Heart FailureNCT05325983
Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation
A study testing lemonade ice cubes and water ice cubes in people with Heart Failure and Thirst, run by LI-JU Chen at 1 site in Taiwan.
Trial summary
The purpose of this study is to Using saliva stimulation to immediately improve heart failure inpatient's thirst sensation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Thirst, Saliva
- What is being tested?
- lemonade ice cubes and water ice cubes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jun 2020to 7 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Heart Failure, Thirst, Saliva
- Being tested
- lemonade ice cubes, water ice cubes
- Keywords
- Heart Failure, Thirst, Saliva stimulation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lemonade ice cubesOther
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 cubesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| lemonade ice cubes | Experimental | 10 ml lemonade ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively Receives: Other: lemonade ice cubes |
| water ice cubes | Placebo comparator | 10 ml water ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively Receives: Other: water ice cubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline and 180 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start24 Jun 2020
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- LI-JU Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LI-JU Chen, Chang Gung Memorial Hospital
- Investigators
- LI-JU Chen, Study chair, Self
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325983
- Sponsor's protocol ID
- 201901556B0
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Saliva Stimulation to Immediately Improve Heart Failure Inpatient's Thirst Sensation: A Double-blind, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05325983
- Acronym / sponsor ID
- 201901556B0
- Conditions
- Heart Failure, Thirst, Saliva
- Keywords
- Heart Failure, Thirst, Saliva stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- LI-JU ChenUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lemonade ice cubes | Experimental | Other: lemonade ice cubes10 ml lemonade ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively |
| water ice cubes | Placebo comparator | Other: water ice cubes10 ml water ice cubes in mouth, 45 seconds, 90 seconds, 135 seconds, 180 seconds respectively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lemonade ice cubesMixing 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. | Other | lemonade ice cubes |
| water ice cubesmake 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. | Other | water ice cubes |
Primary outcome
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LI-JU Chen study chair
Self
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lemonade ice cubes and water ice cubes in people with Heart Failure and Thirst, run by LI-JU Chen at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thirst intensity measured using an Visual Analogue Scale (VAS) (time frame: baseline and 180 second). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.