this study aimed to Investigate the effect of baby oil on pruritus and quality of life in hemodialysis patients. Participants were sampled from the list of hemodialysis patients in dialysis centers J. alaeme city of Kerman; taking into account the inclusion criteria. Study groups were matched for sex and itching score. Samples were randomly allocated in two intervention and control groups. In the beginning of the study short-form quality of life questionnaire (sf36) and visual analogue scale measuring the severity of itching were completed in both groups. Patients in the intervention group received baby oil at a rate of 3-5 ml for 15 minutes, During the 4-week course for 12 sessions during hemodialysis. Patients in the control group didn't receive teh intervention. In both groups after each session of hemodialysis SF-36 questionnaires as well as itching visual analogue scale were completed and measured.
General information
Acronym
HP
IRCT registration information
IRCT registration number:IRCT2017012532111N2
Registration date:2017-04-28, 1396/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-28, 1396/02/08
Registrant information
Name
Maryame Shahabi nejad
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
m_shahabi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
University will support the project through unit
Expected recruitment start date
2016-10-26, 1395/08/05
Expected recruitment end date
2016-12-15, 1395/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of baby oil on pruritus and quality of life in hemodialysis patients
Public title
The effect of baby oil on pruritus and quality of life in hemodialysis patients.
Purpose
Supportive
Inclusion/Exclusion criteria
(Inclusion criteria: hemodialysis three times a week; Age 18-60؛ At least two weeks pruritus; Dialysis using bicarbonate solution and polysulfane smoothness; The lake of a kidney transplant, skin problem or other than pruritus skin disease; Consent to participate in the study Exclusion criteria: If the transplant to be performed during the study; Feel free to use another method to reduce the pruritus)
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:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Not used
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Postal code
7717932777
Approval date
2016-05-30, 1395/03/10
Ethics committee reference number
IR.RUMS.REC.1395.75
Health conditions studied
1
Description of health condition studied
Pruritus in hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Care involving dialysis
Primary outcomes
1
Description
Severity of pruritus
Timepoint
Before and one month after intervention
Method of measurement
Itch Visual Analogue Scale
2
Description
Quality of Life
Timepoint
Before and one month after intervention
Method of measurement
Quality of Life Questionnaire SF-36
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Baby oil, Liquid paraffin, 3-5 ml,Local, Three times a week for a month, Company Firouz
Category
Other
2
Description
Control: No intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Jvadalaemeh Dialysis Center
Full name of responsible person
Ms. M. Shahabi
Street address
Abuzar Street
City
Rafsanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahabi nejad Maryam
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahabi nejad Maryam
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahabi nejad Maryam
Position
MSN
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
m_shahabin@rums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Shahabi nejad Maryam
Position
MSN
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Postal code
7717932777
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
m_shahabi@rums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
shahabi nejad Maryam
Position
MSN
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Imam Ali Boulevard, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
+98 34 3425 8497
Email
m_shahabi@rums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)