Effect of Chewing Gum in Hemodialysis Patients

NCT04142216 | Completed Results

• 1 other identifier: 2019/7
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Chewing Gum; Hemodialysis

Keywords

Thirst; Weight gain

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Change From Baseline Anxiety at Three Months

  At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)

• Change From Baseline Fluid Control at Three Months

  At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)

• Change From Baseline Depression at Three Months

  At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)

Study Arms (2)

Chewing gum group

EXPERIMENTAL

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

Dietary Supplement: Chewing Gum

Control group

NO INTERVENTION

The patients will not chewing gum during three months.

Interventions

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.

Chewing gum group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead

Study Sites (1)

Demiroglu Bilim University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 15458464 BACKGROUND

• 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.

  PMID: 26197758 BACKGROUND

• 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.

  PMID: 27509571 BACKGROUND

• 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.

  PMID: 21185739 BACKGROUND

MeSH Terms

Conditions

Weight Gain

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Assistant Professor Nurten Ozen
• Organization: Demiroglu bilim University

ozenurten@yahoo.com.tr

+905334509382

Study Officials

• Nurten Ozen, Asst. Prof

  Istanbul Demiroglu Bilim University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 29, 2019
• Study Start: October 14, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 30, 2020
• Last Updated: May 21, 2020
• Results First Posted: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)