Determine and compare the effect of Reflexology and Felorage Massage on the severity of fatigue and insomnia of patients with Multiple Sclerosis
Design
This research is a randomized clinical trial with control group. The sample size is 90. In this study, a non-invasive non-pharmacological method is used.
Settings and conduct
This study was conducted to compare the effects of two methods of non-pharmacological treatment Reflexology and Effleurage massage on fatigue and sleeplessness of patients referring to MS Society of Ahvaz. Sampling was performed based on entry criteria and cut-off point for data collection and intervention. Reflexology and massage of the eyelids, and use the Fatigue Intensive and Insomnia Inventory before and after the intervention and collect data from them.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 18 - 50 years old; willingness to participate in the study, and full awareness and health of the member. A score of 45 up to fatigue and gain a score of 22 up from the state of insomnia.
Exit criteria: increased severity of disease; recurrent disease during the process, and failure to follow the patient's or accompanying massage program and reflexology. The accompanying benchmark includes willingness to collaborate, literacy, and writing; the ability of the hands to massage the hands.
Intervention groups
Reflexology group, Effleurage massage group and control group
Comparison effect of Reflexology and Effleurage massage on the severity of fatigue and insomnia in Multiple Sclerosis patients
Public title
Effect Reflexology and Effleurage on fatigue and insomnia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range is 50-18 years.
Expressed willingness to participate in the study.
Full vigilance on the health of the legs and the lack of physical damage to the organs and spine.
Failure to have any motion sickness that impairs the performance of tests.
Not having surgery in the legs and legs in the last six months.
Lack of previous participation in complementary therapy sessions in the past six months
A definitive diagnosis of MS by a neurologist who has been at least six months since it was diagnosed.
Earn 45 or more points of fatigue and gain a score of 22 up from the state of insomnia
Exclusion criteria:
Increase the severity of the disease so that it affects the severity of fatigue and insomnia.
Recurrence of the disease and changes in the process of the disease so that the patient becomes hospitalized.
Failure to follow the massage or reflexology program by the patient or his companion for any reason.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Invited individuals are invited to enter the study and will be assigned to the study groups through random allocation of the block. Thus, in the beginning, according to the number of studied groups (three groups of two groups of subjects and one control group), the number of samples in each block is 3, and accordingly the number of blocks caused by all modes The ordering of individuals, by calculating the factorial of the number of samples per block, is 24 blocks, and the blocks involve the probable ordering of individuals, taking into account A for intervention 1 (reflexology) and B for intervention 2 (Forlo Ragh massage) and C for the control group Is being developed
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 Yasuj University of Medical Sciences
Street address
Yasuj-Shahid Motahari Blvd.-Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2019-04-22, 1398/02/02
Ethics committee reference number
IR.YUMS.REC.1398.007
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple Sclerosis
Primary outcomes
1
Description
Fatigue severity scale in FSS Fatigue Severity questionnaire
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Fatigue severity scale
Secondary outcomes
1
Description
Insomnia severity score
Timepoint
Before the intervention and two months after the intervention
Method of measurement
insomnia severity index questionnaire
Intervention groups
1
Description
Intervention group:Reflexology
Category
Treatment - Other
2
Description
Intervention group: Effleurage massage
Category
Treatment - Other
3
Description
Control group: Control
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple Sclerosis Society of Ahwaz
Full name of responsible person
Abdullah Poursamad
Street address
Golestan Avenue, Ahvaz Jundishapur University of Medical Sciences
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5935
Email
info@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Abdullah Poursamad
Street address
Yasuj-Shahid Motahari Blvd.-Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 1333 7251
Email
ab_poursamad@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Abdullah Poursamad
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasuj-Shahid Motahari Blvd.-Yasouj University of Medical Sciences
City
Yasuj-
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 743333723031
Fax
+98 74 3333 7230
Email
ab_poursamad@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Abdullah Poursamad
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasuj-Shahid Motahari Blvd.-Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 1333 7251
Email
ab_poursamad@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Abdullah Poursamad
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasuj-Shahid Motahari Blvd.-Yasouj University of Medical Sciences
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 1333 7251
Email
ab_poursamad@yums.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
Undecided - It is not yet known if there will be a plan to make this available