Chewing Gum in Hemodialysis Patients

NCT05241587 | Completed

• 1 other identifier: Nurse_haemo01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mouth Dryness; Nausea; Hemodialysis Complication; Nurse's Role; Thirst

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Effect of Xylitol Gum on nausea.

  6 weeks

• Effect of Xylitol Gum on salivary flow rate.

  6 weeks

• Effect of Xylitol Gum on oral pH.

  6 weeks

Study Arms (2)

The chewing gum group

EXPERIMENTAL

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.

Other: Gum Group:

The mouth spray group

EXPERIMENTAL

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.

Other: Mouth Spray Group:

Interventions

Gum Group: OTHER

Gum Group: 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).

The chewing gum group

Mouth Spray Group: OTHER

Mouth Spray Group: 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.

The mouth spray group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Didem Sarımehmet: lead

Study Sites (1)

Karadeniz Techinical University

Trabzon, (554) 326-3222, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 23826803 BACKGROUND

• Akgöz N, Arslan S (2017). Examination of Symptoms in Patients Who are on Hemodialysis Treatment. Journal of Nephrology Nursing, 12(1): 20-28.

  RESULT

MeSH Terms

Conditions

Xerostomia; Nausea

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Didem Sarımehmet, PhD

  Karadeniz Techinical University

  PRINCIPAL INVESTIGATOR

• Sevilay Hintistan, PhD

  Karadeniz Techinical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: This was a prospective, non-randomized experimental study involving a control group.

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 15, 2022
• Study Start: March 3, 2018
• Primary Completion: May 22, 2019
• Study Completion: December 12, 2020
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)