The effect of foot reflexology on patients with MS
Design
In this study, 60 patients with MS with entry criteria are selected. Patients are randomly assigned to control and intervention groups using random numbers. Each group was assigned a code to hide the groups.
Settings and conduct
Janbazan Clinic of Arak City
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 50 years old; conscious informed consent of the patient; EDSS is less than or equal to 4: Expanded Disability Status Scale (EDSS) scale that measures the severity of MS patient disability.
Exit criteria: the presence of deformity or ulcer in the areas of massage on the palms of the feet; there is a burn, fungal infection, varice and warts, cornea and any kind of numbness in the leg; having problems with the legs, including problems with blood flow (confirmed by the cardiologist); use of hypnotic and antipyretic drugs, antidepressants and analgesics during the study; anemia, renal failure, liver, diabetes, thyroid disorders and urinary tract infection; use of other alternative and alternative methods during the study; patient's lack of consent to continue cooperation.
Intervention groups
In the intervention group, patients will undergo 8 reflexology sessions twice a week for 4 weeks. Each session is performed for 30 minutes and for each foot for 15 minutes, including 5 minutes for general massage of the foot and 10 minutes for massage on the pituitary glands, hypothalamus, pineal gland on the thumb and continue with massage On the solar cell will be done.
Patients in the control group do not receive any reflexology intervention on the part of the researcher. At the end of the eighth week, the same questionnaires will be filled in before the intervention.
Main outcome variables
Quality of sleep
fatigue
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038211N3
Registration date:2018-05-07, 1397/02/17
Registration timing:prospective
Last update:2018-05-07, 1397/02/17
Update count:0
Registration date
2018-05-07, 1397/02/17
Registrant information
Name
Fahime Davodabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 7610
Email address
F_davodabady@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on sleep quality, fatigue and anxiety in patients with MS
Public title
Effect of foot reflexology in MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with MS who have Expanded Disability Status Scale (EDSS) are equal to or less than 4.
Patients with MS aged 18 to 50 years old
Conscious informed consent of the patient
Exclusion criteria:
There is any problem in the foot massage areas
Use of other complementary and alternative methods during the study
Anemia, renal failure, liver failure, diabetes, thyroid disorders and urinary tract infection
Sleeping and sedative medications, antidepressants and analgesics during the study
Having problems with the legs, including problems with blood flow (confirmed by the cardiologist)
The presence of burn, fungal infection, varicose veins, warts, corns and any kind of numbness in the leg
The presence of deformity or ulcer in the area of massage on the palms of the feet
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals with entry criteria are divided into two intervention and control groups according to the random numbers table. The people of the intervention group A and the control group B are called. Before and after the intervention, the information is collected by the evaluator of the outcome that is unaware of the grouping of the groups. Data analysis is also done by someone who is unaware of the allocation of groups.
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
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
Arak University of M
Approval date
2018-02-14, 1396/11/25
Ethics committee reference number
IR.ARAKMU.REC.1396.316
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Sleep quality with Pittsburgh Sleep Quality Questionnaire
Timepoint
Measurement of sleep quality at the beginning of the study and the end of the fourth week after the intervention began
Method of measurement
Pittsburgh Sleep Quality Questionnaire
2
Description
Fatigue with Fatigue Impact Scale MS
Timepoint
Measurement of fatigue at the beginning of the study and the end of the fourth week after the intervention began
Method of measurement
Fatigue Impact Scale MS
3
Description
Anxiety with State-Trait Anxiety Inventory (STAI)
Timepoint
Measurement of anxiety at the beginning of the study and the end of the fourth week after the intervention began
Method of measurement
State-Trait Anxiety Inventory (STAI)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients will undergo 8 reflexology sessions 2 times a week for 4 weeks. Each session is performed for 30 minutes and for each foot for 15 minutes, including 5 minutes for general massage of the foot and 10 minutes for massage on the pituitary glands, hypothalamus, pineal gland on the thumb and continue with massage. On the solar cell will be done.Patient caregiver is given general massage and pressure points to ensure that the correct work is done to ensure patient comfort and comfort due to the difficulty of travel and the cost of reflexology associated with the patient at home. This is done twice a week for 4 weeks and afternoon, and we will be contacted for follow up and reminders with patients and fellows by telephone and SMS.
Category
Treatment - Other
2
Description
Control group: Patients do not receive any reflexology intervention from the researcher. To unify the interventions, the patient is required to take a total of 8 sessions of the supine position twice a week for 4 weeks without pressure for 30 minutes each Touch the feet for 15 minutes. At the end of the eighth session, the same questionnaires will be filled in before the intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Janbazan clinic
Full name of responsible person
Fahimeh Davodabady
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
arjomandzadegan@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
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
Fahimedavodabady@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD