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Effect of Chewing Gum in Hemodialysis Patients

Primary Purpose

Chewing Gum, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Chewing Gum
Sponsored by
Istanbul Demiroglu Bilim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chewing Gum focused on measuring Thirst, Weight gain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Demiroglu Bilim University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Chewing gum group

Control group

Arm Description

The patients will be asked to chew on a regular chewing gum for three months.

The patients will not chewing gum during three months.

Outcomes

Primary Outcome Measures

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
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.
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.
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".
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".

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 24, 2019
Last Updated
May 12, 2020
Sponsor
Istanbul Demiroglu Bilim University
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1. Study Identification

Unique Protocol Identification Number
NCT04142216
Brief Title
Effect of Chewing Gum in Hemodialysis Patients
Official Title
Effect of Chewing Gum on Interdialytic Weight Gain, Thirst, Dry Mouth and Intradialytic Symptoms in Hemodialysis Patients: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 14, 2019 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Demiroglu Bilim University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chewing Gum, Hemodialysis
Keywords
Thirst, Weight gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chewing gum group
Arm Type
Experimental
Arm Description
The patients will be asked to chew on a regular chewing gum for three months.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients will not chewing gum during three months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chewing Gum
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline Intradialytic Weight Gain
Description
Interdialytic weight gain was defined as the difference between the predialytic weight and weight at the end of the previous dialysis session
Time Frame
up to 12 weeks
Title
Change From Baseline Feeling of Thirst at Three Months
Description
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.
Time Frame
At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
Title
Change From Baseline Dry Mouth at Three Months
Description
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.
Time Frame
At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
Title
Change From Baseline Dry Mouth at Three Months
Description
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".
Time Frame
At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Title
Change From Baseline Intradialytic Symptoms at Three Months
Description
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".
Time Frame
At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Secondary Outcome Measure Information:
Title
Change From Baseline Anxiety at Three Months
Description
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.
Time Frame
At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Title
Change From Baseline Fluid Control at Three Months
Description
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.
Time Frame
At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
Title
Change From Baseline Depression at Three Months
Description
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.
Time Frame
At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurten Ozen, Asst. Prof
Organizational Affiliation
Istanbul Demiroglu Bilim University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Demiroglu Bilim University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15458464
Citation
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.
Results Reference
background
PubMed Identifier
26197758
Citation
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.
Results Reference
background
PubMed Identifier
27509571
Citation
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.
Results Reference
background
PubMed Identifier
21185739
Citation
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.
Results Reference
background

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Effect of Chewing Gum in Hemodialysis Patients

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