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Investigating the comparative effect of effleurage massage with and without black seed oil on the sleep quality of restless leg syndrome patients undergoing hemodialysis

Protocol summary

Study aim
Investigating the comparative effect of effleurage massage with and without black seed oil on the sleep quality of restless leg syndrome patients undergoing hemodialysis
Design
Randomised clinical trial with control group, with control group, parallel groups, randomized, on 56 patients
Settings and conduct
The research community will be dialysis patients suffering from restless leg syndrome referring to Hami and Salam Arak Center. Patients will be divided into two control and intervention groups based on the randomized method. Patients of both groups will complete the sleep quality questionnaire 4 weeks after the beginning of the study. The patients of the intervention group will perform effleurage massage with the help of black seed solution for 4 weeks, three times a week, each time 20 minutes and one hour before sleep, and the control group will only perform effleurage massage.
Participants/Inclusion and exclusion criteria
Having the age of 18 to 65 years, performing hemodialysis at least 3 times a week for 4 hours, not having diabetic foot ulcers and amputations, not having debilitating and chronic diseases such as cancer, rheumatoid arthritis and rheumatoid arthritis, not having psychological disorders such as depression and bipolar disorders, not having Cardiovascular and skin disease, lack of physical and mental sensitivity to massage, not taking sleeping pills (sedatives)
Intervention groups
The intervention group was trained on how to perform exfoliation massage during two training sessions, and for 4 weeks, 3 times a week, for a total of 12 sessions, and each time for 20 minutes, every two hours, one hour before bedtime, with the help of black seed oil solution. will give Also, during this period, the control group performs exfoliation massage like the test group without using black seed oil solution.
Main outcome variables
Sleep quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240618062169N1
Registration date: 2024-06-22, 1403/04/02
Registration timing: prospective

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Tayebeh Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 6958
Email address
tybhqasmy654@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the comparative effect of effleurage massage with and without black seed oil on the sleep quality of restless leg syndrome patients undergoing hemodialysis
Public title
Effect of Efflorescence massage with and without black seed oil on hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having the age of 18 to 65 years Hemodialysis should be performed for patients at least 3 times a week and for 4 hours each time Not having physical and mental sensitivity to massage Not having cardiovascular and skin disease Not having psychological disorders such as depression and bipolar disorders Not having heart failure, lupus erythematosus Not having debilitating and chronic diseases such as various cancers and rheumatoid arthritis. No diabetic foot ulcers and orthopedic problems
Exclusion criteria:
Use Sedative drug
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: 56
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use simple random sampling. The sampling method will be as follows: 56 sheets (A = test) and (B = control) will be provided in equal form and placed in envelopes of the same shape and sealed. Then the eligible patients are asked to take an envelope from the bag containing the envelopes and they are placed in one of the two control or test groups based on the luck of the patients.
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 Arak University of Medical Sciences
Street address
Management of Research and Medical Information, Deputy of Research and Technology, University Complex of the Prophet (pbuh), Basij Square
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2024-06-02, 1403/03/13
Ethics committee reference number
IR.ARAKMU.REC.1403.102

Health conditions studied

1

Description of health condition studied
Restless leg syndrome in hemodialysis patients
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)

Primary outcomes

1

Description
Sleep quality score in the Pittsburgh Questionnaire
Timepoint
The beginning of the intervention (before the start of the intervention), 4 weeks after the start of the intervention.
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participating patients in the intervention group, along with their companions, will be taught how to perform effleurage massage in two face-to-face training sessions. Also, the patients of the test group will be asked to perform effleurage massage using 10 cc of black seed oil with a concentration of 5% from Tubi company. The patients of the test group will be asked to massage both legs for 4 weeks, 3 times a week, and a total of 12 sessions, each time for 20 minutes, one hour before going to bed. In addition, a group will be formed on Rubik's and WhatsApp , and for patients in the intervention group, links to educational materials related to effleurage massage and videos containing proper instruction on effleurage foot massage with black seed oil will be provided. Patients are also allowed to raise their questions and doubts in the virtual group and receive proper training from the researcher.
Category
Treatment - Other

2

Description
Control group: Participating patients in the control group, along with their companions, will see face-to-face training on how to perform effleurage massage in two training sessions. The patients of the control group will be asked to massage 3 times a week for 4 weeks and a total of 12 sessions, each time for 20 minutes on both legs, one hour before going to bed. In addition, a group will be formed on Rubik's messengers, and for patients in the intervention group, links to educational materials related to effleurage massage and videos containing proper instruction on effleurage foot massage with black seed oil will be provided. Patients are also allowed to raise their questions and doubts in the virtual group and receive proper training from the researcher.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
مرکز دیالیز سلام
Full name of responsible person
طیبه قاسمی
Street address
Arak, Javadalaima Street, not reaching Nowruz Square, next to the Prophet's (PBUH) Mosque, 3rd floor
City
Arak
Province
Markazi
Postal code
3817846868
Phone
+98 86 3226 3329
Fax
+98 21 8895 0897
Email
arak@salamdc.com

2

Recruitment center
Name of recruitment center
مرکز دیالیز حامی
Full name of responsible person
طیبه قاسمی
Street address
Hami Dialysis Center, Shahrak Gardo
City
Arak
Province
Markazi
Postal code
3817846868
Phone
+98 86 3477 9080
Email
pr_valiasr@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
مهدی صالحی
Street address
Deputy of Research and Technology, University complex of the great prophet (pbuh), Basij Squere, Sardasht
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Tayyaba Ghasemi
Position
Nursing master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak, Daneshgah Ave, Dadafrid St, in front of Qamar Bani Hashem High School
City
Arak
Province
Markazi
Postal code
3817846868
Phone
+98 86 3324 8179
Email
tybhqsmy654@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Jadidi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
646
Phone
009886331360558
Email
JADIDI.ALI83@YAHOO.COM

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Jadidi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
646
Phone
009886331360558
Email
JADIDI.ALI83@YAHOO.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
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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