Objectives: Dysmenorrhea is a common problem among female adolescents. The purpose of this study is to examine the effect of high-frequency transcutaneous electrical nerve stimulation (TENS) on primary dysmenorrhea and to compare the placebo effect by in a randomized controlled study.
Study Design: Sixty –four female aged between 14-18 years at the first day of their menstruation cycle randomly selected in two groups (TENS or placebo TENS). Participants‘ physical characteristics and menstrual history were recorded. Intensities of menstrual pain are measured by self-reported pain intensity using visual analog scale (VAS) before and just after treatment. Paired t-test and independent t-test were conducted to compare pain intensity between pre-post treatment and two groups (TENS vs. placebo).
Results : The decrease of pain intensity after TENS and placebo were examined. َAnd also concurrent use of analgesic was assessed in the both groups.
Conclusions: This result supported that using TENS could be effective in pain reduction among adolescents who were suffered by primary dysmenorrhea.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012072810426N1
Registration date:2015-01-21, 1393/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-21, 1393/11/01
Registrant information
Name
Parisa Parsa
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 4396
Email address
parsa@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medicine and Health Sciences
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2012-10-01, 1391/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Primary Dysmenorrhea in Adolescent girls
Public title
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Primary Dysmenorrhea in Adolescent girls
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterion: having primary dysmenorrhea.
Exclusion criteria: secondary dysmenorrhea or having any plvic mass or abnormal vaginal bleeding.
Age
From 14 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamadan university of Medicine and Health Sciences
Street address
Shahid Fahmideh Street- Counterpoint of Mardom Park- Hamadan university of Medicine and Health Sciences
City
Hamadan
Postal code
65178
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
پ/ 16/ 3/1163
Health conditions studied
1
Description of health condition studied
Primary Dysmenorrhea
ICD-10 code
N.94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Change in pain intencity
Timepoint
After treatment in the two groups
Method of measurement
VAS
Secondary outcomes
1
Description
Reduce in use of pain killer
Timepoint
Two days after treatment
Method of measurement
Check list
Intervention groups
1
Description
In the active group a TENS device (ENRAF NONIUS Model, four electrodes ) with a frequency of 0- 100 and 90-100 pulse /seconds was applied (20 minutes each) respectively, to increase circulation (0-100 pulse/seconds) and to have sedation at the first day of menstrual complaints without taking any analgesics. Patients lied in prone position and a thin pillow placed under their abdomen. Two electrodes were placed to the proximal margin of low back area, and two others were placed to the proximal of gluteal region laterally . The intensity of stimulation was increased up to the tolerated level without leading any contraction .
Category
Treatment - Devices
2
Description
The placebo TENS device had exactly the same appearance as the active TENS, but the placebo TENS had no stimulating output. It was applied for a total of 20 minutes in the prone position to the same regions. Same person provided both active and placebo TENS applications.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medicine and Health Sciences
Full name of responsible person
Dr. Parisa Parsa
Street address
Research Center for Chronic Diseases Home Care . Department of Mother and Child Health, Hamadan University of Medicine and Health Sciences, Hamadan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medicine and Health Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Shahid Fahmideh Street- Counterpoint of Mardom Park-Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medicine and Health 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
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Fahmideh Street -Counterpoin of Mardom Park
City
Hamadan
Postal code
65178-3-8698
Phone
+98 818380051
Fax
Email
parsa@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Center for Chronic Diseases Home Care . Department of Mother and Child Health, Hamadan Univ
Full name of responsible person
Dr.Parisa Parsa
Position
Ph.D
Other areas of specialty/work
Street address
Research Center for Chronic Diseases Home Care . Department of Mother and Child Health, Hamadan University of Medicine and Health Sciences, Hamadan, Iran
City
Hamadan
Postal code
65178-3-8698
Phone
+98 81 3838 0051
Fax
Email
Parsa@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr. Parisa Parsa
Position
PhD
Other areas of specialty/work
Street address
Shahid Fahmideh Street- counterpoint of Mardom Parrk- Faculty of Nursing and Midwifery- Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Phone
+98 918 312 9378
Fax
Email
parsa@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)