The influence of chewing combination of Pistacia atlantica gum and essential oil from Peppermint (Mentha Piperita L) on Xerostomia and Thirst of patients undergoing hemodialysis: A randomized controlled clinical trial
Determining the Influence of chewing the combination of Pistacia atlantica gum and Peppermint essence oil on Xerostomia and Thirst of patients undergoing hemodialysis
Design
A single-blinded, crossover-group, randomized clinical trial with repeated measures. Will be conducted on 72 hemodialysis patients. The randomization process will utilize blocks of 4 and 6.
Settings and conduct
Setting: The Hemodialysis Department at Imam Reza Hospital in Tabriz.
The providers of the chewing gum and the evaluators of the results will be blinded to the type of intervention.
Data collection and pre-test and post-test will be done by the trained researchers and they will not be aware of the division of participants into sequence A and B.
Participants/Inclusion and exclusion criteria
1. Treated with hemodialysis three times a week
2. Alert and having the ability to communicate verbally
3. Having natural teeth and the ability to chew gum
4. According to the standard question "how often does your mouth feel dry", answer frequently or always.
Intervention groups
Initially, all participants will be monitored without intervention for two weeks to measure Xerostomia and Thirst. Afterward, they will be divided into two groups, Sequence A and B.
Sequence A: Participants will first receive Peppermint Pistacia atlantica gum, then after a two-week washout period receive Pure Pistacia atlantica gum for two weeks.
Sequence B: Participants will receive pure Pistacia atlantica gum initially, then after a two-week washout period, they will use Peppermint Pistacia atlantica gum for two weeks.
Participants will receive packs of gum containing 21 pieces and will be instructed to use it three times a day for at least 20 minutes whenever they feel thirsty after each meal.
Main outcome variables
Xerostomia، Thirst
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221031056352N2
Registration date:2024-03-06, 1402/12/16
Registration timing:prospective
Last update:2024-03-06, 1402/12/16
Update count:0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
Mansour Ghafourifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
ghafourifardm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-14, 1403/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The influence of chewing combination of Pistacia atlantica gum and essential oil from Peppermint (Mentha Piperita L) on Xerostomia and Thirst of patients undergoing hemodialysis: A randomized controlled clinical trial
Public title
The influence of the chewing combination of Pistacia atlantica gum and essence of Peppermint on patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Patients with a definitive diagnosis of end-stage kidney disease based on medical records
Treated with hemodialysis three times a week or more regularly
Feeling of dry mouth in the last four weeks
Fully alert and having the ability to communicate verbally
Having natural teeth and the ability to chew gum
Absence of mouth ulcers
Having a personal mobile phone or the ability to read text messages
Absence of liver and biliary disorders and digestive refluxes
Patients who like the taste of mint
Not having habits of chewing gum continuously
Answer frequently or always according to the standard question, "How often does your mouth feel dry?"
Exclusion criteria:
Having head and neck cancer
Not being able to chew gum and not using it
Patients who change their hemodialysis center during the study period
Patient participation in another similar study
Death of the patient
Patients who change their treatment method
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of participants will be based on simple random block design with blocks of 4 and 6 and with the ratio of allocation one to one (1:1) to two sequences A and B.
In order to the allocation concealment, the method of Using Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) will be used. In this way, after creating a random sequence, based on the sample size, a number of opaque letter envelopes will be placed inside the letter envelopes in order to avoid the clarity of the contents of the envelopes. The numbering will be done in the same order. Finally, the lid of the envelopes will be glued and they will be placed in a box in order. At the time of the participation of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes The letter will be opened in order and the assigned group of that participant will be revealed. Randomization and preparation of letter envelopes will be done by someone other than the research team.
Blinding (investigator's opinion)
Single blinded
Blinding description
This cross-over clinical trial will involve two sequences of participants receiving both types of gum at scheduled intervals. Patient blinding is not feasible, and participants may notice a slight taste difference due to the mint flavor, although efforts will be made to match the gums in shape, size and color. The Pistacia atlantica gum's taste-reducing property will likely diminish the Mint flavor. The allocation sequence A and B will be blinded for examiners/assessors. The providers of the chewing gum and the evaluators of the results will be blinded to the type of intervention.
Data collection and pre-test and post-test will be done by the trained researchers and they will not be aware of the division of participants into sequence A and B.
