Nausea Clinical Trial
Official title:
Evaluation of the Effect of Xylitol Gum on Thirst, Dry Mouth and Nausea in Patients Undergoing Haemodialysis
Verified date | February 2022 |
Source | Karadeniz Technical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study was conducted to evaluate the effect of chewing xylitol gum on thirst, dry mouth and nausea in patients undergoing haemodialysis.Patients undergoing haemodialysis often experience thirst, dry mouth and nausea.This was a prospective, non-randomized experimental study involving a control group. The study was carried out with patients undergoing haemodialysis in a private dialysis centre in the northeast of Turkey between July and December 2018. It was completed with a total of 75 patients assigned to the gum group (n=25), mouth spray group (n=25), and control group (n=25).The patients in the gum group chewed xylitol gum for 10 minutes, five times a day for six weeks. Patients in the mouth spray group used two puffs of mouth spray three times a day. No intervention was made in the control group. Data were collected with the Patient Information Form, Charlson Comorbidity Index, Visual Analogue Scale, Rhodes Index of Nausea, Vomiting and Retching, graduated tube, and pH meter. Data were evaluated with Mann-Whitney U, Pearson Chi-square, Kruskal Wallis and Friedman tests. TREND checklist for non-randomised controlled trials was followed.
Status | Completed |
Enrollment | 75 |
Est. completion date | December 12, 2020 |
Est. primary completion date | May 22, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - being 18 years or older, - being able to speak and understand Turkish, - being oriented to person, place and time, - receiving haemodialysis treatment for at least three months, - experiencing dry mouth, thirst and nausea, - not having any chewing difficulties, - not having any dental prosthesis for the gum group, - using mouth spray for the last two weeks at the request of the physician for the mouth spray group. Exclusion Criteria: - exclusion criteria included having a mental, - hearing and speech impediment, - being diagnosed with a psychiatric disease, - using antiemetic drugs, being diagnosed with Sjögren's syndrome, - receiving radiotherapy or chemotherapy, - having a salivary gland infection, - previous salivary gland surgery, - sucking on ice cubes, chewing mint/lemon peels, and using mouthwash. |
Country | Name | City | State |
---|---|---|---|
Turkey | Karadeniz Techinical University | Trabzon |
Lead Sponsor | Collaborator |
---|---|
Didem Sarimehmet |
Turkey,
Akgöz N, Arslan S (2017). Examination of Symptoms in Patients Who are on Hemodialysis Treatment. Journal of Nephrology Nursing, 12(1): 20-28.
Almutary H, Bonner A, Douglas C. Symptom burden in chronic kidney disease: a review of recent literature. J Ren Care. 2013 Sep;39(3):140-50. doi: 10.1111/j.1755-6686.2013.12022.x. Epub 2013 Jul 4. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of chewing xylitol gum on thirst | Thirst were evaluated with "Visual Analog Score". VAS is a 10 cm or 100 mm long measuring instrument on a horizontal line with two different ends. The left end of the line is marked as "no" and the right end as "worst". | 6 weeks | |
Primary | Effect of chewing xylitol gum on dry mouth | Dry Mouth were evaluated with "Visual Analog Score". VAS is a 10 cm or 100 mm long measuring instrument on a horizontal line with two different ends. The left end of the line is marked as "no" and the right end as "worst". | 6 weeks | |
Secondary | Effect of Xylitol Gum on nausea. | Xylitol Gum on nausea in patients undergoing haemodialysis. Nausea was evaluated with Rhodes Nausea, Vomiting and Retching Index. The highest possible value in the index is 32, which indicates the most severe symptom for the patient. | 6 weeks | |
Secondary | Effect of Xylitol Gum on salivary flow rate. | Xylitol Gum on salivary flow rate in patients undergoing haemodialysis. Salivary flow rate with Saliva Flow Rate Measurement Tool (Graded Tube).Saliva flow >0.25 mL/min was considered "normal"; 0.1-0.25 mL/min "low"; <0.1 mL/min "hyposalivation" | 6 weeks | |
Secondary | Effect of Xylitol Gum on oral pH. | Xylitol Gum on oral pH in patients undergoing haemodialysis. Salivary pH with Oral Environment pH Measurement Tool (pH Meter). When the pH meter electrode is immersed in saliva, the pH value of the saliva is determined by the pH value on the screen. "0-6 pH" appearing on the pH meter screen is considered acidic, "7 pH" neutral, and "8-14 pH" alkaline" | 6 weeks |
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