The purpose of this study is to survey Reflexology on depression during menopause.
Design
Clinical trial has two groups of control, based on two groups of intervention and examination. The crash is done through the software. The sample size is 90 to. The phase of clinical trial is intervention.
Settings and conduct
A sample of 90 subjects who have entered the study and who are referring to Health Center Glabchi will be in control and test groups.Doing of intervention is that foot reflexology massage is done for 15 minutes per foot in the test group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: have depression; have not skin decease in the leg ; have complete satisfaction to participate in the study; have Score 14 or higher than the Beck scale of the pain; .Conditions of failure to enter : using antidepressant drugs during the study; unwilling to participate in the study;
Intervention groups
Reflexology will perform two days a week for 8 weeks in intervention and nothing in control group
Main outcome variables
Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111210008348N38
Registration date:2018-07-24, 1397/05/02
Registration timing:registered_while_recruiting
Last update:2018-07-24, 1397/05/02
Update count:0
Registration date
2018-07-24, 1397/05/02
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-12, 1397/03/22
Expected recruitment end date
2018-10-14, 1397/07/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Reflexology on Depression During Menopause
Public title
Effect of Reflexology on Depression During Menopause
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have Literacy
Have Depression
Have Complete Satisfaction to participate in the study
Have a Score higher than 14 of the Beck Depression Scale
Exclusion criteria:
Use of other Complementary therapies
Having Acute Infections
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of test and Control groups is done using quadratic random blocks method using software
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 Kashan University of Medical Sciences
Street address
Kashan,Ravand Street,Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2018-05-31, 1397/03/10
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1397.011
Health conditions studied
1
Description of health condition studied
Reflexology
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures
Primary outcomes
1
Description
Depression
Timepoint
Before,After and 2 month After intervention
Method of measurement
Beck questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group, Reflexology will perform two day a week for 6 weeks.
Category
Treatment - Other
2
Description
Control group: in the Control group, no intervention will not perform during 6 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Glabch Health Center
Full name of responsible person
Neda Mirbagher
Street address
Kashan,Ghadir street,Glabch Health Center
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Street address
Kashan,Ravand Street,Kashan University Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan,RavandStreet,Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan,Ravand street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashan,Ravand Street,Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.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