AdolescentNCT06634953
The Impact of Volleyball on Menstrual Symptoms
An observational study of Adolescent and Female, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent, Female, Menstruation
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2024to 15 Mar 2024
- 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 10 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: 10-19 years old females
Who may be able to join
- 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.
Who cannot join
- being pregnant
- experiencing acute genital infection
- gynecological or urological surgery
- having a diagnosis with an endocrine, systemic, or psychological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Volleyball on Menstrual Symptoms in Adolescent Athletes
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).
Read the detailed description
The goal of this observational study is to investigate 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 their non-athlete peers?
The study included 154 adolescents aged 10-19 who had experienced menarche for at least one year. Participants were divided into two groups: 77 volleyball athletes (average age 15.09±1.33) and 77 non-athletes (average age 14.79±1.27). Assessments included menstruation age, regularity, use of menstruation delay pills, cycle characteristics (length, duration), and dysmenorrhea characteristics (onset, frequency, medication use, school/training absenteeism). The Menstrual Symptom Questionnaire (MSQ) evaluated menstrual pain, coping methods, and somatic complaints.
- Conditions
- Adolescent, Female, Menstruation
- Keywords
- volleyball, adolescent athlete, menstruation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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, |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start3 Jan 2024
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdolescentStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Seda Uluşahin, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634953
- Sponsor's protocol ID
- 2023-1569
- Status last verified
- Oct 2024
- First submitted
- 3 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants datas will not be shared till publicaiton is confirmed
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Volleyball on Menstrual Symptoms in Adolescent Athletes
- ClinicalTrials.gov ID
- NCT06634953
- Acronym / sponsor ID
- 2023-1569
- Conditions
- Adolescent, Female, Menstruation
- Keywords
- volleyball, adolescent athlete, menstruation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 10 Oct 2024 (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 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).
Detailed description
The goal of this observational study is to investigate 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 their non-athlete peers?
The study included 154 adolescents aged 10-19 who had experienced menarche for at least one year. Participants were divided into two groups: 77 volleyball athletes (average age 15.09±1.33) and 77 non-athletes (average age 14.79±1.27). Assessments included menstruation age, regularity, use of menstruation delay pills, cycle characteristics (length, duration), and dysmenorrhea characteristics (onset, frequency, medication use, school/training absenteeism). The Menstrual Symptom Questionnaire (MSQ) evaluated menstrual pain, coping methods, and somatic complaints.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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, |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 10-19 years old females
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- being pregnant
- experiencing acute genital infection
- gynecological or urological surgery
- having a diagnosis with an endocrine, systemic, or psychological disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Menstrual Pain
Time frame: 3 months ( will cover 3 menstrual cyles)
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.
Menstrual symptoms (assessed using the Menstruation Symptom Questionnaire)
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Individual participant dataSharing planned: No. Participants datas will not be shared till publicaiton is confirmed
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adolescent and Female, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Menstrual Pain (time frame: 3 months ( will cover 3 menstrual cyles)). 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 10 Oct 2024.