Assessing the effect of ice chips on thirst, xerostomia and Interdialytic weight gain in hemodialysis (HD) patients
Design
This study was a single group pretest- posttest study including 49 HD patients.
Settings and conduct
This study was conducted at three dialysis centers including Montserrie, Imam Reza and Hefdahe-Shahrivar in Mashhad
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who had received hemodialysis treatment, 3 times a week for at least 6 months, age between 18- 65 years, literacy, who are out of the home for less than 8 hours. Exclusion criteria: unwillingness to participate in the study, colds, fever, dental and mouth problems, consumption of angiotensin II inhibitor, diabetes and hepatitis B.
Intervention groups
This was a one- group pretest- posttest study including 49 hemodialysis patients. Instruction was performed at the baseline and patients received face to face instruction. In the fluid stage, patients took fluids only when they felt thirst and recorded their fluid intakes in the checklist. In the ice chip stage, patients received almost half of their required fluid through the use of ice chips and the other half through the use of liquid recorded their fluid and ice intakes in the checklist.the intervals between two dialysis sessions, patients were informed of the intervention and checklist completion was followed up Via SMS .Weight before and after and thirst and xerostomia one time before each dialysis session were measured.
Main outcome variables
Thirst, Interdialytic weight gain, Xerostomia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038140N1
Registration date:2020-03-02, 1398/12/12
Registration timing:retrospective
Last update:2020-03-02, 1398/12/12
Update count:0
Registration date
2020-03-02, 1398/12/12
Registrant information
Name
Hajareh Ebrahimi Rigi Tanha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3721 0483
Email address
ebrahimihajareh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-04-05, 1392/01/16
Expected recruitment end date
2013-06-19, 1392/03/29
Actual recruitment start date
2013-04-03, 1392/01/14
Actual recruitment end date
2013-05-30, 1392/03/09
Trial completion date
2013-05-30, 1392/03/09
Scientific title
Effect of ice chips on thirst, xerostomia and interdialytic weight gain in patients undergoing hemodialysis
Public title
Effect of ice chips on thirst, xerostomia and interdialytic weight gain
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
treatment with in-center hemodialysis 3 times weekly for a minimum of 6 months
age between 18- 65 years
literacy
who are less than 8 hours out of the home
Exclusion criteria:
Colds
Fever
Interdialytic weight gain overweight more than 5% of dry weight
Diabetes
Hepatitis B
Dental and mouth problems
Consumption of angiotensin II inhibitor
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Actual sample size reached:
49
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology; Qureshi Building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2012-11-29, 1391/09/09
Ethics committee reference number
IR.MUMS.REC.1391.704
Health conditions studied
1
Description of health condition studied
Patients undergoing hemodialysis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Thirst
Timepoint
Before each dialysis session
Method of measurement
Dialysis Thirst Inventory (DTI)
2
Description
Interdialytic weight gain
Timepoint
Before and after each dialysis session
Method of measurement
Digital scale
3
Description
Xerostomia
Timepoint
Before each dialysis session
Method of measurement
Xerostomia Inventory (XI)
Secondary outcomes
empty
Intervention groups
1
Description
Instruction was performed in the basic line stage; patients received face to face instruction. In the fluid stage, patients took fluids only when they felt thirst and recorded their fluid intakes in the checklist.In the intervention of the ice chip, patients received almost half of their required fluid through the use of ice chips and the other half through the use of liquid by sucking on ice chips the first time they felt thirsty, and the second time they were thirsty, they drank the liquid and the process continued. This method was chosen as there was no need of depriving patients of having water. Patient recorded their liquid intake, ice chips and the frequency of feeling thirst in the given checklists and brought them with themselves in the next dialysis session.the intervals between two dialysis sessions, patients were informed of the intervention and checklist completion was followed up Via SMS .Weight before and after, thirst and xerostomia one time before each dialysis session were measured.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Hajareh Ebrahimi Rigi Tanha
Street address
In front of Imam Reza Square-Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9914786138
Phone
+98 51 3802 2000
Email
ebrahimihajareh@gmail.com
2
Recruitment center
Name of recruitment center
Hefdahe Shahrivar Hospital
Full name of responsible person
Hajareh Ebrahimi Rigi Tanha
Street address
between 14th and 16th Kohsangi- Kohsangi Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9914786138
Phone
+98 51 3840 3015
Email
ebrahimihajareh@gmail.com
3
Recruitment center
Name of recruitment center
Montaserieh Hospital
Full name of responsible person
Hajareh Ebrahimi Rigi Tanha
Street address
In front of the Saba Building; Imam Khomeini 25 Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9914786138
Phone
+98 51 3229 1969
Email
ebrahimihajareh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Research and Technology; Qureshi Building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hajareh Ebrahimi Rigi Tanha
Position
Instructors
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Deputy of Research and Technology; Qureshi Building, Daneshgah street
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
ebrahimihajareh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hajareh Ebrahimi Rigi Tanha
Position
Instructors
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Deputy of Research and Technology; Qureshi Building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
ebrahimihajareh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hajareh Ebrahimi Rigi Tanha
Position
Instructors
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Deputy of Research and Technology; Qureshi Building, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
ebrahimihajareh@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available