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NCT Number: NCT04142216

Effect of Chewing Gum in Hemodialysis Patients

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.

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Key information

Conditions

Chewing Gum Body Weight Body Weight Changes Hemodialysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Demiroglu Bilim University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

chewing gum

Dietary Supplement

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istanbul Demiroglu Bilim University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2019
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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