- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04985045
Menstrual Health and Genital Hygiene Status in Cerebral Palsy
July 26, 2021 updated by: Özge Çoban
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
128
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 30 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with menstrual cycle
Description
Inclusion Criteria:
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,
- 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.
Exclusion Criteria:
- Having a history of pregnancy
- Having an acute genital infection
- To have undergone gynecological surgery.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control group
Healthy women will be included
|
Individuals' menstrual status, pain, menstrual symptoms and genital hygiene behaviors will be evaluated.
|
|
Cerebral palsy group
Women with cerebral palsy will be included
|
Individuals' menstrual status, pain, menstrual symptoms and genital hygiene behaviors will be evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
A month
|
|
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'.
|
A month
|
|
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.
|
A month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
August 1, 2021
Primary Completion (ANTICIPATED)
August 30, 2021
Study Completion (ANTICIPATED)
September 30, 2021
Study Registration Dates
First Submitted
July 26, 2021
First Submitted That Met QC Criteria
July 26, 2021
First Posted (ACTUAL)
August 2, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 2, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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