Chewing Gum, Hemodialysis
Conditions
Keywords
Thirst, Weight gain
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.
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.
Interventions
DIETARY_SUPPLEMENTChewing 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.
Sponsors
Istanbul Demiroglu Bilim University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Intradialytic Weight Gain | 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 |
| Change From Baseline Feeling of Thirst at Three Months | 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. |
| Change From Baseline Dry Mouth at Three Months | 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. |
| Change From Baseline Intradialytic Symptoms at Three Months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Fluid Control at Three Months | 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. |
| Change From Baseline Depression at Three Months | 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. |
| Change From Baseline Anxiety at Three Months | 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. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Recruitment period: The assignment of patients to groups has began on October 14, 2019. It lasted on November 1, 2019.
Pre-assignment details
in chewing group: one person reject to join to the study. one person chewing clove.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Control Group The patients will not chewing gum during three months. | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 1 |
| Overall Study | Hospitalization | 0 | 2 |
| Overall Study | Referral to another hemodialysis unit | 3 | 2 |
| Overall Study | Use of clove | 0 | 1 |
Baseline characteristics
| Characteristic | Chewing Gum Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 44 Participants |
| Age, Continuous | 61.72 years STANDARD_DEVIATION 15.21 | 61.40 years STANDARD_DEVIATION 16.64 | 61.56 years STANDARD_DEVIATION 15.76 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 8 Participants | 22 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 28 | 1 / 28 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change From Baseline Dry Mouth at Three Months | 5.04 units on a scale | Standard Deviation 2.76 |
| Chewing Gum Group | Change From Baseline Dry Mouth at Three Months | 1.72 units on a scale | Standard Deviation 2.07 |
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.
Time frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change From Baseline Dry Mouth at Three Months | 5.04 ml/minute | Standard Deviation 2.76 |
| Chewing Gum Group | Change From Baseline Dry Mouth at Three Months | 1.72 ml/minute | Standard Deviation 2.07 |
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.
Time frame: At the end of the 1st, 6th, 12th week (3 hemodialysis sessions are done every week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change From Baseline Feeling of Thirst at Three Months | 5.04 score on a scale | Standard Deviation 2.76 |
| Chewing Gum Group | Change From Baseline Feeling of Thirst at Three Months | 1.72 score on a scale | Standard Deviation 2.07 |
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.
Time frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change From Baseline Intradialytic Symptoms at Three Months | 19.13 score on a scale | Standard Deviation 13.71 |
| Chewing Gum Group | Change From Baseline Intradialytic Symptoms at Three Months | 19.18 score on a scale | Standard Deviation 15.27 |
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
Time frame: up to 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change From Baseline Intradialytic Weight Gain | 2.53 kg | Standard Deviation 0.8 |
| Chewing Gum Group | Change From Baseline Intradialytic Weight Gain | 2.44 kg | Standard Deviation 0.95 |
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.
Time frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change From Baseline Anxiety at Three Months | 8.18 score on a scale | Standard Deviation 5.5 |
| Chewing Gum Group | Change From Baseline Anxiety at Three Months | 8.40 score on a scale | Standard Deviation 5.71 |
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.
Time frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change From Baseline Depression at Three Months | 8.63 score on a scale | Standard Deviation 4.9 |
| Chewing Gum Group | Change From Baseline Depression at Three Months | 8.13 score on a scale | Standard Deviation 4.31 |
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.
Time frame: At the end of the 1st and 12th week (3 hemodialysis sessions are done every week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Change From Baseline Fluid Control at Three Months | 53.95 score on a scale | Standard Deviation 6.06 |
| Chewing Gum Group | Change From Baseline Fluid Control at Three Months | 58.04 score on a scale | Standard Deviation 4.82 |