Comparison of the effect of Telangton's oyster massage with and without black seed oil on restless leg syndrome and the severity of muscle cramps in hemodialysis patients
Determining the effect of oyster type Telangton massage with black seed oil on restless leg syndrome and pain of muscle cramps in hemodialysis patients
Design
Randomized controlled clinical trial; with one control group, with parallel groups, single blind, phase 3 on 90 patients.
Settings and conduct
1- The place of this study is in the hemodialysis ward of Golestan Hospital in Ahvaz.
2- In this study, the research samples are not aware of the type of substance used for them during the massage.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Being in the age range of 18 to 65 years; Chronic renal failure undergoing regular and continuous hemodialysis for at least 6 months; regular dialysis program at least twice a week; Having 6 muscle cramps per month, getting a score of 4 from the Restless Legs Syndrome Questionnaire. Non inclusion criteria: History of mental illness; Open sores below the knee to the sole of the foot
Intervention groups
Intervention group 1: Tillingo massage by oyster method using black seed oil twice a week for three weeks and 10 ml each time.
Intervention group 2: Performing oyster massage by oyster method using paraffin oil (placebo) twice a week for three weeks and 10 ml each time.
Control group: Receiving routine interventions in the ward
Main outcome variables
Restless leg syndrome score; muscle cramp induced pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160726029086N6
Registration date:2021-08-06, 1400/05/15
Registration timing:registered_while_recruiting
Last update:2021-08-06, 1400/05/15
Update count:0
Registration date
2021-08-06, 1400/05/15
Registrant information
Name
Nasrin Elahi
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8071
Email address
elahi-n@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-26, 1400/03/05
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Telangton's oyster massage with and without black seed oil on restless leg syndrome and the severity of muscle cramps in hemodialysis patients
Public title
The effect of Telangton massage on restless legs syndrome and pain caused by muscle cramps
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the age range of 18 to 65 years
Chronic renal failure undergoing regular and continuous hemodialysis for at least 6 months
Perform a regular dialysis program at least twice a week
Having restless legs syndrome who get a score of 4
Muscle cramps according to the patient statement
Exclusion criteria:
History of mental illness
Open sores below the knee to the sole of the foot
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in groups of 30 will be randomly entered into the study using the block random allocation method with blocks of size six in two intervention and the control groups based on inclusion criteria. Randomization gives each participant an equal chance of being in each group. Blocking is used to balance the number of samples assigned to each of the groups studied.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the single blind method will be used. Thus, the participants (in the intervention group) are not informed about the type of oil consumed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences and Health Services, Vice Chanc
Street address
No.7; Azerbaijan Alley; Iqbal Street; Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2021-02-13, 1399/11/25
Ethics committee reference number
IR.AJUMS.REC.1399.892
Health conditions studied
1
Description of health condition studied
Restless legs syndrome and severe pain due to muscle cramps in patients with renal failure undergoing hemodialysis
ICD-10 code
N18.5
ICD-10 code description
نارسايي مزمن كليوي
Primary outcomes
1
Description
Change in the score of "restless legs syndrome" - the score obtained from the questionnaire is between 0 and 40, which indicates the severity of this disorder. A score of zero means that the person has no syndrome, and the higher the score, the more severe the disorder.
Timepoint
Before intervention and after intervention
Method of measurement
International Restless Legs Syndrome Questionnaire.
2
Description
Changes in pain intensity score of muscle cramps
Timepoint
Before and after intervention
Method of measurement
Use a checklist to record the severity of pain (VAS) and record the number of muscle cramps per month
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: receives oyster massage with 10 ml of black seed oil twice a week for three weeks. Massage from the soles of the feet to below the knees for 5 minutes.
Category
Treatment - Other
2
Description
Intervention group 2: receives oyster massage with 10 ml of paraffin oil (placebo) twice a week for three weeks. Massage from the soles of the feet to below the knees for 5 minutes.
Category
Placebo
3
Description
Control group: The control group will undergo routine care and treatment (such as surface massage).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis ward of Golestan Hospital
Full name of responsible person
Parvane Asadollahi
Street address
No.7; Azerbaijan Alley; Iqbal Street; Golestan
City
Ahvaz
Province
Khouzestan
Postal code
67111-63619
Phone
+98 61 3373 8331
Email
nasrinelahi137@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Street address
No.7; Azerbaijan Alley; Iqbal Street; Golestan
City
Ahvaz
Province
Khouzestan
Postal code
1635715794
Phone
+98 61 3373 8331
Email
nasrinelahi137@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No.7; Azerbaijan Alley; Iqbal Street; Golestan
City
Ahvaz
Province
Khouzestan
Postal code
1755673558
Phone
+98 61 3373 8395
Email
nasrinelahi137@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No.7; Azerbaijan Alley; Iqbal Street; Golestan
City
ahvaz
Province
Khouzestan
Postal code
1755673558
Phone
0088 61 33738395
Email
nasrinelahi137@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No.7; Azerbaijan Alley; Iqbal Street; Golestan
City
Ahvaz
Province
Khouzestan
Postal code
1633457694
Phone
+98 61 3373 8395
Email
nasrinelahi137@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after making individuals unidentifiable. Also data analysis becomes available.
When the data will become available and for how long
After the end of the study
To whom data/document is available
Related professors. Relevant students. Researchers working in academic and scientific institutions
Under which criteria data/document could be used
To use the treatment process for hemodialysis patients
From where data/document is obtainable
Refer to the responsible author for permission.
What processes are involved for a request to access data/document
Request by email to the responsible author.
elahi-n@ajums.ac.ir