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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chewing gum group | Experimental | The patients will be asked to chew on a regular chewing gum for three months. |
|
| Control group | No Intervention | The patients will not chewing gum during three months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nurten Ozen, Asst. Prof | Istanbul Demiroglu Bilim University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Demiroglu Bilim University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15458464 | Background | 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. | |
| 26197758 | Background |
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in chewing group: one person reject to join to the study. one person chewing clove.
Recruitment period: The assignment of patients to groups has began on October 14, 2019. It lasted on November 1, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | The patients will not chewing gum during three months. |
| FG001 | Chewing Gum Group | The patients will be asked to chew on a regular chewing gum for three months. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chewing Gum Group | The patients will be asked to chew on a regular chewing gum for three months. 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. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | kg | up to 12 weeks |
|
Up to 12 weeks.
Side effects were not monitored.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | The patients will not chewing gum during three months. | 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor Nurten Ozen | Demiroglu bilim University | +905334509382 | ozenurten@yahoo.com.tr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2020 | Apr 30, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002638 | Chewing Gum |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) |
| At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) |
| 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. | At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) |
| 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. | At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) |
| 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. |
| 27509571 | 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. |
| 21185739 | 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. |
| Referral to another hemodialysis unit |
|
| Use of clove |
|
The patients will not chewing gum during three months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week) |
|
|
|
| Primary | 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". | Posted | Mean | Standard Deviation | ml/minute | At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) |
|
|
|
| Primary | 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". | Posted | Mean | Standard Deviation | score on a scale | At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | At the end of the 1st and 12th week (3 hemodialysis sessions are done every week) |
|
|
|
| 28 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Chewing Gum Group | The patients will be asked to chew on a regular chewing gum for three months. 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. | 1 | 28 | 0 | 0 | 0 | 0 |
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| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |