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The effect of ice chips containing menthol on the thirst of patients undergoing dialysis

Protocol summary

Study aim
The effect of ice chips containing menthol on the thirst of patients undergoing dialysis
Design
Randomized controlled clinical trial study- Single blind
Settings and conduct
This clinical trial study will carry out with participation of 60 patients undergoing dialysis referred to dialysis center in Birjand . Participants will be selected by convenient sampling and will be allocated randomly to either experimental (n=30) or control groups (n=30). The experimental group will receive ice chips containing menthol for a week and control group only will receive liquids as usual. Both groups will train on how to complete the check lists, measurement of liquids and fluid intake at intervals between sessions
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18 and 65 years old, Literacy of reading and writing (at least), 5000 to 10000 White blood cells per Micro-liter, Passing at least 6 month from dialysis, Conducting dialysis three times a week for 3 or 4 hours Exclusion criteria: History of Peritoneal dialysis, History of Kidney transplantation, Axillary temperature above 38.5, common cold, Pregnancy, Oral and dental problems interfering with consuming the ice chips, Smoking, Loss of consciousness, obvious mental or emotional disorders
Intervention groups
Intervention group, will received 12 pieces of ice chips containing menthol (one drop in 500 ml of water) with diameter of 3 cm and density of 0.5 cm daily (that will be provided by the researcher) and Control group will not receive any intervention . In both groups before each dialysis session, questionnaires of dialysis thirst duration, thirst distress of dialysis and thirst severity will be completed in the same condition.
Main outcome variables
Thirst severity, Thirst distress, Thirst duration, Dry mouth, Volume of consumed fluids

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190824044590N1
Registration date: 2020-08-11, 1399/05/21
Registration timing: retrospective

Last update: 2020-08-11, 1399/05/21
Update count: 0
Registration date
2020-08-11, 1399/05/21
Registrant information
Name
morteza abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3266 4751
Email address
morteza.abbasi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-13, 1398/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ice chips containing menthol on the thirst of patients undergoing dialysis
Public title
The effect of ice chips containing menthol on the thirst of dialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years old Literacy of reading and writing (at least) 5000 to 10000 White blood cells per Micro-liter Passing at least 6 month from dialysis Conducting dialysis three times a week for 3 or 4 hours.
Exclusion criteria:
Peritoneal dialysis Kidney transplantation Axillary temperature above 38.5. Common cold Pregnancy Oral and dental problems interfering with consuming ice chips Smoking Loss of consciousness, obvious mental or emotional disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
patients will be selected through convenience sampling and classified into intervention and control groups based on odd and even days.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding in patients is not possible; however the evaluator will not know the intervention type. patients on hemodialysis are randomly classified into two groups in odd and even days
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Birjand University of Medical Sciences
Street address
Ghaffari Ave, Birjand Town, Iran
City
Birjand
Province
South Khorasan
Postal code
9717613641
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
ir.bums.rec.1398.034

Health conditions studied

1

Description of health condition studied
Chronic renal failure
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease

Primary outcomes

1

Description
Severity of thirst
Timepoint
Before each dialysis session for one week
Method of measurement
Visual Analogue Scale (VAS)

2

Description
Thirst distress
Timepoint
Before each dialysis session for one week
Method of measurement
Welch Thirst Distress Scale

3

Description
Thirst duration
Timepoint
Before each dialysis session for one week
Method of measurement
Thirst duration form (DTI)

4

Description
Dry mouth
Timepoint
Before each dialysis session for one week
Method of measurement
Dry mouth form (XI)

5

Description
Volume of consumed fluids
Timepoint
Daily
Method of measurement
Checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients will receive 12 pieces of ice chips containing menthol (one drop in 500 ml of water) with diameter of 3 cm and density of 0.5 cm daily (that will be provided by the researcher).
Category
Other

2

Description
Control group: patients will not receive any intervention . before each dialysis session, questionnaires of dialysis thirst duration, thirst distress of dialysis and thirst severity will be completed in the same condition
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dialysis center, Birjand University of Medical Sciences
Full name of responsible person
Fatemeh Khaledi
Street address
Dialysis center, Shahid Beheshti Ave, Birjand, Iran.
City
Birjand
Province
South Khorasan
Postal code
9719873839
Phone
+98 56 3239 3000
Email
khas@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tuba Kazemi
Street address
Ghaffari Ave, Birjand Town, Iran
City
Birjand
Province
South Khorasan
Postal code
9719873839
Phone
+98 56 3244 0388
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zahra unesi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghaffari Ave, Birjand Town, Iran
City
Birjand
Province
South Khorasan
Postal code
9719873839
Phone
+98 56 3238 1425
Email
z-unesi@bums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zahra unesi
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghaffari Ave, Birjand Town, Iran
City
Birjand
Province
South Khorasan
Postal code
9719873839
Phone
+98 56 3238 1425
Email
z-unesi@bums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Morteza Abbasi
Position
Master’s student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ghaffari Ave, Birjand Town, Iran
City
Birjand
Province
South Khorasan
Postal code
9719873839
Phone
+98 56 3238 1425
Email
morteza.abbasi@bums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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