One of the most prevalent problems in patients with ESRD with hemodialysis is the pruritus.The aim of this study also was to evaluate the effect of massage with/without aromatic oils on the pruritus relief of the patients undergoing hemodialysis.
This was a clinical trial study which cross-sectionally conducted in dialysis centers of Isfahan. Sampling was random sampling method.The study samples randomly divided into two groups.In the aromatic oil method, the aromatic oils combined from3-5ml of lavender, mint and tea tree oils with5% purity and in the non-aromatic oils method also sweet almond oil was used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303093560N2
Registration date:2013-05-08, 1392/02/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-08, 1392/02/18
Registrant information
Name
Nahid Shahgholian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2940
Email address
shahgholian@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center in Isfahan University of Medical Sciences
Expected recruitment start date
2009-05-24, 1388/03/03
Expected recruitment end date
2009-05-27, 1388/03/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect OF Massage With And Without Aromatic Oils On Pruritus Relife In Hemodialisis Patient
Public title
The Effect OF Massage With And Without Aromatic Oils On Pruritus Relife In Hemodialisis Patient
Purpose
Treatment
Inclusion/Exclusion criteria
All the patients undergo hemodialysis for more than 3 months. They underwent hemodialysis with bicarbonate solution . They had pruritus during two weeks before start sampling and had not taken any medication for pruritus relief and had no cutaneous problem except uremic pruritus
they had excluded from the study, if the patient underwent kidney transplantation during the study or had sensitivity to aromatic oils or provided that it was decided to set the fistula in the hand.
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib street , Isfahan
City
Isfahan
Postal code
Approval date
2009-04-03, 1388/01/14
Ethics committee reference number
388155
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.5
ICD-10 code description
N18.5
Primary outcomes
1
Description
Pruritus
Timepoint
Before and after the massage
Method of measurement
Pruritus scores
Secondary outcomes
empty
Intervention groups
1
Description
Massage for 7 minutes during 12 steps with sweet almond oil on without fistula arm
Category
Treatment - Drugs
2
Description
Massage with aromatic oil implemented for 7 minutes during 12 steps using aromatic oils of peppermint, lavender and tea tree which reached to 5% dilution using sweet almond oil on without fistula arm
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mahlagha Dehghan
Street address
Alzahra hospital-Sofe street-Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fariba Taleghani
Street address
No 4, Isfahan University of Medical Sciences, Hezar Jerib street , Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Maryam kianpour
Position
Academic Member
Other areas of specialty/work
Street address
No 4, Isfahan University of Medical Sciences, Hezar Jerib street , Isfahan
City
Isfahan
Postal code
Phone
00893117922934
Fax
Email
kianpour@mail.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Nahid Shahgholian
Position
MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib street , Isfahan
City
Isfahan
Postal code
Phone
00893117922940
Fax
Email
shahgholian@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Nahid Shahgholian
Position
MSc
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib street , Isfahan
City
Isfahan
Postal code
Phone
00893117922940
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)