This study is a single-blind randomized clinical trial that is done on 75 patients with multiple sclerosis referred to MS clinic of Ayatollah Kashani Hospital. After simple non-random sampling, participants were randomly assigned by minimization method to three groups: reflexology (25patients), relaxation (25 patients) and control (25 patients). In the experimental groups was performed foot reflexology and relaxation intervention (Jacobson and Benson) within 4 weeks, twice a week for 40 minutes and the control group were received only routine medical treatment as directed by a doctor. Data was collected via Demographic information questionnaire, fatigue severity scale (FSS), numerical pain scale (NRS) and questionnaire (DASS-21), before, immediately after and two months after interventions in all three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050117387N2
Registration date:2014-07-01, 1393/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-01, 1393/04/10
Registrant information
Name
Fatemeh Nazari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7589
Email address
nazari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-06-09, 1392/03/19
Expected recruitment end date
2013-08-21, 1392/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of reflexology and relaxation on physical and mental symptoms in women with multiple sclerosis
Public title
Compare the effects of reflexology and relaxation on physical and mental symptom multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Women aged 18-50 years suffering from MS (relapsing-remitting, primary progressive and secondary progressive); MS final diagnosis by neurologists based on McDonald criteria with the elapse of at least 6 months from relevant diagnosis; tendency to participate in the research; no previous participation at treatment sessions of complementary medicine methods such as reflexology, relaxation, massage for the last 6 months; to feel chronic pain in at least one body organs, previous use of pain medication and Numerical Rating Scale (NRS); having the fatigue severity score of equal to and over 4 based on fatigue severity scale( FSS); have high scores of depression (more than 13), anxiety (more than 9) and stress (more than 18) based on DASS-21 scale; acquisition of scores 0-5.5 based on the Expanded Disability Status Scale( EDSS); not being in the menstruation period, nonexistence of deformity, callus or corn in the feet, feet lesion or cleft, active thrombosis or phlebitis, Varicose veins, record of latest ankle trauma, sprain, fracture, feet palm inflammation or infection; no affliction with diseases other than MS such as febrile acute or bodily chronic (flu, cardiac disabling, glands, respiratory, hepatic, skeletomuscular, renal), mental or psychic disorders such as severe depression, speech or hearing disorder; no addiction to narcotics and psychotropic; not being a member to the treatment crew (physician, nurse); to feel chronic pain in at least one body organs; previous use of pain medication and Numerical Rating Scale (NRS) pain score more 4 for at least 6 months; no pregnancy or no willingness to be pregnant and after taking of informed written consent. Exclusion criteria: No wanting to continue cooperation in research, use another CAM either current; absence of more than two session's acute relapse of the disease one month preceding ordering the study period or within study
.
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences.Hezar Jerib st, ,Isfahan, Iran
City
Isfahan
Postal code
Approval date
2013-05-06, 1392/02/16
Ethics committee reference number
392094
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
Physical symptoms (pain,fatigue)
Timepoint
Before, immediately and two months after interventions
Method of measurement
Questionnaire
2
Description
Mmental symptoms (stress ,anexity , depression)
Timepoint
Before, immediately and two months after interventions
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the experimental groups were performed foot reflexology and relaxation intervention (Jacobson and Benson) within 4 weeks, twice a week for 40 minutes
Category
Treatment - Other
2
Description
The control group was received only care and routine medical treatment as directed by a doctor.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
MS clinic of Ayatollah Kashani Hospital in Isfahan.
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy Isfahan University of Medical Sciences
Full name of responsible person
Fateme Nazari
Street address
Isfahan University of Medical Sciences, Hezar Jerib st, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fateme Nazari
Position
MSc Nursing, Faculty member, School of Nursing and Midwifery
Other areas of specialty/work
Street address
Hezar Jerib st,Isfahan University of Medical Sciences ,Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1792 2948
Fax
Email
nazari@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fateme Nazari
Position
MSc Nursing
Other areas of specialty/work
Street address
Hezar Jerib st, Isfahan University of Medical Sciences,Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1792 2948
Fax
Email
nazari@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fateme Nazari
Position
Other areas of specialty/work
Street address
City
Isfahan
Postal code
Phone
+98 31 1792 2948
Fax
Email
nazari@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)