Menstrual ProblemNCT04985045
Menstrual Health and Genital Hygiene Status in Cerebral Palsy
An observational study of Menstrual Problem and Cerebral Palsy, run by Özge Çoban.
Trial summary
There is little information about the menstrual health and genital hygiene behaviors of young women with CP. The most important reason for this is that women with CP did not meet the inclusion criteria and were excluded from the study. Read more about this study
- Who is it for?
- Ages 10 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Problem, Cerebral Palsy, Women's Health
- What is being tested?
- Evaluation
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 30 Sep 2021
- 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 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women with menstrual cycle
Who may be able to join
- for women with cerebral palsy (CP)
- Participating in the research voluntarily,
- Being diagnosed with CP
- To be GMFCS level I-II-II
- to be 10-30 years old,
- Being able to read and write Turkish,
Show all 16Show fewer
- Not having any mental problems that prevent cooperation and understanding,
- Being a woman
- To have menstruated at least once.
- For healthy women
- Participating in the research voluntarily,
- to be 10-30 years old,
- Being able to read and write Turkish,
- Not having any mental problems that prevent cooperation and understanding,
- Being a woman
- To have menstruated at least once.
Who cannot join
- Having a history of pregnancy
- Having an acute genital infection
- To have undergone gynecological surgery.
About this study
Official title: Determination of Menstrual Health and Genital Hygiene Status in Women With Cerebral Palsy
There is little information about the menstrual health and genital hygiene behaviors of young women with CP. The most important reason for this is that women with CP did not meet the inclusion criteria and were excluded from the study. This may lead to a knowledge gap that limits the design of approaches that can help women and families with CP. Therefore, this study was planned to determine menstrual health and genital hygiene behaviors in women with CP.
- Conditions
- Menstrual Problem, Cerebral Palsy, Women's Health
- Being tested
- Evaluation
- Medical subject headings
- Menstruation Disturbances, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
Individuals' menstrual status, pain, menstrual symptoms and genital hygiene behaviors will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Healthy women will be included Receives: Other: Evaluation | |
| Cerebral palsy group | Women with cerebral palsy will be included Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menstrual Pain
The highest pain intensity experienced by individuals during the menstrual period will be determined using the visual analog scale. Individuals will be asked to determine the highest pain intensity experienced during menstruation on a straight line from 0 to 10 cm. In this chart, "0" means I have no pain, "10" means I have unbearable pain. Facial expressions will be added below the line to increase the clarity of the assessment. At the same time, adolescents will be asked to mark where the pain is on the front and back body images.
Measured: A month
Menstruation-related symptoms
Menstruation-related symptoms of individuals will be determined using the "Menstruation Symptom Scale (MSS)". The Menstruation Symptom Scale was developed by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. It is a widely used scale in studies conducted in many different countries. The scale consists of 22 items questioning the symptoms related to menstruation and is scored in a five-point Likert type as never (1), rarely (2), sometimes (3) often (4) and always (5). The total score of MSS is calculated by taking the mean score of all items in the scale. An increase in the total score indicates an increase in the severity of menstrual symptoms. The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints', 'Menstrual Pain' and 'Coping Methods'.
Measured: A month
Genital Hygiene status
The genital hygiene behaviors of individuals will be evaluated using the "Genital Hygiene Behaviors Scale (GHDS)". The GHQ scale is a five-point Likert-type scale consisting of 23 items and 3 sub-dimensions developed by Karahan (2017). The level of agreement with the statements is scored as "Totally agree (5)", Agree (4), Undecided (3) Disagree (2), Completely disagree (1). The total score is obtained by adding the point values of the answers given to all the statements. The first 12 items of the scale include general hygiene habits, 13-20. substances, menstrual hygiene, 21-23. items are intended to determine abnormal finding awareness. 5 items of the scale have reverse entries. The total score varies between 23-115. Higher scores indicate improved genital hygiene.
