None listed
Conditions
Brief summary
Chronic heart failure is a progressive and burdensome syndrome with thirst as a major reason for non-compliance to self- care practices such as fluid restriction. Due to the life threatening effects of non- compliance to fluid restricted therapy, evidence based interventions are needed to manage thirst. Systematic evaluation of available strategies such as chewing gum is essential in ensuring that the best possible management is provided to CHF patients. The purpose of this study is to test the hypothesis that chewing gum can reduce thirst in people with chronic heart failure.
Interventions
The intervention involves the use of chewing gum (Xylitol, Epic Dental LLC peppermint flavour) to reduce thirst in patients with CHF. Consenting subjects will be randomised to each study arms. Study participants allocated to the chewing gum will be instructed to chew sugar free Xylitol, Epic Dental LLC peppermint flavour gum gently, for at least 10 minutes, six times a day and as desired throughout the day when the mouth feels dry or when they are thirsty. Participants in the no chewing gum gro
The intervention involves the use of chewing gum (Xylitol, Epic Dental LLC peppermint flavour) to reduce thirst in patients with CHF. Consenting subjects will be randomised to each study arms. Study participants allocated to the chewing gum will be instructed to chew sugar free Xylitol, Epic Dental LLC peppermint flavour gum gently, for at least 10 minutes, six times a day and as desired throughout the day when the mouth feels dry or when they are thirsty. Participants in the no chewing gum group will instructed to continue with what they normally use to relieve their thirst. Participants will continue the use of chewing gum for 2 weeks as part of the study protocol. After the 2 week intervention if subjects perceive there has been benefit in the use of chewing gum and the patient wishes to continue using the gum, they are allowed to do so. Monitoring of adherence to the intervention is performed through self- reporting. At the end of the trial participants will be asked to report their adherence to the intervention and if they are continuing to use the chewing gum.
Sponsors
University of Technology, Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged >18 years old 2. Heart failure as either primary or secondary diagnosis (as per NHFA and ESC guidelines) Definition: CHF: Is a complex syndrome characterised by underlying cardiac dysfunction (either associated with impaired or preserved systolic function) and typical symptoms of exercise intolerance. CHF with diastolic dysfunction: CHF with normal or near normal left ventricular (LV) ejection fraction (EF), normal or near normal LV volume, and evidence of diastolic dysfunction (e.g. abnormal pattern of LV filling and elevated filling pressures)[R][R]. 3. On oral loop diuretics 4. Able to safely chew and swallow 5. Able to provide informed consent 6. Able to read, speak and understand English
Exclusion criteria
1. On intravenous inotropes. Patients will be eligible once they have been weaned off the intravenous inotrope. 2. Unable to provide informed consent 3. People using chewing gum regularly 4. Restricted chewing and/or swallowing (i.e. due to dysphagia or other impairment)
Outcome results
None listed