Placebo
Not used
Assignment
Crossover
Other design features
Initially, all participants will undergo a two-week monitoring period without any intervention. Following this, the levels of Xerostomia and Thirst will be measured using specific instruments and compared to the baseline measurements. Subsequently, eligible patients will be randomly assigned to two sequences, A and B, utilizing random block sizes of 4 and 6, while ensuring a 1:1 ratio. In the interim: Group A will start with Peppermint Pistacia atlantica gum for two weeks and then switch to Pure Pistacia atlantica gum after a washout period, while Group B will follow the opposite sequence, starting with Pure Pistacia atlantica gum for two weeks and then switching to Peppermint pistacia atlantica gum after a two-week washout period. Patient data, including demographic and clinical information and questionnaire (Xerostomia Inventory (XI) and Dialysis Thirst Inventory (DTI)), will be collected. The primary outcomes are Xerostomia and Thirst, And secondary outcome is Intra Dialysis Weight Gain. The providers of the chewing gum and the evaluators of the results will be blinded to the type of intervention. Patient confidentiality will be maintained, and participants will be informed about the use of their data for research purposes and will receive the study results.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Science, Golgasht Street, Azadi street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2024-02-10, 1402/11/21
Ethics committee reference number
IR.TBZMED.REC.1402.855
Health conditions studied
1
Description of health condition studied
Hemodialysis care
ICD-10 code
Z49
ICD-10 code description
Encounter for care involving renal dialysis
Primary outcomes
1
Description
Xerostomia
Timepoint
The study will be evaluated Xerostomia before and after each period (The first two weeks, The second two weeks, The third two weeks, The fourth two weeks). T0: Before commencing the study, all patients undergo a two-week control period without any intervention. T1: End of the first two weeks (control period) T2: After the second two-week period, sequence A will be receive intervention 1 (Peppermint Pistacia atlantica gum) and sequence B will receive intervention 2 (Pure Pistacia atlantica gum). T3: End of the third two weeks (Washout) T4: End of the fourth two weeks sequence B will be receive intervention 1 (Peppermint Pistacia atlantica gum) and sequence A will receive intervention 2 (Pure Pistacia atlantica gum).
Method of measurement
Shortening Xerostomia Inventory (SXI)
2
Description
Thirst
Timepoint
The study will be evaluated Thirst before and after each period (The first two weeks, The second two weeks, The third two weeks, The fourth two weeks). T0: Before commencing the study, all patients undergo a two-week control period without any intervention. T1: End of the first two weeks (control period) T2: After the second two-week period, sequence A will be receive intervention 1 (Peppermint Pistacia atlantica gum) and sequence B will receive intervention 2 (Pure Pistacia atlantica gum). T3: End of the third two weeks (Washout) T4: End of the fourth two weeks sequence B will be receive intervention 1 (Peppermint Pistacia atlantica gum) and sequence A will receive intervention 2 (Pure Pistacia atlantica gum).
Method of measurement
Dialysis Thirst Inventory (DTI)
Secondary outcomes
1
Description
Intra Dialysis Weight Gain (IDWG)
Timepoint
The study will be evaluated Intra Dialysis Weight Gain (IDWG) before and after each period (The first two weeks, The second two weeks, The third two weeks, The fourth two weeks). T0: Before commencing the study, all patients undergo a two-week control period without any intervention. T1: End of the first two weeks (control period) T2: After the second two-week period, sequence A will be receive intervention 1 (Peppermint Pistacia atlantica gum) and sequence B will receive intervention 2 (Pure Pistacia atlantica gum). T3: End of the third two weeks (Washout) T4: End of the fourth two weeks sequence B will be receive intervention 1 (Peppermint Pistacia atlantica gum) and sequence A will receive intervention 2 (Pure Pistacia atlantica gum).
Method of measurement
Scale
Intervention groups
1
Description
Interventions: Initially, all participants will undergo a two-week monitoring period without any intervention. Following this, the levels of Xerostomia and Thirst will be measured using specific instruments and compared to the baseline measurements. Subsequently, eligible patients will be randomly assigned to two sequences, A and B, utilizing random block sizes of 4 and 6, while ensuring a 1:1 ratio. In the interim: Group A will start with Peppermint Pistacia atlantica gum for two weeks and then switch to Pure Pistacia atlantica gum after a washout period, while Group B will follow the opposite sequence, starting with pure Pistacia atlantica gum for two weeks and then switching to Peppermint Pistacia atlantica gum after a two-week washout period. Intervention 1 (combination of Pistacia atlantica gum with Peppermint essential oil): Each group (n=36) packs containing gum combined with Peppermint essential oil will be given to each one gram of gum with 1% of Peppermint essential oil. Patients will be told to use gum three times a day after each meal whenever they feel thirsty for at least 20 minutes. In order to ensure that participants adhere to the recommended intervention, the company will be asked to deliver empty packages of gum to the researcher and also daily by SMS or phone call all participants will be reminded of regular use of gum. It should also be noted that the routine treatment of thirst relief will not be changed. Each pack of gum will contain 21 pieces of gum. After two weeks of use of Peppermint gum, Xerostomia and Thirst will be measured using the relevant tools .Intervention Two (Pure Pistacia atlantica gum group): Each person in this group (n=36) will be given packages containing Pure Pistacia atlantica gum without any additives, each piece of gum will be 1 gram and no additives. Patients will be told to use gum three times a day after each meal whenever they feel thirsty for at least 20 minutes. In order to ensure the participants' adherence to the recommended intervention, participants are asked to deliver empty packages of gum to the researcher and also daily by SMS or phone call all participants will be reminded of regular use of gum. Each pack of gum will contain 21 pieces of gum. After two weeks of using Pure Pistacia atlantica gum, the Xerostomia and Thirst of the patients will be measured using the relevant tools .The researcher will ask the patients the questions and record their responses.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital of Tabriz
Full name of responsible person
Mojtaba mohammadzadeh lame
Street address
Golgasht Street ، Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
imamreza@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Central Building of University of Medical Sciences, Golgasht St, Azadi St, Tabriz.