NCT04142216

Effect of Chewing Gum in Hemodialysis Patients

Completed NA Results posted Last updated 21 May 2020

What this trial tests

NA trial testing Chewing Gum in Chewing Gum in 56 participants. Completed in 30 January 2020.

Timeline

14 October 2019

Primary endpoint
10 January 2020

30 January 2020

Quick facts

Lead sponsor	Istanbul Demiroglu Bilim University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	56
Start date	14 October 2019
Primary completion	10 January 2020
Estimated completion	30 January 2020
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Chewing Gum — full drug profile →

Conditions studied

• Chewing Gum — all drugs for Chewing Gum →
• Hemodialysis — all drugs for Hemodialysis →

Sponsor

Istanbul Demiroglu Bilim University

Who can join

18 and older, any sex, with Chewing Gum or Hemodialysis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline Intradialytic Weight Gain Primary · 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

Group	Value	95% CI
Control Group	2.53	± 0.80
Chewing Gum Group	2.44	± 0.95

Change From Baseline Feeling of Thirst at Three Months Primary · 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.

Group	Value	95% CI
Control Group	5.04	± 2.76
Chewing Gum Group	1.72	± 2.07

Change From Baseline Dry Mouth at Three Months Primary · 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.

Group	Value	95% CI
Control Group	5.04	± 2.76
Chewing Gum Group	1.72	± 2.07

Change From Baseline Dry Mouth at Three Months Primary · 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".

Group	Value	95% CI
Control Group	5.04	± 2.76
Chewing Gum Group	1.72	± 2.07

Change From Baseline Intradialytic Symptoms at Three Months Primary · 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".

Group	Value	95% CI
Control Group	19.13	± 13.71
Chewing Gum Group	19.18	± 15.27

Change From Baseline Anxiety at Three Months Secondary · 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.

Group	Value	95% CI
Control Group	8.18	± 5.50
Chewing Gum Group	8.40	± 5.71

Change From Baseline Fluid Control at Three Months Secondary · 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.

Group	Value	95% CI
Control Group	53.95	± 6.06
Chewing Gum Group	58.04	± 4.82

Change From Baseline Depression at Three Months Secondary · 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.

Group	Value	95% CI
Control Group	8.63	± 4.90
Chewing Gum Group	8.13	± 4.31

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.