Comparison of the effect of reflexology and muscle relaxation on fatigue and anxiety in patients with multiple sclerosis
Design
A single-center double blinded randomized controlled trial, without placebo.
Settings and conduct
This study will be conducted on 105 patients with multiple sclerosis (M.S), at M.S society of Saveh.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Willingness to cooperate in the study and sign the informed consent form; No skin disease with feet involvements; Not having acute infections or ulcer in the feet; 25 to 60 years old patients; No history of taking sedative drugs and no history of psychological problems.
Exclusion criteria: Past year's crisis situations (divorce, death of close relatives and serious accidents).
Intervention groups
First intervention group: in the first intervention group reflexology will be conducted three times a week (each time for 30 minutes) for 4 weeks.
Second intervention group: In this group, the samples will perform the technique of progressive muscle relaxation three times a week (Sundays, Tuesdays and Thursdays) for 4 weeks and each time for 30 to 45 minutes, in the presence of the researcher.
Control group: The samples of the control group will not receive any intervention during this time.
Main outcome variables
Fatigue; Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161210031328N13
Registration date:2021-04-15, 1400/01/26
Registration timing:prospective
Last update:2021-04-15, 1400/01/26
Update count:0
Registration date
2021-04-15, 1400/01/26
Registrant information
Name
Mahbobeh Sajadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
m.sajadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of reflexology and muscle relaxation on fatigue and anxiety in patients with multiple sclerosis
Public title
The effect of reflexology and muscle relaxation on fatigue and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No skin disease with feet involvements.
Not having diabetes with peripheral nerve involvement and sensory disorders in the feet.
Not having acute infections or ulcer in the feet.
25 to 60 years old patients.
No history of taking sedative drugs and no history of psychological problems
Exclusion criteria:
Unwillingness to cooperate in the study.
Past year's crisis situations (divorce, death of close relatives and serious accidents)
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the samples were selected using convenience sampling. To generate the random sequence, permutation block randomization will be used. At first, 6 blocks will constructed as "ABC, ACB, BAC, BCA, CAB, CBA", then these blocks are arranged using a random number table, and individuals will assigned to three groups according to A, B and C letters.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is a double-blinded in which the data analyst and the participants did not know the random allocation.To prevent the transfer of information between the two groups one day is allocated to the intervention and one day to the control group.
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 Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176593
Approval date
2021-02-21, 1399/12/03
Ethics committee reference number
IR.ARAKMU.REC.1399.331
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
Fatigue
ICD-10 code
R53.82
ICD-10 code description
Chronic fatigue, unspecified
Primary outcomes
1
Description
Anxiety score in Spielberger anxiety inventory
Timepoint
Before study and 4 weeks after intervention
Method of measurement
Spielberger anxiety inventory
2
Description
Fatigue score in Smets questionnaire
Timepoint
Before study and 4 weeks after intervention
Method of measurement
Smets multidimensional fatigue inventory
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: in the first intervention group reflexology will be conducted slowly, with a regular rhythm and with a depth of 1 to 3 mm, three times a week (each time for 30 minutes) for 4 weeks.
Category
Treatment - Other
2
Description
Second intervention group: In this group, the samples will perform the technique of progressive muscle relaxation three times a week for 4 weeks and each time for 30 to 45 minutes, in the presence of the researcher.
Category
Treatment - Other
3
Description
Control group: The samples of the control group will receive routine care during this time.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
M.S Society of Saveh
Full name of responsible person
Maliheh Keykavoosi
Street address
M.S Society, Hazrat-e-zahra Blvd., Alavi Town
City
Saveh
Province
Markazi
Postal code
3914858147
Phone
+98 86 4248 2899
Email
m.s_saveh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Deputy of research and technology, Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3505
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
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176593
Phone
+98 86 3417 3505
Email
sajadimahbobeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoud Esmaeili
Position
Masters student of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176593
Phone
+98 86 3417 3505
Email
masoudesmaeily12@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3848176593
Phone
+98 86 3417 3505
Email
sajadimahbobeh@yahoo.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
It is provided unrecognizably at the request of individuals.
When the data will become available and for how long
The access period will start after the results are printed.
To whom data/document is available
Researchers at other Universities are allowed access.
Under which criteria data/document could be used
Documentation is provided in order to know how the work is done and to critique it.
From where data/document is obtainable
Mahbobeh Sajadi
sajadimahbobeh@yahoo.com
What processes are involved for a request to access data/document
After stating the purpose of accessing the information, the requested items will be sent via email.