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Effect of Chewing Gum in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04142216
Recruitment Status : Completed
First Posted : October 29, 2019
Results First Posted : May 21, 2020
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
Nurten Ozen, Istanbul Demiroglu Bilim University

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.

Condition or disease Intervention/treatment Phase
Chewing Gum Hemodialysis Dietary Supplement: Chewing Gum Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Chewing Gum on Interdialytic Weight Gain, Thirst, Dry Mouth and Intradialytic Symptoms in Hemodialysis Patients: A Prospective Randomized Controlled Trial
Actual Study Start Date : October 14, 2019
Actual Primary Completion Date : January 10, 2020
Actual Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Change From Baseline Intradialytic Weight Gain [ Time Frame: up to 12 weeks ]
    Interdialytic weight gain was defined as the difference between the predialytic weight and weight at the end of the previous dialysis session

  2. Change From Baseline Feeling of Thirst at Three Months [ Time Frame: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week) ]
    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.

  3. Change From Baseline Dry Mouth at Three Months [ Time Frame: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week) ]
    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.

  4. Change From Baseline Dry Mouth at Three Months [ Time Frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) ]
    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".

  5. Change From Baseline Intradialytic Symptoms at Three Months [ Time Frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) ]
    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 :
  1. Change From Baseline Anxiety at Three Months [ Time Frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) ]
    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.

  2. Change From Baseline Fluid Control at Three Months [ Time Frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) ]
    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.

  3. Change From Baseline Depression at Three Months [ Time Frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142216


Locations
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Turkey
Demiroglu Bilim University
Istanbul, Turkey
Sponsors and Collaborators
Istanbul Demiroglu Bilim University
Investigators
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Principal Investigator: Nurten Ozen, Asst. Prof Istanbul Demiroglu Bilim University
  Study Documents (Full-Text)

Documents provided by Nurten Ozen, Istanbul Demiroglu Bilim University:
Publications:
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Responsible Party: Nurten Ozen, Assistant Professor, Istanbul Demiroglu Bilim University
ClinicalTrials.gov Identifier: NCT04142216    
Other Study ID Numbers: 2019/7
First Posted: October 29, 2019    Key Record Dates
Results First Posted: May 21, 2020
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nurten Ozen, Istanbul Demiroglu Bilim University:
Thirst
Weight gain
Additional relevant MeSH terms:
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Weight Gain
Body Weight Changes
Body Weight