The comparison of the effect of massage with lavender essence and orange essence on restless legs syndrome and quality of sleep in hemodialysis patients.
Objective: Comparison of the effect of foot massage with essential oil of lavander oil and orange essential oil on restless leg syndrome and sleep quality of patients undergoing hemodialysis. Design: a randomized clinical trial. Setting and conduct: Hemodialysis patients referring to Hospital Shahid beheshti and Besat in Hamadan for dialysis, are eligible for inclusion in the study. Inclusion criteria: Aged 18-65 years, have a history of at least 3 months of hemodialysis, answering "yes" to the first four questions of the restless leg syndrome questionnaire, no diabetic foot ulcers. Exclusion criteria: Failure to cooperate during study,A candidate for kidney trasplantation during the study. Intervention: 105 patients are randomly divided into 3 groups of 35 subjects after entering the study (lavender essential oil group, orange essential oil group and control group). Massage for 3 weeks and 3 times per week during hemodialysis for half an hour in the intervention group. In the control group, no massage is performed. Primary outcome: Sleepy sleep syndrome and sleep quality are measured before and after the first, second and third week, using the International Pittsburgh Sleep Disorder Syndrome Questionnaire. Secondary outcome: Nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071532303N3
Registration date:2017-08-31, 1396/06/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-31, 1396/06/09
Registrant information
Name
Morteza Shamsizadeh
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0535
Email address
shamsizadeh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effect of massage with lavender essence and orange essence on restless legs syndrome and quality of sleep in hemodialysis patients.
Public title
Effect of foot massage with essential oil of lavender and essential oil of orange on restless leg syndrome and sleep quality in hemodialysis patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Aged 18-65 years, have a history of at least 3 months of hemodialysis, have at least 3 sessions of hemodialysis per week, answering "yes" to the first four questions of the restless leg syndrome questionnaire, having sleep problem based on scores resulting from pittsburg questionnaire, no diabetic foot ulcers, no control of restless legs syndrome including antidepressants, no serious complications in the leg And foot ulcer and peripheral neuropathy and vascular problems in the lower limbs based on examination of the physician and the documentation in the case; Exclusion criteria: Failure to cooperate during study, A candidate for kidney trasplantation during the study, The onset of diabetic foot ulcers during the study,Discontinuation of hemodialysis sessions for any reason during the study( like traveling or kidnry transplant)
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The samples were randomly assigned to three groups of 35 people ( massage with essential oil of lavander, massage with orange essential oil and control group) by random blocking.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciencs
Street address
Fahmide Street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
651783-8698
Approval date
2017-06-22, 1396/04/01
Ethics committee reference number
IR.UMSHA.REC.1396.213
Health conditions studied
1
Description of health condition studied
Hemodialysis Patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, Stage 5
Primary outcomes
1
Description
Restless leg syndrome
Timepoint
Before the intervention, the first week, the second and third after the intervention
Method of measurement
Restless leg Syndrome Questionnaire
2
Description
Sleep quality
Timepoint
Before intervention. First, second and third weeks after intervention
Method of measurement
Pittsburgh questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First, a skin test was performed to ensure insensitivity and then massage with essential oil of lavender for half an hour during dialysis 3 times a week for 3 weeks totaling 9 times.
Category
Treatment - Other
2
Description
After performing the skin test and making sure that there was no sensitivity, massage was done with essential oil of orange for half an hour during hemodialysis 3 times a week for 3 weeks and 9 times in total.
Category
Treatment - Other
3
Description
There was no action in the control group and they received routine care.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Shahid Beheshti
Full name of responsible person
Fariba Mirzajani lotomi
Street address
Hamadan
City
Hamadan
2
Recruitment center
Name of recruitment center
Hospital Besat
Full name of responsible person
Fariba Mirzajani lotomi
Street address
Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Fariba Mirzajani Lotomi
Street address
Fahmide street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
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, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Fariba Mirzajani Lotomi
Position
Msn in Critical Care Nursing
Other areas of specialty/work
Street address
Fahmide street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
651783-8698
Phone
+98 81 3838 1480
Fax
+98 81 3838 0447
Email
f.mirzajani2016@gmail.com
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Khodayar Oshvandi
Position
Phd in Nursing,Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Fahmide street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
651783-8698
Phone
+98 81 3838 1480
Fax
+98 81 3838 0447
Email
oshvandi2005@yahoo.com
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Morteza shamsizadeh
Position
Ms, Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Fahmide street, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
651783-8698
Phone
+98 81 3838 1480
Fax
+98 81 3838 0447
Email
mortezashamsizadeh@gmail.com
Web page address
www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)