NCT03586804

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

July 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

2 months

First QC Date

July 6, 2018

Last Update Submit

July 12, 2018

Conditions

Keywords

menstrualpostural swaydual task

Outcome Measures

Primary Outcomes (1)

  • Change of Postural sway score

    Postural sway is a swing of the body while a person is standing in upright position.

    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.

Study Arms (2)

women without dysmenorrheal syndrome

women without dysmenorrheal syndrome

Other: dual task

women with dysmenorrheal syndrome

women with dysmenorrheal syndrome

Other: dual task

Interventions

mental and motor tasks will be performed while standing. Motor task: holding mini blocks Mental task: Counting the numbers from 200 to 1

women with dysmenorrheal syndromewomen without dysmenorrheal syndrome

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women with and without pain at menstrual cycles

You may qualify if:

  • Have dysmenorrheal syndrome
  • Have menstrual cycle without pain

You may not qualify if:

  • Have another health problem (systemic, neurologic, orthopedic or psychiatric)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof,PhD

Study Record Dates

First Submitted

July 6, 2018

First Posted

July 16, 2018

Study Start

July 30, 2018

Primary Completion

September 30, 2018

Study Completion

October 30, 2018

Last Updated

July 16, 2018

Record last verified: 2018-07