The purpose of this study was to evaluate and compare the impact of massage using Chamomile oil, Almond oil and no oil on fatigue and quality of life in hemodialysis patients. 120 patients were randomly divided into control and 3 intervention groups. Randomization in this study was conducted using a random numbers table.
Inclusion criteria: Ability and willingness to cooperate and participate in the research; no infectious disease; no history of psychiatric disorder or psychiatric hospitalization or grief in the past 6 months; no receive any mental ability, memory or thinking disruptive treatment; no previous attendance in similar training or massage courses; age above 18 and below 85 years; male; having at least 3 dialysis sessions weekly.
Exclusion criteria: death; kidney transplantation during the study; unwillingness to continue participation.
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.
Main outcome measures: severity of fatigue and quality of life.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016121731438N1
Registration date:2017-08-02, 1396/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-02, 1396/05/11
Registrant information
Name
Osman Wosoi Dalavan
Name of organization / entity
Urmie University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 4961
Email address
parastari-bep@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research، Urmie University of Medical Sciences
Expected recruitment start date
2016-05-22, 1395/03/02
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Foot Massage with Chamomile Oil and Almond Oil on the severity of Fatigue and Quality of Life in hemodialysis Patients
Public title
The effect of Foot Massage with Chamomile Oil and Almond Oil on the severity of Fatigue and Quality of Life in hemodialysis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Ability and willingness to cooperate and participate in the research; no infectious disease; no history of psychiatric disorder or psychiatric hospitalization or grief in the past 6 months; no receive any mental ability, memory or thinking disruptive treatment; no previous attendance in similar training or massage courses; age above 18 and below 85 years; male; having at least 3 dialysis sessions weekly.
Exclusion criteria: death; kidney transplantation during the study; unwillingness to continue participation.
Age
From 18 years old to 84 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A sealed envelope
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmie University of Medical of Sceinces
Street address
Nazlo، Urmie
City
Urmie
Postal code
Approval date
2016-05-24, 1395/03/04
Ethics committee reference number
ir.umsu.rec.1394.340
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z99,2
ICD-10 code description
Renal dialysis status
Primary outcomes
1
Description
Quality Of Llife
Timepoint
Preintervention and Post Of Two 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
Control group:follow up without intervention
Category
N/A
2
Description
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
3
Description
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
4
Description
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
Urmie Imam Khomaini Hospital Hemodialys Unit
Full name of responsible person
Habib Zadeh Dr Hosein
Street address
Modarres Street، Urmie
City
Urmie
2
Recruitment center
Name of recruitment center
Urmie Taleghani Hospital Hemodialys Unit
Full name of responsible person
Habib Zadeh Dr Hosein
Street address
Kashani Street، Urmie
City
Urmie
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Urmie University of Medical Sciences
Full name of responsible person
Habib Zadeh Dr Hosein
Street address
Nazlo، Urmie
City
Urmie
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Urmie 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
Urmie University Of Medical Sciences
Full name of responsible person
Wosoi Dalavan Osman
Position
Master Of Nursing
Other areas of specialty/work
Street address
Nazlo، Urmie
City
Urmie
Postal code
Phone
+98 44 3346 9931
Fax
Email
osman.wosoi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urmie University Of Medical Sciences
Full name of responsible person
Habib Zadeh Dr Hosein
Position
Doctor
Other areas of specialty/work
Street address
Nazlo، Urmie
City
Urmie
Postal code
Phone
+98 44 3275 4961
Fax
Email
Habibz_h@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmie University Of Medical Sciences
Full name of responsible person
Wosoi Dalavan Osman
Position
master of nursing
Other areas of specialty/work
Street address
Nazlo، Urmie
City
urmie
Postal code
Phone
+98 44 3275 4961
Fax
Email
osman.wosoi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)