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The effect of foot reflexology on premenstrual syndrome among students in the dormitory of jahrom university 1390

Protocol summary

Summary
This study determined the effects of foot reflexology on symptoms of premenstrual syndrome on students living in dormitories are Jahrom University, and the prevalence of disease, and selection of samples based on inclusion criteria: age 35-18 years, normal BMI, lack of drug addiction, smoking and alcohol, regular menstrual periods, lack of physical and mental illness and exclusion criteria included shock and misadventure and drug use that affect the PMS, as patients with premenstrual syndrome randomized into two groups. In the intervention group were treated by the researcher with foot reflexology, foot reflexology for 15 minutes on each leg (total 30 minutes) once a day, 10-5 days prior to the time period (monthly bleeding cycle) is , and it is before the onset of symptoms, and be continued until the period (total 10-5 days). Just a gentle massage and foot controls are ineffective. Independent variable and the dependent variable in this study, foot reflexology is the study of premenstrual syndrome.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811103226N1
Registration date: 2012-08-07, 1391/05/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-08-07, 1391/05/17
Registrant information
Name
Mahrokh Dolatian
Name of organization / entity
Shahid Beheshti University of Medical Scenices
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
m_dolatian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Scineces
Expected recruitment start date
2011-12-21, 1390/09/30
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on premenstrual syndrome among students in the dormitory of jahrom university 1390
Public title
The effect of reflexology on premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian race; 18 – 35 year age; normal BMI (19.8 – 26); not addicted to drugs, cigarette and alcohol; regular menstruation (Period between 21 – 35 days); gained score 0 – 9 in Depression Test. By virtue of their own statements they should not have known mental disease such as bipolar and personality disorders, drugs misuse and other mental diseases and depression. Also they should have the syndrome according to the table registering daily signs for two months. They should not use vitamins ( B6, E , sulfate zinc , multivitamin ), contraceptives , medroxyprogesterone, diderogestrone, spironolactone , fluexetine , alperazolam , calcium , anticonvulsive , antidepressive and herbal medications in recent three months or any drugs influencing on the premenstrual syndrome( PMS). They should not have had any deplorable event such as near relatives’ death or surgical operation in recent six months. Exclusion criteria: known physical disease; suffering from cardiac diseases; coagulation disorders; deep vein thrombosis; vein phlebitis, infection; feet burn or wound and severe infections; diabetes; heartbeat regulation apparatus and varicose vein and If the patients do not cooperate.
Age
From 18 years old to 35 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 90
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
The International Branch of Shahid Beheshti university of medical sciences & health sciences
Street address
Shahid Abbaspoor avenue, Tavanir avenue, nabshe pol hemmat, the international branch of shahid beheshti university of medical sciences & health sciences
City
Tehran
Postal code
Approval date
2011-11-29, 1390/09/08
Ethics committee reference number
116/3540

Health conditions studied

1

Description of health condition studied
Premenstrual Syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
Foot Reflexology
Timepoint
5-10 days before mensturation period
Method of measurement
Check List

Secondary outcomes

1

Description
Prementrual Syndrome
Timepoint
Prementrual Syndromeforms have been completed by sampel of this study for 2 months
Method of measurement
Prementrual Syndrome Questinnare daily,DSM4

Intervention groups

1

Description
Foot reflexology for 15 minutes on each leg (total 30 minutes) once a day, 10-5 days prior to the time period (monthly bleeding cycle) is, and it is before the onset of symptoms, and the time period be continued (total 10-5 days (
Category
Treatment - Other

2

Description
In the control group (without doing foot reflexology techniques) in those days, ie 5-10 days before menstruation and gentle massage to the feet may be ineffective.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
The Girls Students Dormitory of Jahrom University
Full name of responsible person
Sareh Abdollahy fard
Street address
the dormitory of jahrom university(nomber 1-11),sepah avenue,jahrom city,fars state
City
Jahrom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Intrnational Branch of Medical Science & Health medicine Shahid Beheshti University
Full name of responsible person
Mrs Dr Ghanati
Street address
The intrnational branch of medical science & health medicine Shahid Beheshti university,Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Intrnational Branch of Medical Science & Health medicine Shahid Beheshti University
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
Shahid Beheshti University of Medical Sciences, International-Branch, Iran.
Full name of responsible person
Sareh Abdollahifard
Position
M.Sc Student of Midwifery
Other areas of specialty/work
Street address
Vali Asr niayesh avenue,Nursing & Midwifery college of Shahid Beheshti University of Medical Sciences,Tehran
City
Tehran
Postal code
7413934358
Phone
+98 21 8820 2512
Fax
Email
sareh_abdollahyfard@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, International-Branch, Iran.
Full name of responsible person
Sareh Abdollahifard
Position
M.Sc Student of Midwifery
Other areas of specialty/work
Street address
Vali Asr-niayesh avenue,Shahid Beheshti University of Medical Sciences, International,nursing &midwifery college,Tehran
City
Tehran
Postal code
7413934358
Phone
+98 21 8820 2512
Fax
Email
sareh_abdollahyfard@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
The Intrnational Branch of Medical science & health medicine Shahid Beheshti university
Full name of responsible person
Sareh Abdollahi fard
Position
Ms student of Midwifery
Other areas of specialty/work
Street address
The intrnational branch of medical science & health medicine Shahid Beheshti university,Tehran
City
Tehran
Postal code
7413934358
Phone
+98 21 8820 2512
Fax
Email
sareh_abdollahyfard@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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