Trial Outcomes & Findings for Effect of Chewing Gum in Hemodialysis Patients (NCT NCT04142216)
NCT ID: NCT04142216
Last Updated: 2020-05-21
Results Overview
Interdialytic weight gain was defined as the difference between the predialytic weight and weight at the end of the previous dialysis session
COMPLETED
NA
56 participants
up to 12 weeks
2020-05-21
Participant Flow
Recruitment period: The assignment of patients to groups has began on October 14, 2019. It lasted on November 1, 2019.
in chewing group: one person reject to join to the study. one person chewing clove.
Participant milestones
| Measure |
Control Group
The patients will not chewing gum during three months.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Control Group
The patients will not chewing gum during three months.
|
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.
|
|---|---|---|
|
Overall Study
Hospitalization
|
0
|
2
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Referral to another hemodialysis unit
|
3
|
2
|
|
Overall Study
Use of clove
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Chewing Gum Group
n=22 Participants
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.
|
Control Group
n=22 Participants
The patients will not chewing gum during three months.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=22 Participants
|
22 Participants
n=22 Participants
|
44 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=22 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=44 Participants
|
|
Age, Continuous
|
61.72 years
STANDARD_DEVIATION 15.21 • n=22 Participants
|
61.40 years
STANDARD_DEVIATION 16.64 • n=22 Participants
|
61.56 years
STANDARD_DEVIATION 15.76 • n=44 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=22 Participants
|
8 Participants
n=22 Participants
|
22 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=22 Participants
|
14 Participants
n=22 Participants
|
22 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: up to 12 weeksInterdialytic weight gain was defined as the difference between the predialytic weight and weight at the end of the previous dialysis session
Outcome measures
| Measure |
Control Group
n=22 Participants
The patients will not chewing gum during three months.
|
Chewing Gum Group
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline Intradialytic Weight Gain
|
2.53 kg
Standard Deviation 0.80
|
2.44 kg
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=22 Participants
The patients will not chewing gum during three months.
|
Chewing Gum Group
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline Feeling of Thirst at Three Months
|
5.04 score on a scale
Standard Deviation 2.76
|
1.72 score on a scale
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=22 Participants
The patients will not chewing gum during three months.
|
Chewing Gum Group
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline Dry Mouth at Three Months
|
5.04 units on a scale
Standard Deviation 2.76
|
1.72 units on a scale
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: 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".
Outcome measures
| Measure |
Control Group
n=22 Participants
The patients will not chewing gum during three months.
|
Chewing Gum Group
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline Dry Mouth at Three Months
|
5.04 ml/minute
Standard Deviation 2.76
|
1.72 ml/minute
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: 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".
Outcome measures
| Measure |
Control Group
n=22 Participants
The patients will not chewing gum during three months.
|
Chewing Gum Group
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline Intradialytic Symptoms at Three Months
|
19.13 score on a scale
Standard Deviation 13.71
|
19.18 score on a scale
Standard Deviation 15.27
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=22 Participants
The patients will not chewing gum during three months.
|
Chewing Gum Group
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline Anxiety at Three Months
|
8.18 score on a scale
Standard Deviation 5.50
|
8.40 score on a scale
Standard Deviation 5.71
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=22 Participants
The patients will not chewing gum during three months.
|
Chewing Gum Group
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline Fluid Control at Three Months
|
53.95 score on a scale
Standard Deviation 6.06
|
58.04 score on a scale
Standard Deviation 4.82
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Control Group
n=22 Participants
The patients will not chewing gum during three months.
|
Chewing Gum Group
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline Depression at Three Months
|
8.63 score on a scale
Standard Deviation 4.90
|
8.13 score on a scale
Standard Deviation 4.31
|
Adverse Events
Control Group
Chewing Gum Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Assistant Professor Nurten Ozen
Demiroglu bilim University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place