Back to resultsImpacts of Static Magnetic Fields on Dysmenorrhea Pain
Primary Purpose
Period Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnet
Sponsored by
About this trial
This is an interventional treatment trial for Period Pain
Eligibility Criteria
Inclusion Criteria: Female with period pain score consistently equal to or greater than 6 on a pain scale of 0-10 -
Exclusion Criteria:
- Pain not experienced on almost all menstrual cycles
- Having secondary dysmenorrhea including endometriosis, fibroids or pelvic inflammatory disease
- Having a pacemaker or any implanted wires or devices -
Sites / Locations
- Nova Southeastern University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Magnet group
Sham group
Arm Description
Women wearing magnet a magnet, or sham device indistinguishable from the magnet (determined randomly), will be placed on her abdomen. If the pain is predominately in her abdomen, the device will be placed on the location with the most pain. If the pain is predominantly in the subjects back, the device will be placed on the lower abdomen on the midline between the umbilicus and the pubic bone.
Women wearing sham a magnet, or sham device indistinguishable from the magnet (determined randomly), will be placed on her abdomen. If the pain is predominately in her abdomen, the device will be placed on the location with the most pain. If the pain is predominantly in the subjects back, the device will be placed on the lower abdomen on the midline between the umbilicus and the pubic bone.
Outcomes
Primary Outcome Measures
Pain score scale of 1-10 / 1 being less pain 10 being more pain
Subject reported pain after wearing device
Secondary Outcome Measures
Full Information
NCT ID
NCT04539691
First Posted
August 31, 2020
Last Updated
June 24, 2021
Sponsor
Nova Southeastern University
1. Study Identification
Unique Protocol Identification Number
NCT04539691
Brief Title
Impacts of Static Magnetic Fields on Dysmenorrhea Pain
Official Title
Impacts of Static Magnetic Fields on Dysmenorrhea Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
March 8, 2021 (Actual)
Study Completion Date
March 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nova Southeastern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Study to determine the effectiveness of a certain type of magnet to reduce period pain
Detailed Description
Young women with their period pain levels of 6 or greater on a pain scale of 0-10 will wear a concentric magnet or a sham that is positioned close to the maximum pain site. The pain score after wearing either the magnet or sham will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Period Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Magnet and sham devices used weigh and look the same
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnet group
Arm Type
Experimental
Arm Description
Women wearing magnet
a magnet, or sham device indistinguishable from the magnet (determined randomly), will be placed on her abdomen. If the pain is predominately in her abdomen, the device will be placed on the location with the most pain. If the pain is predominantly in the subjects back, the device will be placed on the lower abdomen on the midline between the umbilicus and the pubic bone.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
Women wearing sham
a magnet, or sham device indistinguishable from the magnet (determined randomly), will be placed on her abdomen. If the pain is predominately in her abdomen, the device will be placed on the location with the most pain. If the pain is predominantly in the subjects back, the device will be placed on the lower abdomen on the midline between the umbilicus and the pubic bone.
Intervention Type
Device
Intervention Name(s)
Magnet
Intervention Description
Magnet or Sham is worn by subject in close proximity to their described maximum pain site
Primary Outcome Measure Information:
Title
Pain score scale of 1-10 / 1 being less pain 10 being more pain
Description
Subject reported pain after wearing device
Time Frame
40 minutes
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Ages 18-35 years of age with period pain score consistently equal to or greater than 6 on a pain scale of 0-10
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female with period pain score consistently equal to or greater than 6 on a pain scale of 0-10 -
Exclusion Criteria:
Pain not experienced on almost all menstrual cycles
Having secondary dysmenorrhea including endometriosis, fibroids or pelvic inflammatory disease
Having a pacemaker or any implanted wires or devices -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harvey Mayrovitz, PhD
Organizational Affiliation
Nova Southeastern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nova Southeastern University
City
Davie
State/Province
Florida
ZIP/Postal Code
33328
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Impacts of Static Magnetic Fields on Dysmenorrhea Pain
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