Primary DysmenorrheaNCT03561493
The Effect of Zumba Dance on Primary Dysmenorrhea
A study testing zumba exercise in people with Primary Dysmenorrhea, run by Cairo University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- zumba exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- zumba exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zumba exerciseOther
Also called zumba fittness
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.
| Study group | Role | What they receive |
|---|---|---|
| zumba exercise group | Experimental | 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. Receives: Other: zumba exercise |
| non zumba exercise group | No intervention | The participants in the control group did not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: duration of menses(5-7 days) 1st menstrual cycle.
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.
Measured: duration of menses(5-7 days) 2nd menstrual cycle.
Secondary outcomes (1)
menstrual pain duration
duration of menstrual pain in days will be measured by using descriptive data that will be obtained from study participants.
Measured: 7 days from 1st day of menstruation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start25 Jun 2018 (estimated)
- Primary completion25 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561493
- Sponsor's protocol ID
- zumba exercise
- Status last verified
- Jun 2018
- First submitted
- 11 May 2018
- Last updated
- 19 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zumba Exercise on Menstrual Pain in Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT03561493
- Acronym / sponsor ID
- zumba exercise
- Conditions
- Primary Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jun 2018 (estimated)
- Primary completion
- 25 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zumba exercise group | Experimental | Other: zumba exerciseParticipants 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. |
| non zumba exercise group | No intervention | –The participants in the control group did not receive any intervention. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zumba exerciseAlso: zumba fittnessParticipants 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 | zumba exercise group |
Primary outcome
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.
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.
1 secondary outcome
menstrual pain duration
Time frame: 7 days from 1st day of menstruation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED SAMY, MD principal investigator
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing zumba exercise in people with Primary Dysmenorrhea, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AHMED SAMY, MD (00201100681167, ahmedsamy8233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (time frame: duration of menses(5-7 days) 1st menstrual cycle.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.