General objective: Comparison the effect of moxibustion & acupressure at the point sp6 on the severity of dysmenorrhea in female students residing in dormitories of Islamic Azad University of Sabzevar in 2015. Design of the study: Methods of study: A) The study population: all female students of primary dysmenorrhea residing in dormitories of Islamic Azad University of Sabzevar in 2015. Study Sample: all female students residing in dormitories of Islamic Azad University of Sabzevar in 2015; goups: moxibustion and acupressure; Sample size: 100; Randomized. Setting and conduct: clinical trial; Inclusion criteria: being single; age between 18 – 25 year old; girls with primary dysmenorrhea that the pain intensity as moderate to severe based McGill ruler; do not suffering from chronic diseases (diabetes, hypertension, cardiac diseases, infectious diseases, liver, kidney); regular menstruation (period between 21 – 35 days); have not any symptoms of itching, abnormal discharge during study; the absence of ulcer, varicose, cutaneous and inflammatory diseases at the point sp6. Exclusion criteria: individual's consent to continue participating in the study; pelvic known pathology(myoma, pelvic tumor, endometriosis, PID) during the study; improper use of moxibustion & acupressure; any use of herbal drug during the study; Sensitivity to moxa. Intervention in study: use moxibustion & acupressure; Intervention duration: Twice with an interval of 48 hours before their bleeding and 2 first day of bleeding. The primary outcome: reduce primary dysmenorrheal after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505236807N17
Registration date:2015-08-04, 1394/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-04, 1394/05/13
Registrant information
Name
Sedigheh Amir Ali Akbari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9240
Email address
akbarisedd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The International Branch of Shahid Beheshti University of Medical Sciences& Health Services
Expected recruitment start date
2015-02-14, 1393/11/25
Expected recruitment end date
2015-06-15, 1394/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of moxibustion & acupressure at the point sp6 on severity of primary dysmenorrhea
Public title
Comparison the effect of moxibustion & acupressure on severity of menstrual pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being single; age between 18 – 25 year old; girls with primary dysmenorrhea that the pain intensity as moderate to severe based McGill ruler; do not suffering from chronic diseases (diabetes, hypertension, cardiac diseases, infectious diseases, liver, kidney); regular menstruation (period between 21 – 35 days); have not any symptoms of itching, abnormal discharge during study; not taking any medication, supplements; they should not use any herbal remedies about 3 months ago Intervention; they should not have any deplorable event such as near relatives’ death or surgical operation in recent six months; the absence of ulcer, varicose, cutaneous and inflammatory diseases at the point sp6. Exclusion criteria: individual's consent to continue participating in the study; pelvic known pathology(myoma, pelvic tumor, endometriosis, PID) during the study; improper use of moxibustion & acupressure; any use of herbal drug during the study; Sensitivity to moxa.
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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
The International Branch of Shahid Beheshti University of Medical Sciences& Health Services
Street address
Shaid Beheshti University of Medical Sciences, next to Tavanir, Abbas pur Street, Valiasr Street
City
Tehran
Postal code
Approval date
2015-01-19, 1393/10/29
Ethics committee reference number
1000/2581
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Severity of primary dysmenorrhea
Timepoint
Before the intervention, while following intervention during the 3 first day of bleeding in 2 cycles.
Method of measurement
Verbal Multidimensional Scoring System Questionnaire, McGill ruler.
Secondary outcomes
1
Description
Complications
Timepoint
Finally of bleeding days
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group1: in people with inclusion criteria To be attached moxa burning for 10 minutes,( twice with an interval of 48 hours, 4-5 days before their bleeding and 2 first day of bleeding) during 2 cycles. pain intensity with Systemic characteristics associated Will be recorded using McGill and verbal multidimensional scoring system.
Category
Treatment - Other
2
Description
Intervention group2: in people with inclusion criteria To be acupressure at sp6 points for 10 minute on each feet, ( twice with an interval of 48 hours, 4-5 days before their bleeding and 2 first day of bleeding) during 2 cycles. pain intensity with Systemic characteristics associated Will be recorded using McGill and Verbal Multidimensional Scoring System.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University girl's Kosar dormitory of Islamic Azad University of Sabzevar
Full name of responsible person
Yaghobinezhad Azam
Street address
Daneshgah Street, Pasdaran Boulevard, Doctor Shariati Square
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The International Branch of Shahid Beheshti University of Medical Sciences& Health Services
Full name of responsible person
Dr. Masoumeh Simbar
Street address
Shaid Beheshti University of Medical Sciences, next to Tavanir, Abbas pur Street, Valiasr Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The International Branch of Shahid Beheshti University of Medical Sciences& Health Services
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
Shaid Beheshti University of Medical Sciences
Full name of responsible person
Sedigheh Amir Ali Akbari
Position
MSc in midwifery
Other areas of specialty/work
Street address
Midwifery group, School of Nursing and Midwifery Shahid Beheshtii, Front Rajai Heart Hospital, Highway intersection niayesh, Valiasr street
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
Email
sedaliakbari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaid Beheshti University of Medical Sciences
Full name of responsible person
Sedigheh Amir Ali Akbari
Position
MSc in midwifery of Shaid Beheshti University of Medical sciences
Other areas of specialty/work
Street address
Midwifery group, School of Nursing and Midwifery Shahid Beheshtii, Front Rajai Heart Hospital, Highway intersection niayesh, Valiasr street
City
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Fax
Email
sedaliakbari@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)