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

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)

  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:

  1. Having a history of pregnancy
  2. Having an acute genital infection
  3. 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

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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