The aim of this randomize control trial is comparison effect of massage therapy and isometric exercise on primary dysmenorrhea in student of dormitories Shiraz university.96 females with primary dysmenorrhea will be selected and will be randomly put in three group; massage therapy, isometric exercise and control .Inclusion criteria: female student with intensity of pain 5 or more by Visual Analogue Scale (VAS), any systemic or reproductive organ disease; exclusion criteria: use of analgesic drug during study, allergy to lavender oil, more than 3 hours of continuous exercise per week. Massage therapy group after the start of dysmenorrhea will receive 30 minute massage of the upper symphysis pubis and upper umbilicus. Pain will be measured before and after massage with Visual Analogue Scale (VAS), and anxiety will be measured at 24 hours after massage. Exercise group will take isometric exercise protocol for 8 weeks. In control group will not be any intervention. Pain in control and exercise group will be measured in first and second day start of dysmenorrhea before and after 30 minute. Anxiety levels will be measured 24 hours after pain on second day
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012123011945N1
Registration date:2013-03-12, 1391/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-03-12, 1391/12/22
Registrant information
Name
Hajar Rajaei bakhshayesh
Name of organization / entity
Fatemeh college of nursing and midwifery, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1212 2633
Email address
rajaei_h@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Shiraz University of Medical Sciences
Expected recruitment start date
2012-10-21, 1391/07/30
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of massage therapy and isometric exercises on primary dysmenorrhea
Public title
comparison of massage and isometric exercise on dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria:female student with intensity of pain is 5 or more by VAS;any systemic or reproductive organ diseases; exclusion criteria:use of analgesic drug during study;any allergy to lavender oil;more than 3 hours of continuous per week
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
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
Shiraz University of Medical Sciences
Street address
Zand ave
City
Shiraz
Postal code
Iran
Approval date
2012-12-24, 1391/10/04
Ethics committee reference number
CT-91-6355
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Pain duration and severity
Timepoint
First, second and third months.
Method of measurement
visoual analogue scale
Secondary outcomes
1
Description
anexitey
Timepoint
First, second and third months.
Method of measurement
Spiel berger questionnaire
Intervention groups
1
Description
In massage therapy group ,take massage upper symphysis pubis and upper umbilicus for tow month .
Category
Other
2
Description
In Exercise group ,training isometric exercise protocol for 8 weeks.
Category
Other
3
Description
In control group not be any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Eram Dormitories, Shiraz University
Full name of responsible person
Leyla Hatamy
Street address
Eram Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Hatam
Street address
Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
Sara Azima
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi Sq.
City
Shiraz
Postal code
Phone
+98 71 1647 4253
Fax
Email
azimas@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
Sara Azima
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi Sq.
City
Shiraz
Postal code
Phone
+98 71 1647 4257
Fax
Email
azimas@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
Sara Azima
Position
Master's degree in Midwifery, Faculty member
Other areas of specialty/work
Street address
Namazi Sq.
City
Shiraz
Postal code
Phone
00
Fax
Email
azimas@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)