Protocol summary

Summary
The aim of this study was to investigate the effect of heat and vibration on primary dysmenorrhea ‎among students of Gorgan Islamic Azad University. In this clinical trial 75 female students, aged 18-22 years old from Gorgan Islamic Azad ‎University, participated. Each subject evaluated for two menstrual cycles. At first cycle the participants received the routine pain-relief method. At the second cycle each of them applied combined heat-vibration device for ten minutes during ‎menstrual pain. The data collected using ‎questionnaire and pain Visual Analog Scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102195866N1
Registration date: 2011-10-10, 1390/07/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-10, 1390/07/18
Registrant information
Name
Akram Sanagoo
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
sanagoo@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Young researchers club, Science and Research Brach, Islamic Azad University
Expected recruitment start date
2007-10-10, 1386/07/18
Expected recruitment end date
2008-06-10, 1387/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of heat and vibration on primary dysmenorrhea ‎among students of Gorgan Islamic Azad University
Public title
The effect of heat and vibration on primary dysmenorrhea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having dysmenorrhea Exclusion criteria: Cardiovascular disease, severe Anemia, chronic headache, previous pelvic surgery, secondary dysmenorrhea and marriage
Age
From 9 years old to 50 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences
City
Gorgan
Postal code
Approval date
2007-08-23, 1386/06/01
Ethics committee reference number
23-6-86 پ م 941

Health conditions studied

1

Description of health condition studied
Dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea

Primary outcomes

1

Description
Pain intensity
Timepoint
Monthly
Method of measurement
Pain Mesurment Ruler

Secondary outcomes

empty

Intervention groups

1

Description
At the second cycle each of them applied combined heat-vibration device for ten minutes during ‎menstrual pain.
Category
Treatment - Devices

2

Description
No intervention at first menstural cycle
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Gorgan Azad University
Full name of responsible person
Akram Sanagoo
Street address
Golestan University of Medical Sciences, Bouyeh School of Nursing & midwifery, Shastkola Road, Gorgan,
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Young researchers club, Science and Research Brach Islamic Azad University
Full name of responsible person
Dr Akram Sanagoo
Street address
Young researchers Club,Science and Research Brach Islamic Azad University
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Young researchers club, Science and Research Brach Islamic Azad 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
Golestan University of Medical Sciences
Full name of responsible person
Akram Sanagoo
Position
Faculty member
Other areas of specialty/work
Street address
Golestan University of Medical Science, Shastkola, Gorgan
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
sanagoo@goums.ac.ir
Web page address
www.goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan university of Medical Sciences
Full name of responsible person
Akram Sanagoo
Position
Faculty member
Other areas of specialty/work
Street address
Golestan university of medical sciences,shastkhola, gorgan,iran
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
sanagoo@goums.ac.ir
Web page address
www.goums.ac.ir

Person responsible for updating data

Contact

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
empty
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