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The effect of topically applying fish oil on pruritus in hemodialysis patients

Protocol summary

Study aim
Investigating the Effects of Topical Fish Oil Application on Pruritus in Hemodialysis Patients at the Dialysis Center in Imam Khomeini Hospital, Jiroft, in 2022
Design
The clinical trial will include a control group and will be single-blind. A total of 70 patients will be assigned to either the intervention or control group using a simple random allocation method. To generate a simple random assignment sequence, the Stat Trek software will be employed.
Settings and conduct
Patients who meet the criteria will be enrolled in the study at the hemodialysis center of Imam Khomeini Hospital in Jiroft.The intervention group will receive fish oil twice a day for two weeks, in addition to routine care, while the control group will receive Vaseline twice a day for the same duration alongside routine care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individuals must be over 18 years of age Have experienced itching within the last two weeks without any identifiable cause such as a skin condition Have undergone hemodialysis treatment at least three times a week for the past six months Non-entry criteria: Having any hearing or speech impairments, treating itchiness with medication, having open wounds, deep vein thrombosis, epilepsy, bleeding disorders, paraplegia, cellulitis, or a pacemaker
Intervention groups
Intervention group: In this group, besides regular care, fish oil from Mehabani Natural Oils Company will be applied twice daily for a duration of two weeks. After washing the itchy area with lukewarm water and thoroughly drying it, 5 to 10 cc of fish oil will be topically applied to the affected area using the hand. Patients will be provided with fish oil in graduated containers.
Main outcome variables
pruritus

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211206053309N1
Registration date: 2024-07-25, 1403/05/04
Registration timing: prospective

Last update: 2024-07-25, 1403/05/04
Update count: 0
Registration date
2024-07-25, 1403/05/04
Registrant information
Name
Mohsen Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 8231 6557
Email address
info.mohsenabasi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topically applying fish oil on pruritus in hemodialysis patients
Public title
Examining the impact of fish oil on pruritus in individuals undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals must be over 18 years of age Have experienced itching within the last two weeks without any identifiable cause such as a skin condition Have undergone hemodialysis treatment at least three times a week for the past six months
Exclusion criteria:
Have any hearing or speech impairments Treating itchiness with medication. Have any open wounds, deep vein thrombosis, epilepsy, bleeding disorders, paraplegia, cellulitis, or a pacemaker
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be assigned to intervention and control groups using a simple randomization process. To generate a simple random assignment sequence, the Stat Trek software available at https://stattrek.com/statistics/random-number-generator.aspx will be employed. The assignment of samples to intervention and control groups will be carried out in accordance with the generated sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
The oils are stored in identical coded containers. Upon explaining the methodology and research goals, written informed consent will be obtained from the patient. The assistant researcher administers the oils to the patients. The researcher and statistician will not be aware of the nature of the collected data. Patients will be unaware of the group to which they belong.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jiroft University of Medical Sciences
Street address
Jiroft University of Medical Sciences, Pasdaran Street, Jiroft, Iran
City
Jiroft
Province
Kerman
Postal code
7861763444
Approval date
2023-01-18, 1401/10/28
Ethics committee reference number
IR.JMU.REC.1401.049

Health conditions studied

1

Description of health condition studied
Chronic kidney disease, stage 5, on dialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
pruritus
Timepoint
Before the intervention, at the end of two weeks following the intervention, before using the placebo, and after two weeks of using the placebo.
Method of measurement
Yosipovitch Questionnaire

Secondary outcomes

1

Description
Adverse effects of treatment (Skin Allergy)
Timepoint
days of 1, 3 ,7 after treatment
Method of measurement
Assessment and physical examination, question from patient

Intervention groups

1

Description
Intervention group: In this group, in addition to regular care, fish oil from Mehabani Natural Oils Company will be applied twice a day (morning and night at specific times) for two weeks. The fish oil should be administered after washing the itchy area with lukewarm water and then drying it. Apply 5 to 10 cc of fish oil topically to the affected area using your hand, adjusting the amount based on the size of the itchy area (5 cc for small areas, up to 10 cc for more widespread itching), until the symptoms disappear, for easier dosage tracking. Patients will receive the fish oil in graduated containers.search
Category
Treatment - Other

2

Description
Control group: This group will receive standard care, which includes education on diet and skin care. Vaseline (Vaseem brand) will be used as a placebo in this group. For the application of Vaseline, the itchy area should be washed with lukewarm water, dried, and then a 5 to 10 cc amount applied topically with the hand, depending on the size of the itchy area (at least 5 cc for a specific spot up to 10 cc for a more widespread itch) until the itchiness subsides. To facilitate measurement, Vaseline will be provided to patients in graduated containers.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mohsen Abbasi
Street address
School of Nursing and Midwifery, Shahid Qassem Soleimani Square, Jiroft, Kerman
City
Jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 34 4331 7623
Fax
+98 34 4331 6490
Email
info.mohsenabasi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Mohsen Abbasi
Street address
School of Nursing and Midwifery, Shahid Qassem Soleimani Square, Jiroft, Kerman
City
Jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 34 4331 6753
Fax
+98 34 4331 6490
Email
info.mohsenabasi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jeeroft 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
Jeeroft University of Medical Sciences
Full name of responsible person
Mohsen Abbasi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Qasem Soleymsni Square, Jiroft
City
Jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 34 4331 6753
Fax
+98 34 4331 6490
Email
info.mohsenabasi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Mohsen Abbasi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Qasem Soleymsni Square, Jiroft
City
Jiroft
Province
Kerman
Postal code
7861756447
Phone
+98 34 4331 6753
Fax
+98 34 4331 6490
Email
info.mohsenabasi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Mohsen Abbasi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Qasem Soleymsni Square, Jiroft
City
Jiroft
Province
Kerman
Postal code
7861756447
Phone
003443316753
Fax
+98 34 4331 6490
Email
info.mohsenabasi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The importance of maintaining the confidentiality of personal information
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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