Determining the effect of cold compress on the severity of uremic pruritus in hemodialysis patients
Design
clinical trial without control group and randomization
Settings and conduct
Participants complete the questionnaire before and four weeks after the intervention and score the severity of pruritus. A reminder table designed by the researcher is given to patients, including the number of itches per day and the usage of ice packs. Patients are asked to put jelly ice packs on itchy areas for 5-10 minutes between hemodialysis sessions whenever they experience pruritus. This study will be done in hemodialysis wards of Hashemi nezhad, Rasool Akram and Firoozgar Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria are No history of dermal and non-dermal itching diseases, No pregnancy and lactation, No hemodialysis due to acute renal failure, History of hemodialysis at least from 6 months ago, Suffering from pruritus at least for 2 weeks and exclusion criteria are Reluctance to continue participating in the study and Reluctance to use the cold compress
Intervention groups
Between their hemodialysis sessions, whenever itching occurs, put jelly ice packs which are provided for them first, in the freezer for 2 hours to freeze completely and then cover it with a layer of sterile gas which was also provided before, and then put it for five to ten minutes on the itchy areas
Main outcome variables
Number of the severity of uremic pruritus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220506054751N1
Registration date:2022-05-23, 1401/03/02
Registration timing:registered_while_recruiting
Last update:2022-05-23, 1401/03/02
Update count:0
Registration date
2022-05-23, 1401/03/02
Registrant information
Name
Kimiya Babakhaniyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8836 6311
Email address
babakhaniyan.ki@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-23, 1401/03/02
Expected recruitment end date
2022-06-23, 1401/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of applying cold compress on the severity of uremic pruritus in hemodialysis patients: A clinical trial
Public title
Effect of cold compress on the severity of pruritus in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No history of dermal and non-dermal itching diseases like Atopic dermatitis and chronic liver disease
No history of Allergy and chronic inflammation disorder
No pregnancy and lactation
No kidney transplantation
No hemodialysis due to acute renal failure
18-60 years old patients
Be able to read and write
History of hemodialysis at least from 6 months ago
Suffering from pruritus at least for 2 weeks
Hemodialysis 3 times a week and each time for 4 hours
Informed and conscious consent to participate in the study
Exclusion criteria:
Reluctance to continue participating in the study
Reluctance to use the cold compress
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
55
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
Research ethics committees of Iran University of Medical Sciences
Street address
Hemmat hwy, next to Milad tower
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-04-08, 1401/01/19
Ethics committee reference number
IR.IUMS.REC.1401.011
Health conditions studied
1
Description of health condition studied
Uremic pruritus
ICD-10 code
L29
ICD-10 code description
Pruritus
Primary outcomes
1
Description
Number of the severity of pruritus based on Visual Analogue Scale
Timepoint
Rating the severity of pruritus will be done in the start of intervention and 4 weeks later
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Between their hemodialysis sessions, whenever itching occurs, put jelly ice packs which are provided for them first (placed in a sealed plastic bag, weighing 300 g and measuring 2 x 17 x 25 cm), in the freezer for 2 hours to freeze completely and then cover it with a layer of sterile gas which was also provided before, and then put it for five to ten minutes on the itchy areas
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashemi Nezhad hospital
Full name of responsible person
Kimiya Babakhaniyan
Street address
Valinejad St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 81161
Email
support@hkc.ir
2
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Kimiya Bababkhaniyan
Street address
Behafarin St, Karimkhan St, Valiasr sq
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1600
Email
h_firoozgar@yahoo.com
3
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Kimiya Babakhniyan
Street address
Niyayesh St, Sattarkhan St
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5000
Email
rasoolhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Keivani
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Hwy
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research_m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Kimiya Babakhaniyan
Position
MSN student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing school of Iran University of Medical Sciences, Rashid Yasemi St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
babakhaniyan.ki@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kimiya Babakhaniyan
Position
MSN student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing school of Iran University of Medical Sciences, Rashid Yasemi St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
009892143651000
Email
babakhaniyan.ki@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kimiya Babakhniyan
Position
MSN student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing school of Iran University of Medical Sciences, Rashid Yasemi St, Valiasr Ave
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
babakhaniyan.ki@iums.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