Terminé

Evaluation of the Effect of Xylitol Gum on Thirst, Dry Mouth and Nausea in Patients Undergoing Haemodialysis

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Ce qui est testé

Gum Group:

+ Mouth Spray Group:

Autre
Qui peut participer

Maladies de la bouche+5

+ Maladies stomatognathiques

+ Nausée

À partir de 18 ans
+16 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude sur les services de santé

Interventionnel
Date de début : mars 2018
Voir le détail du protocole

Résumé

Sponsor principalDidem Sarımehmet
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 3 mars 2018

Date à laquelle le premier participant a commencé l'étude.

Haemodialysis is the most preferred method in the treatment of kidney failure in the world and in Turkey. According to the 2019 reports of the United States renal data system, haemodialysis is applied to 86.9% of the chronic kidney patients. In Turkey, this rate was 74.8% as of the end of 2018, according to the data reports of the Turkish Society of Nephrology. Patients undergoing haemodialysis have to cope with the adverse effects of the chronic disease as well as complications that develop due to treatment. Causes such as drugs used in haemodialysis treatment, fluid restriction, high ultrafiltration, weight gain between two haemodialysis sessions, dialysis imbalance syndrome and deterioration of oral pH, cause fluid-electrolyte imbalances, hypotension, pain, muscle cramps, thirst, dry mouth and leads of bothersome symptoms such as nausea. These may increase morbidity and mortality by causing premature termination of haemodialysis treatment or dialysis failure. Patients undergoing haemodialysis should be able to alleviate thirst, dry mouth and nausea with a method that does not disrupt fluid restriction. The combination of the salivary gland stimulant effect of the refreshing xylitol alone together with the mechanical effect of chewing gum has the effect of reducing thirst and dry mouth. Effective in reducing thirst, dry mouth and nausea in patients undergoing haemodialysis and a method that nurses can choose independently, xylitol gum can be easily used as a safe method and increases intraoral pH, prevents oral mucositis, facilitates periodontal healing and contributes to an effective treatment process. Thirst, dry mouth and nausea are quite common bothersome symptoms in patients undergoing haemodialysis. Thirst is a symptom associated with the desire to drink water due to insufficient body fluids and is one of the body's defence mechanisms. The inability of the saliva secreted to maintain the moistness of the oral mucosa is defined as "thirst". Thirst is controlled centrally and perceived peripherally as the feeling of dry mouth. According to Bots et al., 47.8% of patients on haemodialysis were thirsty during the day, 41.6% felt thirsty before dialysis, 24.7% during dialysis and 29.9% after dialysis. Dry mouth is a symptom that results from excessive reduction in the amount of saliva or problems with secretion, usually due to under-functioning of the salivary glands. When the amount of saliva decreases below 0.1 mL/min when evaluated together with clinical symptoms, it is defined as "dry mouth (xerostomia)". Bots et al. determined that 76.4% of the patients on haemodialysis treatment experienced dry mouth, while this figure was 56.2% according to Akgöz and Arslan. Thirst and dry mouth in patients on haemodialysis causes several clinical symptoms such as the sensations of sticky or burning tongue, need to drink liquid, difficulty swallowing solid food, stomatitis, increased dental caries, dysarthria and night sleep interruptions. Nausea is the conscious recognition of the excitation of a part of the vomiting centre or a closely related area and subjective feeling of the need to vomit. Increased urea concentration in the saliva of the patients and worsening of oral pH and exposure of the oral cavity to pathogens increase the risk of developing infection, disrupt the integrity of the mucous membrane and intensify the feeling of nausea Of the patients on haemodialysis treatment, 21-54% according to Almutary and 41% according to Akgöz and Arslan experienced nausea. Uncontrollable nausea can cause undesirable symptoms such as fluid-electrolyte imbalance, dehydration, vomiting, anorexia and weight loss, and also reduce the absorption and excretion of drugs used in the treatment. Based on the previous studies in the literature, xylitol gum, used generally as an auxiliary product in providing oral hygiene and preventing dental plaques and caries, has proven effects such as increasing saliva pH, protecting salivary proteins, reducing mouth and nasopharyngeal infections and protecting mucous membrane integrity. With its refreshing and pleasant taste, xylitol gum is also recommended as a natural, economical, easily accessible and safe product for reducing thirst, dry mouth and nausea in patients undergoing haemodialysis. However, studies evaluating the effect of xylitol gum on thirst and dry mouth in patients undergoing haemodialysis are limited in both the national and international literature. In addition, studies conducted with different sample groups and different methods (patients who underwent laparoscopic breast surgery, colonoscopy preparation, gynaecological operations) concluded that chewing gum reduces nausea but no study evaluating the effect of xylitol gum on nausea in patients undergoing haemodialysis could be found.

Titre officielEvaluation of the Effect of Xylitol Gum on Thirst, Dry Mouth and Nausea in Patients Undergoing Haemodialysis
NCT05241587
Sponsor principalDidem Sarımehmet
Dernière mise à jour : 28 janvier 2026
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

75 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Recherche sur les services de santé

Cette étude s'intéresse à la manière dont les soins de santé sont organisés et délivrés, et évalue l'efficacité de différents systèmes ou modèles de prise en charge.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Maladies de la boucheMaladies stomatognathiquesNauséeMaladies des glandes salivairesSignes et symptômesSignes et symptômes digestifsConditions pathologiques, signes et symptômesXérostomie

Critères

8 critères d'inclusion nécessaires pour participer
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,

Voir plus de critères

8 critères d'exclusion empêchent la participation
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,

Voir plus de critères

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Gum group patients consisted of patients who chewed "Xylitol Granule Filled Dragee Sugar Free Gum/Xylitol Gum/First X-Fresh". It is reported that the use of xylitol five times a day (not less than three times) is appropriate and effective (Xylitol, 2020; Xylitol, 2006; Llop, et al., 2010). Therefore, this group of patients was allowed to chew xylitol gum for 10 minutes, five times a day for six weeks.

Groupe II

Expérimental
The patients in the mouth spray group included those who had been using Oral Spray/Act Dry Mouth Spray regularly as two puffs three times a day at the request of the physician for the last two weeks. This group of patients continued to use the mouth spray at the physician's request.

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

Suspendu

Karadeniz Techinical University

Trabzon, Turkey (Türkiye)Ouvrir Karadeniz Techinical University dans Google Maps
Terminé1 Centres d'Étude