Comparison the effect of reflexology and Swedish massage on sleep quality and restless leg syndrome among patients undergoing hemodialysis referred to Abu Ali Sina educational and medical center affiliated to Shiraz University of Medical Sciences in 2020
Comparison the effect of reflexology and Swedish massage on sleep quality and restless leg syndrome among patients undergoing Hemodialysis
Design
In the reflexology group, the researcher sits on a chair at the bottom of the patient's bed and performs a massage. This protocol will be performed on both legs for 20 minutes in 3 sessions. In the Swedish massage group, the researcher is placed at the bottom of the patient's legs, and first the patient is placed in an open arch position and a pillow is placed under the feet. The massage will be performed by the researcher for 20 minutes for 4 consecutive weeks. In the sham group, a simple knee-to-foot touch will be performed without compressing standard reflexology points with the same duration as the test group. There will be 30 people in each group to study.
Settings and conduct
The research environment will be Abu Ali Sina Educational-Therapeutic Hospital. After obtaining informed written consent from the patient, information related to demographic characteristics, sleep quality and restless legs syndrome will be obtained by interviewing in both intervention and control groups.
a specific number to each of the individuals studied, the person evaluating the consequences of the interventions is blinded by not knowing which person or type of intervention was involved.
Participants/Inclusion and exclusion criteria
Age range 18 to 76 years
At least 3 months of dialysis history
At least 3 times a week under hemodialysis
Intervention is prohibited in cases such as diabetic foot ulcers.
Lack of cooperation in more than 2 sessions
Intervention groups
In the sham group, routine care will be provided as usual, and in the intervention group, the procedure will be performed using foot reflexology and Swedish massage.
Main outcome variables
sleep quality, restless legs syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200613047746N1
Registration date:2020-06-18, 1399/03/29
Registration timing:prospective
Last update:2020-06-18, 1399/03/29
Update count:0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Alireza Ghanbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3731 3346
Email address
alinurse1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of reflexology and Swedish massage on sleep quality and restless leg syndrome among patients undergoing hemodialysis referred to Abu Ali Sina educational and medical center affiliated to Shiraz University of Medical Sciences in 2020
Public title
Comparison the effect of reflexology and Swedish massage on sleep quality and restless leg syndrome among patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age range is 18 to 76 years.
At least 3 months have passed since the start of their dialysis.
Have hemodialysis at least 3 times a week.
Medically, there is no barrier to intervention.
Exclusion criteria:
Any medical prohibition to perform the intervention such as diabetic foot wound
Lack of cooperation in more than 2 sessions of interventions
Age
From 18 years old to 76 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used to assign samples to three groups (Swedish massage, foot reflexology and control). Blocking will be done using online software (https://www.sealedenvelope.com/simple-randomiser/v1/lists).
The size of the blocks will be 6.
Using a lottery, each group will be assigned an A, B, and C label, and then samples will be assigned to each group based on a random block list.
Blinding (investigator's opinion)
Single blinded
Blinding description
By assigning a specific number to each of the individuals studied, the person evaluating the consequences of the interventions is blinded by not knowing which person has been subjected to which type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Beginning of the axis of Haft Bagh Alavi, Campus of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-06-02, 1399/03/13
Ethics committee reference number
IR.KMU.REC.1399.147
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
Sleep Quality
Timepoint
3 times a week for a month
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
1
Description
Restless Legs Syndrome
Timepoint
3 times a week for a month
Method of measurement
International Restless Legs Syndrome Questionnaire
Intervention groups
1
Description
Group 1: Hemodialysis patients under reflexology intervention. Massage at a slow pace with a regular or deep rhythm that would be tolerated by the patient. This protocol will be performed for 20 minutes on both feet (10 minutes for each foot) and in 3 sessions. Group II: Hemodialysis patients under Swedish massage intervention. Massage in this study will be performed once by dialysis for 20 minutes (10 minutes per foot) for 4 weeks (3 times per week) by the researcher.
Category
Rehabilitation
2
Description
Control group: In the sham or treatment group (control), by creating the same conditions as the test group, a simple touch of the knee to the sole of the foot without squeezing the standard reflexology points will be performed with the same duration of the test group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu-Ali Sina Hospital
Full name of responsible person
Alireza Ghanbari
Street address
Sadra, Fars Province
City
Shiraz
Province
Fars
Postal code
7145855487
Phone
+98 71 3344 0000
Email
alireza.a.ghanbari92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Research and Technology Dept. - Research Manager, Ibn Sina Ave.Tahmasebad Crossroad,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Alireza Ghanbari
Position
MSc student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Molavi Boulevard, 8th Alley
City
Shiraz
Province
Fars
Postal code
7145855487
Phone
+98 71 3731 3346
Email
Alinurse1371@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Parvin Mangolian Shahrbabaki
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5220
Email
mangolian167@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Alireza Ghanbari
Position
MSc student
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
Molavi Boulevard, 8th Alley
City
Shiraz
Province
Fars
Postal code
7145855487
Phone
009871337313346
Email
Alinurse1371@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The clinical report of this study will be presented in the form of an article.
When the data will become available and for how long
2 years
To whom data/document is available
researchers
Under which criteria data/document could be used
No specific conditions have been defined
From where data/document is obtainable
The author of the dissertation
What processes are involved for a request to access data/document