NCT06634953

Brief Summary

The goal of this observational study is to examine menstrual characteristics and symptoms in adolescent volleyball athletes compared to non-athlete adolescents. The main question it aims to answer is: How do menstrual symptoms and characteristics differ between adolescent volleyball athletes and non-athletes? The study included 154 adolescents aged 10-19, divided into 77 volleyball athletes (average age 15.09) and 77 non-athletes (average age 14.79). Assessments covered menstruation age, regularity, dysmenorrhea characteristics, and menstrual symptoms using the Menstrual Symptom Questionnaire (MSQ).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 3, 2024

Last Update Submit

October 8, 2024

Conditions

Keywords

volleyballadolescent athletemenstruation

Outcome Measures

Primary Outcomes (2)

  • Menstrual Pain

    Menstruation related pain ( pain in the first 3 days of menstruation) intensity will be measured as a primary outcome using the the Visual Analog Scale (VAS). This outcome will measure the level of pain experienced by participants and the results will be reported as a continuous variable. The VAS consists of a 10 cm horizontal line with endpoints labeled "no pain" (0) and "worst pain imaginable" . Participants will mark the point on the line that best represents their pain intensity. The scores range from 0 (no pain) to 10 (worst pain), with higher scores indicating worse pain.

    3 months ( will cover 3 menstrual cyles)

  • Menstrual symptoms (assessed using the Menstruation Symptom Questionnaire)

    Menstrual symptoms will be assessed using the Menstruation Symptom Questionnaire (MSQ) designed to measure the severity and frequency of physical and emotional symptoms associated with menstruation (Negative Effects/Somatic Complaints, Menstrual Pain, and Coping Methods). The MSQ consists of 24 items, each rated on a 5-point Likert scale where 0 indicates no symptoms and 5 indicates the most severe symptoms. The total MSQ score ranges from 0 to 120, with higher scores reflecting worse menstrual symptoms.

    3 months. The outcome will be evaluated before starting the study and after 12 weeks. It will be reported as a continuous variable to quantify changes in symptom severity over time.

Study Arms (2)

Adolescent female volleyball athletes

willingness to participate in the research, female gender, experience of menstruation cycles for at least 1 year, age between 10 and 19 years, volleyball sport license for at least 3 years, and practice of volleyball at least 4 days a week for at least 3 years

Healthy adolescent females

willingness to participate in the research, female gender, experience of menstruation cycles for at least 1 year, age between 10 and 19 years,

Eligibility Criteria

Age10 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

10-19 years old females

You may qualify if:

  • willingness to participate in the research,
  • female gender,
  • experience of menstruation cycles for at least 1 year,
  • age between 10 and 19 years,
  • having a volleyball sport license for at least 3 years,
  • practicing of volleyball at least 4 days a week for at least 3 years.

You may not qualify if:

  • being pregnant
  • experiencing acute genital infection
  • gynecological or urological surgery
  • having a diagnosis with an endocrine, systemic, or psychological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri Universitesi

Ankara, 06010, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT PhD

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 10, 2024

Study Start

January 3, 2024

Primary Completion

March 15, 2024

Study Completion

March 15, 2024

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Participants datas will not be shared till publicaiton is confirmed

Locations