Back to resultsThe Effect of Zumba Dance on Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
zumba exercise
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
zumba exercise group
non zumba exercise group
Arm Description
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.
The participants in the control group did not receive any intervention.
Outcomes
Primary Outcome Measures
Intensity of pain
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.
Intensity of pain
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.
Secondary Outcome Measures
menstrual pain duration
duration of menstrual pain in days will be measured by using descriptive data that will be obtained from study participants.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03561493
Brief Title
The Effect of Zumba Dance on Primary Dysmenorrhea
Official Title
Effect of Zumba Exercise on Menstrual Pain in Women With Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 25, 2018 (Anticipated)
Primary Completion Date
September 25, 2018 (Anticipated)
Study Completion Date
September 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
the objective of this study is to investigate the effect of practising Zumba exercise in decreasing menstrual pain in young women with primary dysmenorrhea.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
zumba exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
non zumba exercise group
Arm Type
No Intervention
Arm Description
The participants in the control group did not receive any intervention.
Intervention Type
Other
Intervention Name(s)
zumba exercise
Other Intervention Name(s)
zumba fittness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intensity of pain
Description
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.
Time Frame
duration of menses(5-7 days) 1st menstrual cycle.
Title
Intensity of pain
Description
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.
Time Frame
duration of menses(5-7 days) 2nd menstrual cycle.
Secondary Outcome Measure Information:
Title
menstrual pain duration
Description
duration of menstrual pain in days will be measured by using descriptive data that will be obtained from study participants.
Time Frame
7 days from 1st day of menstruation).
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AHMED SAMY, MD
Phone
00201100681167
Email
ahmedsamy8233@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED SAMY, MD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Effect of Zumba Dance on Primary Dysmenorrhea
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