Effect of Chewing Gum in Hemodialysis Patients

Effect of Chewing Gum on Interdialytic Weight Gain, Thirst, Dry Mouth and Intradialytic Symptoms in Hemodialysis Patients: A Prospective Randomized Controlled Trial

The aim of this prospective randomized controlled study was to investigate the effects of chewing gum on interdialytic weight gain, thirst, dry mouth and intradialytic symptoms in hemodialysis patients.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Chewing Gum
• Intervention / Treatment: Dietary supplement: Chewing Gum

Detailed Description

The prevalence of xerostomia varies high in patients with chronic hemodialysis (HD), and the decreased saliva flow rate due to various mechanisms is the main factor in its development. The significant decrease in saliva flow due to the atrophy and fibrosis of the salivary glands in HD patients is further affected by the restriction in fluid intake. The use of drugs such as antidepressants, antipsychotics, antihistamines, antihypertensives, aspirin, benzodiazepines, opioids and proton pump inhibitors also leads to hyposalivation and xerostomia. Thirst is common in chronic HD patients due to both volumetric and osmometric causes but the primary mechanism is osmometric. The osmolarity of the extracellular fluid increases with the dietary salt and the hypothalamus is stimulated by the shrinkage of the osmoreceptor cells, leading to the desire to ingest liquids. Volumetric thirst develops secondary to water and salt loss and the resultant stimulation of cardiac baroreceptors, with the cardiac return volume decreasing gradually towards the end of the HD session. Increased interdialytic weight in HD patients causes increased risk of death due to cerebrovascular events and cardiovascular diseases and leads to an increase in morbidity and mortality together with a deterioration of the patient's quality of life. Interdialytic weight gain (IWG) causes incompliance with fluid control as a result of the secondary excessive consumption of liquid and food and is an important condition.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Demiroglu Bilim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• On maintenance hemodialysis three times per week for four hours per session
• Receiving hemodialysis therapy for a least six moths at the time of the study
• Able to communicate in Turkish
• Willing to participate to the study

Exclusion Criteria:

• 18 years of age younger
• Absence of psychiatric disorders that cause cognitive dysfunction, such as Alzheimer's disease or chronic psychosis.
• The patient who took chemotherapy and radiotherapy
• Have salivary gland infection and dementia
• Oral and / or dental diseases to prevent chewing gum
• Unwilling to to participate to the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Chewing gum group; The patients will be asked to chew on a regular chewing gum for three months.	Dietary supplement: Chewing Gum; The patients will chew one piece of regular chewing gum six times in a day and feeling of thirst for ten minutes for three months.
NO_INTERVENTION: Control group; The patients will not chewing gum during three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Intradialytic Weight Gain	Interdialytic weight gain was defined as the difference between the predialytic weight and weight at the end of the previous dialysis session	up to 12 weeks
Change From Baseline Feeling of Thirst at Three Months	It will be assessed three times at the end of the dialysis session with Visual Analogue. Thirst intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Thirst increases as the score increases. The high point describes bad outcome.	At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
Change From Baseline Dry Mouth at Three Months	It will be assessed three times at the end of the dialysis session with Visual Analogue Scale. Visual Analogue Scale ranging from 0 (no dry mouth) to 10 (worst dry mouth). Dry mouth increases the score increases. The high point describes bad outcome.	At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
Change From Baseline Dry Mouth at Three Months	It will be assessed two times at the end of the dialysis session with sample of saliva. Saliva flow rate/minute will be measured. Saliva flow rate/minute is presented with "ml".	At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Change From Baseline Intradialytic Symptoms at Three Months	It will be assessed with "Dialysis Symptom Index". Using this scoring system, the minimum possible total severity score was 0 if none of the 30 symptoms was present and the maximum potential. Score was 150 if all of the 30 symptoms were reported and rated as "very much bothersome". The minimum value is "0" and the maximum value is "150".	At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Anxiety at Three Months	It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression. Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.	At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Change From Baseline Fluid Control at Three Months	It will be assessed with "Fluid Control Scale in Hemodialysis Patients". the scale had 24 items and three subdimensions,namely, knowledge, behavior, and attitude. The lowest score obtained from the scale was 24 and the highest score was 72, and the higher the score, the greater the compliance of the patients with fluid control.	At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Change From Baseline Depression at Three Months	It will be assessed with Hospital Anxiety and Depression Scale. This scale, which has a two-factor structure is comprised of 14 items. Seven of these items assess the anxiety status and the remaining seven assess depression. Each item is scored on a four-point scale. Total score ranges between 0 and 21 for anxiety and depression. Scores between 0 and 7 indicate normal emotional status.	At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)

Collaborators and Investigators

• Sponsor: Istanbul Demiroglu Bilim University
• Investigators: Principal Investigator: Nurten Ozen, Asst. Prof, Istanbul Demiroglu Bilim University

Publications and helpful links

General Publications

• Bots CP, Brand HS, Veerman EC, Valentijn-Benz M, Van Amerongen BM, Valentijn RM, Vos PF, Bijlsma JA, Bezemer PD, Ter Wee PM, Amerongen AV. Interdialytic weight gain in patients on hemodialysis is associated with dry mouth and thirst. Kidney Int. 2004 Oct;66(4):1662-8. doi: 10.1111/j.1523-1755.2004.00933.x.
• Cabrera C, Brunelli SM, Rosenbaum D, Anum E, Ramakrishnan K, Jensen DE, Stalhammar NO, Stefansson BV. A retrospective, longitudinal study estimating the association between interdialytic weight gain and cardiovascular events and death in hemodialysis patients. BMC Nephrol. 2015 Jul 22;16:113. doi: 10.1186/s12882-015-0110-9.
• Duruk N, Eser I. The Null Effect of Chewing Gum During Hemodialysis on Dry Mouth. Clin Nurse Spec. 2016 Sep-Oct;30(5):E12-23. doi: 10.1097/NUR.0000000000000234.
• Jagodzinska M, Zimmer-Nowicka J, Nowicki M. Three months of regular gum chewing neither alleviates xerostomia nor reduces overhydration in chronic hemodialysis patients. J Ren Nutr. 2011 Sep;21(5):410-7. doi: 10.1053/j.jrn.2010.08.002. Epub 2010 Dec 24.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 14, 2019
• Primary Completion (ACTUAL): January 10, 2020
• Study Completion (ACTUAL): January 30, 2020

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (ACTUAL): October 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Thirst; Weight gain
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: 2019/7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No