Protocol summary

Summary
Objective:. The effect of topical application of sweet almond oil on the uremic pruritus and itchy quality of life in hemodialysis patients. Inclusion and exclusion criteria: Inclusion criteria include known cace of Chronic Renal Disease, under hemodialysis therapy at least 6months, suffering from pruritus to arise Chronic Renal Disease at least 2weeks, nonsuffering from known cace of pruriginous dermal disease and having age more than 18years and exclusion criteria include not to apply sweet almond oil, receive renal transplant, being under long term treatment with antihistamines or other pruritus sedative Medications. The study population: Hemodialysis patients referred to the dialysis center on Yasuj city. The sample size: By using block randomization 22patients in experimental and 20patients in control groups were allocated. Intervention: The amount of 5-10 ml of sweet almond oil made by Iranian Barij Essence pharmaceutical company was topically administrated in the test group once daily for two weeks but the control group received no specific intervention. Intervention time: Data were collected during three stages pre-intervention, the end of the first week and the second week after intervention. Primary outcomes: Uremic pruritus and itchy quality of life in hemodialysis patients.

General information

Acronym
Itchy QOL - HD
IRCT registration information
IRCT registration number: IRCT2014121520313N1
Registration date: 2015-02-06, 1393/11/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-02-06, 1393/11/17
Registrant information
Name
Zahra Mehri
Name of organization / entity
Yasuj University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 8820
Email address
zahra.mehri@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Science :20000000 Rial
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-10-02, 1392/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical application of sweet almond oil on the uremic pruritus and itchy quality of life in hemodialysis patients
Public title
The effect of sweet almond oil on the pruritus and quality of life in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: participant is known cace of Chronic Renal Disease and under hemodialysis therapy at least 6months; suffering from pruritus to arise Chronic Renal Disease at least 2weeks; participant has only suffering from Chronic Renal Disease and has not suffering from known cace of pruriginous dermal disease; participant has age more than 18years; participant is healthy Psychologically; participant has not conscious disorder; participant has not speaking disorder; participant has not hearing disorder; participant has not seeing disorder; participant has informed tendency to participate in study. Exclusion criteria: participant express noninclination to participate in study in any stage of study; participant do not to apply sweet almond oil during the study; participant dies during the study; participant emigrates from study invironment during the study; participant receive renal transplant during the study; participant being under long term treatment with antihistamines or other pruritus sedative Medications during the study.
Age
From 19 years old to 87 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yasuj University of Medical Science
Street address
Yasuj, Shahid Jalil boulevard, next to Emam Sajad hospital, Yasuj University of Medical Science .
City
Yasuj
Postal code
Approval date
2014-03-16, 1392/12/25
Ethics committee reference number
93.12.25.06

Health conditions studied

1

Description of health condition studied
uremic pruritus
ICD-10 code
L29.8
ICD-10 code description
Other pruritus

Primary outcomes

1

Description
uremic pruritus
Timepoint
one week pre-intervention , the end of the first week after intervention and the end of the second week after intervention
Method of measurement
severity scale questionnaire

2

Description
Itchy quality of life
Timepoint
one week pre-intervention , the end of the first week after intervention and the end of the second week after intervention
Method of measurement
Itchy quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group : Received no specific intervention .
Category
N/A

2

Description
Intervention group : From sweet almond oil made by Iranian Barij Essence pharmaceutical company with License registration number “ s – 90 – 050 “ was used. This oil is contained from 77% oleic acid and l7-20% inoleic, that method of application was once daily, amount of 5-10 ml in location of pruritus and locally depending on the location (any of the members or the entire body) for two weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dialysis Center of Yasuj Hospital Shahid Beheshti
Full name of responsible person
Dr Ardashir Afrasyabifar
Street address
Yasuj, Shahid Jalil boulevard, next to Emam Sajad hospital, Yasuj University of Medical Science, second floor, faculty of nursing and midwifery.
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Mahmood Naraki
Street address
Yasuj, Shahid Motahari boulevard, Setad, Central Building of Yasuj University of Medical Science, ground floor, office of an assistant of research
City
Yusuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Zahra Mehri
Position
Master of Medical Sergical Nursing
Other areas of specialty/work
Street address
Yasuj, Shahid Jalil boulevard, next to Emam Sajad hospital, Yasuj University of Medical Science, second floor, faculty of nursing and midwifery
City
Yasuj
Postal code
Phone
+98 74 3323 3701
Fax
Email
zahra.mehri@yums.ac.ir - afagh313@gmail.com - afagh313@chmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Dr Ardashir Afrasyabifar
Position
PHD in nursing
Other areas of specialty/work
Street address
Yasuj, Shahid Jalil boulevard, next to Emam Sajad hospital, Yasuj University of Medical Science, second floor, faculty of nursing and midwifery
City
Yasuj
Postal code
Phone
+98 74 3223 4115
Fax
+98 74 3223 4115
Email
afarsiabifar.ardashir@yums.ac.ir - afrasiabifar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Zahra Mehri
Position
Master of Medical Sergical Nursing
Other areas of specialty/work
Street address
Yasuj, Shahid Jalil boulevard, next to Emam Sajad hospital, Yasuj University of Medical Science, second floor, faculty of nursing and midwifery
City
Yasuj
Postal code
Phone
+98 74 3323 3701
Fax
Email
zahra.mehri@yums.ac.ir - afagh313@gmail.com - afagh313@chmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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