Foot reflexology effect on the severity of premenstrual symptoms (Reflex zone therapy) among female university students living in dormitories of Tehran university of medical sciences
The objective of this study was to investigate the foot reflexology effect (Reflex zone therapy) on the severity of premenstrual symptoms among female university students living in dormitories of Tehran University of Medical Sciences. In this single blind randomized clinical trial, 120 female university students, whose PMS were diagnosed by DICKERSON PMS daily record questionnaire for 2 menstrual, were randomly assigned into one of the two study group. One group received a real reflex zone therapy for 8 weeks (once a week for half an hour). The control group received placebo reflex zone therapy using a similar protocol. Physical and mood symptoms were recorded before and after the intervention and the changes were compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012223027N3
Registration date:2011-02-18, 1389/11/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-02-18, 1389/11/29
Registrant information
Name
Fahimeh Sehhatie Shafaie
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
sehhatief@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-01-21, 1388/11/01
Expected recruitment end date
2011-06-21, 1390/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Foot reflexology effect on the severity of premenstrual symptoms (Reflex zone therapy) among female university students living in dormitories of Tehran university of medical sciences
Public title
Foot reflexology effect on the severity of Premenstrual symptom (Reflex zone therapy)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Girls living in student residences, no major underlying diseases, not taking any medication to relieve premenstrual symptom, not to use painkiller during the study, having regular menstrual cycles, not having genital diseases
Exclusion criteria: using hormone drugs, taking antidepressants, having premenstrual symptoms more than 7 day in each cycle, developing tensions and severe psychological crisis within the past few months
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
University St., Tabriz
City
Tabriz
Postal code
Approval date
2010-11-15, 1389/08/24
Ethics committee reference number
8947
Health conditions studied
1
Description of health condition studied
Premenstrual symptom
ICD-10 code
F50, F59
ICD-10 code description
Behavioural syndromes associated with physiological disturbances and physical factors
Primary outcomes
1
Description
physical symptoms of Pms.
Timepoint
2 months before intervention - 2 months after intervention
Method of measurement
Dickerson Standard questionnaire
Secondary outcomes
1
Description
mood symptoms of Pms
Timepoint
2 months before Intervention - 2 months afterl Intervention
Method of measurement
Dickerson Standard questionnaire
Intervention groups
1
Description
real reflex zone therapy for a treatment period of 8 weeks (once a week for half an hour)
Category
Prevention
2
Description
placebo reflex zone therapy for a treatment period of 8 weeks (once a week for half an hour)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Shahid Beheshti Unievrsity of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tabriz university of Medical Sciences
Full name of responsible person
Dr.Rashidi
Street address
University St., Tabriz
City
Tabriz
Grant name
Grant code / Reference number
http://www.tbzmed.ac.ir
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tabriz 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery faculty, Tabriz university of Medical Sciences
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
MS on Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, Tabriz university of Medical Sciences, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
sehhatief@tbzmed.ac.irfahimehsehhatie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reasearch Deputy, Tabriz university of Medical Sciences
Full name of responsible person
Fahimeh Sehhatie Shafaie
Position
MS on Midwifery, Academic member
Other areas of specialty/work
Street address
Nursing and Midwifery faculty, Tabriz university of Medical Sciences, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1479 6770
Fax
Email
sehhatief@tbzmed.ac.irfahimehsehhatie@yahoo.com
Web page address
http://www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)