The purpose of this study was to evaluate and compare the impact of massage using lavender essence oil, orange essence oil and no oil on fatigue and quality of life in hemodialysis patients
Design
The purpose of this study was to evaluate and compare the impact of massage using lavender essence oil, orange essence oil and no oil on fatigue and quality of life in hemodialysis patients. 105 patients were randomly divided into control and 3 intervention groups.
Settings and conduct
Intervention: Massage will be done with the hand thenar and thumb finger with a brief compression, starting from the heel to the fingers, with use of noshad chamomile oil in group one and noshad almond oil in group two and no use of oils in group three for 10 Minutes for every foot.
Name of recruitment center: Shahid Modarres Hospital Kashmar
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having chronic renal insufficiency; Aged between 65-18years; Having the ability to speak in Persian; willingness to participate in research; Undergoing regular and consecutive hemodialysis from at least 6 months ago; Doing hemodialysis at least two times weekly. Exclusion criteria: death; kidney transplantation during the study; unwillingness to continue participation.
Intervention groups
Intervention group1: Massage will be done with the hand thenar and thumb Finger, start from the heel to the toes using 3 cc of lavender essence oil for 10 Minutes for every Foot.
Intervention group2: Massage will be done with the Hand Thenar and Thumb Finger, start from the heel to the toes with use of 3 cc of orange essence oil for 10 Minutes brief pressure for every Foot.
Intervention group 3: Massage will be done with the hand thenar and thumb Finger, start from the heel to the toes without use of oils for 10 Minutes brief pressure for every Foot.
Main outcome variables
Fatigue; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180711040432N2
Registration date:2019-01-13, 1397/10/23
Registration timing:prospective
Last update:2019-01-13, 1397/10/23
Update count:0
Registration date
2019-01-13, 1397/10/23
Registrant information
Name
Reza Mohammadpourhodki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5542 4875
Email address
rezamdpour@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-29, 1397/11/09
Expected recruitment end date
2019-05-26, 1398/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
survey the comparison of massage with lavender essence and orange essence effect on fatigue and quality of life in hemodialysis patients
Public title
survey the comparison of massage with lavender essence and orange essence effect on fatigue and quality of life in hemodialysis patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having chronic renal insufficiency
Aged between 65-18years
Having the ability to speak in Persian
willingness to participate in research
Undergoing regular and consecutive hemodialysis from at least 6 months ago
Doing hemodialysis at least two times weekly
Exclusion criteria:
Having chronic renal insufficiency
Aged between 65-18years
Having the ability to speak in Persian
willingness to participate in research
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated to groups using blocking randomization method.
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
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷۷۳۹۴۷
Approval date
2018-12-30, 1397/10/09
Ethics committee reference number
IR.SHMU.REC.1397.175
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Renal dial
ICD-10 code description
Z99,2
Primary outcomes
1
Description
Quality Of Llife
Timepoint
Preintervention and Post Of One Month Intervention
Method of measurement
With Use Of KDQOL-SF Questionnaire
2
Description
Severity of Fatigue
Timepoint
Preintervention and Post Of Two Month Intervention
Method of measurement
With Use Of FSS Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group1: Massage will be done with the Hand Thenar and Thumb Finger, start from the heel to the toes using 3 cc of Noshad chamomile oil for 10 Minutes for every Foot.
Category
Treatment - Other
2
Description
Intervention group: Intervention group2: Massage will be done with the Hand Thenar and Thumb Finger, start from the heel to the toes with use of 3 cc of Noshad Almond oil for 10 Minutes brief pressure for every Foot.
Category
Treatment - Other
3
Description
Control group: Intervention group 3: Massage will be done with the Hand Thenar and Thumb Finger, start from the heel to the toes without use of oils for 10 Minutes brief pressure for every Foot.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Reza Mohammadpourhodki
Street address
Shahid Modarres
City
Kashmar
Province
Razavi Khorasan
Postal code
۳۶۱۴۷۷۳۹۴۷
Phone
+98 23 3239 5054
Email
rezamdpoor@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Reza Mohammadpourhodki
Street address
Tehran
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
rezamdpoor@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Reza Mohammadpourhodki
Position
Educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
rezamdpoor@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Reza Mohammadpourhodki
Position
Educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran
City
shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
rezamdpoor@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Reza Mohammadpourhodki
Position
Eductor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
rezamdpoor@gmail.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
No more 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
No - There is not 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available