Women's Health: EndometriosisNCT03586804
Postural Sway at Menstrual Cyclus
An observational study of Women's Health: Endometriosis, run by Hacettepe University.
Trial summary
The study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome. Women will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Women's Health: Endometriosis
- What is being tested?
- dual task
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2018to 30 Oct 2018
- Phase
- Observational
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with and without pain at menstrual cycles
Who may be able to join
- Have dysmenorrheal syndrome
- Have menstrual cycle without pain
Who cannot join
- Have another health problem (systemic, neurologic, orthopedic or psychiatric)
About this study
Official title: Comparison of Postural Sway Responses at Menstrual Cyclus in Women With and Without Dysmenorrheal Syndrome
The study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome.
Women will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Every participant will be evaluated same tool. They will be assessed for three times at every session: 1st evaluation will be performed at the normal standing position. 2nd evaluation will be performed at the normal standing position while individuals saying the numbers from 200 to 1. 3rd evaluation will be performed at the normal standing position while individuals holding the mini blocks on their hands.
Read the detailed description
The study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome.
Women will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Every participant will be evaluated with the same tool. They will be assessed for three times at every session: 1st evaluation will be performed at the normal standing position. 2nd evaluation will be performed at the normal standing position while individuals saying the numbers from 200 to 1. 3rd evaluation will be performed at the normal standing position while individuals holding the mini blocks on their hands.
Results will be compared for menstrual cycles and well-being day in women with and without pain at menstrual cycles.
- Conditions
- Women's Health: Endometriosis
- Being tested
- dual task
- Keywords
- menstrual, postural sway, dual task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual taskOther
mental and motor tasks will be performed while standing. Motor task: holding mini blocks Mental task: Counting the numbers from 200 to 1
| Study group | Role | What they receive |
|---|---|---|
| women without dysmenorrheal syndrome | women without dysmenorrheal syndrome Receives: Other: dual task | |
| women with dysmenorrheal syndrome | women with dysmenorrheal syndrome Receives: Other: dual task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Postural sway score
Postural sway is a swing of the body while a person is standing in upright position.
Measured: First evaluation: at first minute. Second evauation: Change baseline postural sway score at 15th minutes. Third evaluation: Change baseline postural sway score at 30th minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start30 Jul 2018 (estimated)
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's Health: EndometriosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hhotaman, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586804
- Sponsor's protocol ID
- TU-216
- Status last verified
- Jul 2018
- First submitted
- 6 Jul 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postural Sway Responses at Menstrual Cyclus in Women With and Without Dysmenorrheal Syndrome
- ClinicalTrials.gov ID
- NCT03586804
- Acronym / sponsor ID
- TU-216
- Conditions
- Women's Health: Endometriosis
- Keywords
- menstrual, postural sway, dual task
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Jul 2018 (estimated)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 16 Jul 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 study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome.
Women will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Every participant will be evaluated same tool. They will be assessed for three times at every session: 1st evaluation will be performed at the normal standing position. 2nd evaluation will be performed at the normal standing position while individuals saying the numbers from 200 to 1. 3rd evaluation will be performed at the normal standing position while individuals holding the mini blocks on their hands.
Detailed description
The study was planned with the aim of comparison of postural sway responses at menstrual cycles in women with and without the dysmenorrheal syndrome.
Women will stand on a postural sway evaluation system on the first day of the menstrual cycles and a well-being day which they will select. Every participant will be evaluated with the same tool. They will be assessed for three times at every session: 1st evaluation will be performed at the normal standing position. 2nd evaluation will be performed at the normal standing position while individuals saying the numbers from 200 to 1. 3rd evaluation will be performed at the normal standing position while individuals holding the mini blocks on their hands.
Results will be compared for menstrual cycles and well-being day in women with and without pain at menstrual cycles.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women without dysmenorrheal syndrome | – | Other: dual taskwomen without dysmenorrheal syndrome |
| women with dysmenorrheal syndrome | – | Other: dual taskwomen with dysmenorrheal syndrome |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with and without pain at menstrual cycles
Key inclusion criteria (2 listed)
- Have dysmenorrheal syndrome
- Have menstrual cycle without pain
Key exclusion criteria (1 listed)
- Have another health problem (systemic, neurologic, orthopedic or psychiatric)
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 |
|---|---|---|
| dual taskmental and motor tasks will be performed while standing. Motor task: holding mini blocks Mental task: Counting the numbers from 200 to 1 | Other | women with dysmenorrheal syndrome, women without dysmenorrheal syndrome |
Primary outcome
Change of Postural sway score
Time frame: First evaluation: at first minute. Second evauation: Change baseline postural sway score at 15th minutes. Third evaluation: Change baseline postural sway score at 30th minutes.
Postural sway is a swing of the body while a person is standing in upright position.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Women's Health: Endometriosis, run by Hacettepe 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 2 inclusion and 1 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 16 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Postural sway score (time frame: First evaluation: at first minute. Second evauation: Change baseline postural sway score at 15th minutes. Third evaluation: Change baseline postural sway score at 30th minutes.). 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 16 Jul 2018.