Measured: A month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start1 Aug 2021 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual ProblemStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Özge Çoban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Özge Çoban, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985045
- Sponsor's protocol ID
- 2021/191
- Status last verified
- Jul 2021
- First submitted
- 26 Jul 2021
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turker D, Dogan H, Coban O, Goksuluk MB, Ozengin N, Un Yildirim N. Menstrual health and genital hygiene status in adolescent girls and young women with cerebral palsy. Women Health. 2023 Apr;63(4):243-250. doi: 10.1080/03630242.2023.2171175. Epub 2023 Feb 12.
PubMed 36775296
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Menstrual Health and Genital Hygiene Status in Women With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04985045
- Acronym / sponsor ID
- 2021/191
- Conditions
- Menstrual Problem, Cerebral Palsy, Women's Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Özge ÇobanUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 2 Aug 2021 (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.
There is little information about the menstrual health and genital hygiene behaviors of young women with CP. The most important reason for this is that women with CP did not meet the inclusion criteria and were excluded from the study. This may lead to a knowledge gap that limits the design of approaches that can help women and families with CP. Therefore, this study was planned to determine menstrual health and genital hygiene behaviors in women with CP.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: EvaluationHealthy women will be included |
| Cerebral palsy group | – | Other: EvaluationWomen with cerebral palsy will be included |
Who may qualify
- Ages
- 10 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women with menstrual cycle
Key inclusion criteria (16 listed)
- for women with cerebral palsy (CP)
- Participating in the research voluntarily,
- Being diagnosed with CP
- To be GMFCS level I-II-II
- to be 10-30 years old,
Key exclusion criteria (3 listed)
- Having a history of pregnancy
- Having an acute genital infection
- To have undergone gynecological surgery.
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 |
|---|---|---|
| EvaluationIndividuals' menstrual status, pain, menstrual symptoms and genital hygiene behaviors will be evaluated. | Other | Cerebral palsy group, Control group |
Primary outcome
Menstrual Pain
Time frame: A month
The highest pain intensity experienced by individuals during the menstrual period will be determined using the visual analog scale. Individuals will be asked to determine the highest pain intensity experienced during menstruation on a straight line from 0 to 10 cm. In this chart, "0" means I have no pain, "10" means I have unbearable pain. Facial expressions will be added below the line to increase the clarity of the assessment. At the same time, adolescents will be asked to mark where the pain is on the front and back body images.
Menstruation-related symptoms
Time frame: A month
Menstruation-related symptoms of individuals will be determined using the "Menstruation Symptom Scale (MSS)". The Menstruation Symptom Scale was developed by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. It is a widely used scale in studies conducted in many different countries. The scale consists of 22 items questioning the symptoms related to menstruation and is scored in a five-point Likert type as never (1), rarely (2), sometimes (3) often (4) and always (5). The total score of MSS is calculated by taking the mean score of all items in the scale. An increase in the total score indicates an increase in the severity of menstrual symptoms. The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints', 'Menstrual Pain' and 'Coping Methods'.
Genital Hygiene status
Time frame: A month
The genital hygiene behaviors of individuals will be evaluated using the "Genital Hygiene Behaviors Scale (GHDS)". The GHQ scale is a five-point Likert-type scale consisting of 23 items and 3 sub-dimensions developed by Karahan (2017). The level of agreement with the statements is scored as "Totally agree (5)", Agree (4), Undecided (3) Disagree (2), Completely disagree (1). The total score is obtained by adding the point values of the answers given to all the statements. The first 12 items of the scale include general hygiene habits, 13-20. substances, menstrual hygiene, 21-23. items are intended to determine abnormal finding awareness. 5 items of the scale have reverse entries. The total score varies between 23-115. Higher scores indicate improved genital hygiene.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Derived from this study: PubMed 36775296Turker D, Dogan H, Coban O, Goksuluk MB, Ozengin N, Un Yildirim N. Menstrual health and genital hygiene status in adolescent girls and young women with cerebral palsy. Women Health. 2023 Apr;63(4):243-250. doi: 10.1080/03630242.2023.2171175. Epub 2023 Feb 12.
- Individual participant dataSharing planned: No
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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 Menstrual Problem and Cerebral Palsy, run by Özge Çoban.
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 16 inclusion and 3 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 2 Aug 2021. 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?
Menstrual Pain (time frame: A month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04985045, which also lists 1 linked publication.
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 2 Aug 2021.