Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2
Completed NCT02897024 - A Comparison: High Intense Periodic vs. Every Week Therapy in Children With Cerebral Palsy (ACHIEVE) N/A