CClinicalTrials.gg
Status unknownNCT04985045Updated Aug 2, 2021

Menstrual Health and Genital Hygiene Status in Cerebral Palsy

An observational study in Menstrual Problem, Cerebral Palsy and Women's Health, sponsored by Özge Çoban. Status unknown. Open to female participants aged 10 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-02.

Sponsored by Özge Çoban · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
128
Ages
10 Years to 30 Years
Sex
Female
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Study 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. 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.

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Conditions studied

  • Menstrual Problem
  • Cerebral Palsy
  • Women's Health
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In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's planned enrollment of 128 is above the median of 63 across 455 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

This is the only study on the registry with Özge Çoban as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women with menstrual cycle

Inclusion criteria

for women with cerebral palsy (CP)

  1. Participating in the research voluntarily,
  2. Being diagnosed with CP
  3. To be GMFCS level I-II-II
  4. to be 10-30 years old,
  5. Being able to read and write Turkish,
  6. Not having any mental problems that prevent cooperation and understanding,
  7. Being a woman
  8. To have menstruated at least once.

For healthy women

  1. Participating in the research voluntarily,
  2. to be 10-30 years old,
  3. Being able to read and write Turkish,
  4. Not having any mental problems that prevent cooperation and understanding,
  5. Being a woman
  6. To have menstruated at least once.

Exclusion criteria

Exclusion Criteria:

  1. Having a history of pregnancy
  2. Having an acute genital infection
  3. To have undergone gynecological surgery.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
128 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control group

    Healthy women will be included

    Other: Evaluation

  • Cerebral palsy group

    Women with cerebral palsy will be included

    Other: Evaluation

Interventions

  • OtherEvaluation

    Individuals' menstrual status, pain, menstrual symptoms and genital hygiene behaviors will be evaluated.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: A month

  2. 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'.

    Time frame: A month

  3. 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.

    Time frame: A month

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04985045
Lead sponsor
Özge Çoban
Responsible party
Özge Çoban (Universith of Health Science, Health Science Faculty, Lecturer, Gulhane School of Medicine) — Sponsor-investigator
First posted
Aug 2, 2021
Start date
Aug 1, 2021 (estimated)
Primary completion
Aug 30, 2021 (estimated)
Completion
Sep 30, 2021 (estimated)
Last update
Aug 2, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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