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The Effect of Foot Reflexology on Restless leg syndrome and Sleep Quality in Patients with Multiple Sclerosis

Protocol summary

Study aim
Determining the effect of foot reflexology on restless leg syndrome and sleep quality in patients with multiple sclerosis
Design
This study is a clinical trial with two groups, double blinded and randomized, with 32 patients in each group.
Settings and conduct
This double blinded study, will be done in the Kerman Center of the Special Diseases. Foot reflexology in the intervention group will be performed 3 times per week by a trained researcher in the morning shift for 4 weeks, and in the afternoon three other days of the week, will be performed by the patient at home.The variables will be measured before, immediately and one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of RRMS, Having all four international criteria to diagnose restless legs syndrome, RLS severity score based on the questionnaire of RLS should be 11 or above 11,a total score of 6 or more based on the PSQI. Exclusion criteria: sensory and vascular disorders, orthopedic problems in the lower limbs, Having neurological diseases other than MS, pregnancy and diseases that cause RLS such as anemia, chronic kidney disease and chronic diseases such as cancer, chronic respiratory failure, heart failure, Mental illness such as depression, Taking medications that worsen RLS, such as antidepressants and dopamine antagonists, History of foot reflexology, Alcohol and drug addiction
Intervention groups
Foot reflexology in the intervention group will be performed for 4 weeks and 3 times per week for 20 minutes by a trained researcher in the morning shift and in the afternoon three other days of the week, will be done by the patient at home; While the control group will receive non-specific foot massage without pressing the standard reflexology points with the same conditions and duration.
Main outcome variables
Restless leg syndrome severity and Sleep Quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151107024919N15
Registration date: 2023-09-01, 1402/06/10
Registration timing: registered_while_recruiting

Last update: 2023-09-01, 1402/06/10
Update count: 0
Registration date
2023-09-01, 1402/06/10
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-31, 1402/05/09
Expected recruitment end date
2023-10-31, 1402/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Foot Reflexology on Restless leg syndrome and Sleep Quality in Patients with Multiple Sclerosis
Public title
The Effect of Foot Reflexology on Restless leg syndrome and Sleep Quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to communicate in Farsi Diagnosis of relapsing-remitting multiple sclerosis (RRMS), according to the patient's medical record Having all four international criteria to diagnose restless legs syndrome Restless leg syndrome severity score based on the questionnaire of the international study group of restless legs syndrome should be 11 or above 11. Having a sleep disorder (a total score of 6 or more based on the Pittsburgh Sleep Quality Index) Healthy and undamaged skin in the lower limbs
Exclusion criteria:
Paralysis, amputation, peripheral neuropathy, sensory disorders, vascular disorders, Coagulopathy, deformities or orthopedic problems in the lower limbs. Having neurological diseases other than MS, pregnancy and diseases that cause RLS such as anemia, chronic kidney disease and debilitating and chronic diseases such as cancer, chronic respiratory failure, heart failure, rheumatoid arthritis and lupus erythematosus, according to the patient's medical record Mental illness such as depression according to the patient's self-report Taking medications that worsen restless legs syndrome, such as antidepressants, selective serotonin reuptake inhibitors, antiemetics, anticonvulsants, and dopamine antagonists History of foot reflexology for the treatment of RLS or sleep disorder and use of other complementary and alternative therapies Alcohol and drug addiction
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups by block randomization method. For this purpose, the block size of 4 is used; So that two participants will be placed in each of the intervention and control groups within each block, and R software is used for this. Block randomization method. Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment.The block size is determined by the researcher and should be a multiple of the number of groups (i.e., with two treatment groups, block size of either 4, 6, or 8) The method used in this study is as follows: BABA"ABBA "AAB"BABA"BBAA" "BAAB "AAB "ABAB"BABA "AABB"BBAA"AABB "ABBA "BAAB"AABB"
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants and the statistician who will be responsible for data analysis will be blinded to the participants in the intervention and control groups. The data analyst does not know which data are related to the intervention group and which data are related to the control group. The information related to the intervention and control groups will be entered into SPSS software under the title of group 1 and group 2. The analyst will not know which of the groups 1 and 2 is the intervention and control groups.To avoid contamination between the intervention and control groups, foot reflexology will be performed on even days for the intervention group and for the control group, simple foot massage will be performed on odd days.
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
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-08-06, 1402/05/15
Ethics committee reference number
IR.KMU.REC.1402.143

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

2

Description of health condition studied
Restless legs syndrome
ICD-10 code
G25.8
ICD-10 code description
Other specified extrapyramidal and movement disorders

Primary outcomes

1

Description
Restless leg syndrome severity
Timepoint
The severity of Restless leg syndrome will be measured before the intervention, immediately after the intervention (at the end of the fourth week) and one month after the intervention.
Method of measurement
International Restless Legs Syndrome Study Group Rating Scale

2

Description
Sleep Quality
Timepoint
Sleep Quality will be measured before the intervention, immediately after the intervention (at the end of the fourth week) and one month after the intervention.
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Foot reflexology in the intervention group will be performed for 4 weeks and 3 times per week for 20 minutes (10 minutes for each foot) by a trained researcher in the morning shift and in the afternoon three other days of the week, except for the three days when the researcher performs the intervention in the morning shift, It is done at home by the patient herself.
Category
Other

2

Description
Control group: The control group will receive a non-specific foot massage without pressing the standard reflexology points with the same conditions and duration as the intervention group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical Center of the Special Diseases
Full name of responsible person
Batool Tirgari
Street address
Medical Center of the Special Diseases, No. 78 Alley, Shahid Rajaee Street,
City
Kerman
Province
Kerman
Postal code
7619875994
Phone
+98 34 3271 2001
Fax
+98 34 3271 2127
Email
b_tirgari@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abedin Iranpour
Street address
Razi Nursing and Midwifery School, Medical Sciences Campus, Haft baghe alavi Road, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Email
b_tirgari@kmu.ac.ir
Grant name
Vice-chancellor of research and technology, Kerman University of Medical Sciences
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
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir

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
Not applicable
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