9.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: lemonade ice cubes
  • Other: water ice cubes
N/A

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
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Supportive Care
Official Title:
Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation: A Double-blind, Randomized Control Trial
Actual Study Start Date :
Jun 24, 2020
Actual Primary Completion Date :
May 7, 2021
Actual Study Completion Date :
May 7, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Thirst intensity measured using an Visual Analogue Scale (VAS) [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) [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. [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. [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. [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. [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Hospital stay for more than 24 hours;
    1. NYHA III-IV;
    1. Oral mucosa is intact, without ulcers or wounds;
    1. Consciousness and normal cognitive function;
    1. Those who are more than 20 years old and can answer the questionnaire in Chinese or Taiwanese verbally or in writing;
    1. Normal swallowing function;
    1. Stable vital signs and maintain systolic blood pressure above 90mmHg;
    1. Those who need to limit water according to doctor's advice
Exclusion Criteria:
    1. Those with endotracheal tube and respirator;
    1. Those with indwelling nasogastric tube;
    1. Those who fasted according to the doctor's advice;
    1. Those who were diagnosed with dry syndrome

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chang Gung Memorial Hospital Taoyuan Guishan Taiwan 333

Sponsors and Collaborators

  • LI-JU Chen

Investigators

  • Study Chair: LI-JU Chen, Self

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LI-JU Chen, Investigator, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05325983
Other Study ID Numbers:
  • 201901556B0
First Posted:
Apr 13, 2022
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by LI-JU Chen, Investigator, Chang Gung Memorial Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022