- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03561493
The Effect of Zumba Dance on Primary Dysmenorrhea
June 7, 2018 updated by: Ahmed Samy aly ashour, Cairo University
Effect of Zumba Exercise on Menstrual Pain in Women With Primary Dysmenorrhea
the objective of this study is to investigate the effect of practising Zumba exercise in decreasing menstrual pain in young women with primary dysmenorrhea.
Study Overview
Detailed Description
primary dysmenorrhea or painful menstruation without pelvic pathology is one of the most common complaints in women's medicine.
The pain begins with the onset of menstrual bleeding and lasts for 72-12 h.
Pain is usually in the middle line of the highest severity.
Dysmenorrhea pain is often described as cramped and intermittent.
Zumba is a dance-based fitness class that originated in Colombia in the 1990s and is now extremely popular worldwide.
the aim of this study is to investigate the effect of 8 weeks of regular Zumba exercise on the severity of primary dysmenorrhea.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- having regular menstrual cycles (30-35 days) and bleeding time of 3-10 days.
- history of primary dysmenorrhea(PD) which had affected daily activities in at least 50% of their cycles through the past 6 months; and pain intensity over 4 cm, based on the 10-cm visual analog scale score.
- having a pain score for PD on the visual analog scale (VAS) of 4-7 cm
- Age: 18-25 years.
Exclusion Criteria:
- Pregnancy
- known diseases of the genitourinary system (e.g., pelvic inflammatory disease and urinary tract infections) or secondary dysmenorrhea and chronic diseases (heart disease, respiratory, kidney, blood pressure, asthma, diabetes, epilepsy, migraine, thyroid, anemia, nervous disorders).
- Previous Zumba fitness practice.
- irregular menstrual cycles; the use of intra-uterine devices and oral contraceptive pills.
- musculoskeletal injuries and metabolic/cardiorespiratory contraindications to physical exercise
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: zumba exercise group
Participants will engage in 16 classes of 60-minute Zumba® fitness for two consecutive menstrual cycles (an 8-week period, twice weekly).
Each class was one h in length and a recovery period of at least 48 h was taken between classes.
|
Participants will engage in 16 classes of 60-minute Zumba® fitness for two consecutive menstrual cycles (an 8-week period, twice weekly).
Each class was one hour in length and a recovery period of at least 48 h was taken between classes.
Each session will be initiated with low-intensity movements for the first 5 min, followed by an increasing intensity throughout the workout.
At the end of the training session, the intensity will be gradually reduced.
The Zumba sessions will be supervised by three certified Zumba instructors, each responsible for regular sessions per week.
Other Names:
|
No Intervention: non zumba exercise group
The participants in the control group did not receive any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intensity of pain
Time Frame: duration of menses(5-7 days) 1st menstrual cycle.
|
Pain intensity will be measured by using a 10-point visual analog scale(VAS) in which a line was calibrated from 0 to 10 with 0 representing ''no pain at all''and 10 representing ''worst pain possible.''
Participants will indicate their perceived pain levels by pointing to the appropriate value on a 10-cm horizontal ruler.
The intensity of pain will be rated to the first decimal place in centimeters.Higher scores represent higher menstrual pain intensity.
|
duration of menses(5-7 days) 1st menstrual cycle.
|
Intensity of pain
Time Frame: duration of menses(5-7 days) 2nd menstrual cycle.
|
Pain intensity will be measured by using a 10-point visual analog scale(VAS) in which a line was calibrated from 0 to 10 with 0 representing ''no pain at all''and 10 representing ''worst pain possible.''
Participants will indicate their perceived pain levels by pointing to the appropriate value on a 10-cm horizontal ruler.
The intensity of pain will be rated to the first decimal place in centimeters.Higher scores represent higher menstrual pain intensity.
|
duration of menses(5-7 days) 2nd menstrual cycle.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
menstrual pain duration
Time Frame: 7 days from 1st day of menstruation).
|
duration of menstrual pain in days will be measured by using descriptive data that will be obtained from study participants.
|
7 days from 1st day of menstruation).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 25, 2018
Primary Completion (Anticipated)
September 25, 2018
Study Completion (Anticipated)
September 30, 2018
Study Registration Dates
First Submitted
May 11, 2018
First Submitted That Met QC Criteria
June 7, 2018
First Posted (Actual)
June 19, 2018
Study Record Updates
Last Update Posted (Actual)
June 19, 2018
Last Update Submitted That Met QC Criteria
June 7, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- zumba exercise
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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