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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04985045
Other study ID # 2021/191
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date September 30, 2021

Study information

Verified date July 2021
Source Gulhane School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 128
Est. completion date September 30, 2021
Est. primary completion date August 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 10 Years to 30 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Özge Çoban

Outcome

Type Measure Description Time frame Safety issue
Primary 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. A month
Primary 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'. A month
Primary 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. A month
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