- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05013619
Pain Prevalence, Distribution, Effect on Activities of Daily Life in Patients With Adolescent Cerebral Palsy
Pain Prevalence, Distribution, Effect on Activities of Daily Life in Patients With Adolescent Cerebral Palsy and a Comparion of the Mother-child Report
Pain is the most common secondary condition in patients with CP and the most important factor associated with reduced health-related quality of life. Pain in adolescents with CP is reported approximately 50-75%. Despite being a condition that can be seen with such a high prevalence, it is difficult for researchers and clinicians to capture this subjective perception in CP, as the individual may be a small child, may be cognitively impaired, visually impaired, or have communication difficulties. For these reasons, unrecognized pain can have negative effects on quality of life and participation in daily living activities, both as a result of limited mobility resulting from pain itself and fear-driven avoidance of specific activities. Self-report of pain is appropriate for individuals with CP without cognitive impairment. However, depending on the severity of communication impairment, self-report may be limited or even impossible to obtain in individuals with severe CP. In the case of individuals with CP, self-report supplemented with parent report, when possible, is the recommended strategy.
The aims of this study: (i) to explore what is known about the prevalence, location, intensity and the effect of pain on daily lives of adolescents with CP; (ii) to demonstrate the relation between pain, clinical and sociodemographic characteristics; (iii) to compare self-reports of pain with mothers'reports of their child's pain.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for patients:
- adolescents, aged 8 to 18 years with a diagnosis of cerebral palsy
- able to understand and answer the questions
Exclusion Criteria for patients:
- previous interventional procedures, such as surgery within the last one month
- using painkillers
- having concomittan diagnosed 'Autism Spectrum Disorder' or 'Attention Deficit Hyperactivity Disorder' or another neuromuscular disorder
Inclusion Criteria for their mothers:
- primary caregivers who spend most of their time with their children
- do not work outside the home
Exclusion Criteria for their mothers:
- not primary caregivers who spend most of their time with their children
- work outside the home
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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adolescent cerebral palsy
Demographical data, the subtypes of CP, Gross Motor Functional Classification System level, circumstances of pain, pain questionnaire will be analyzed.
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It will be questioned in which situations the pain occurred in the previous week (at rest from spasms, at rest from splints, on feeding, on moving, on dressing, at night, on exercise, on other treatments, on botulinum toxin application) and record as yes/no.
Participants will be asked to respond to the initial question "Over the past month, have you experienced physical pain?" (yes or no).
Those responding "yes" will be asked "Please indicate how severe your pain was over the past month, on average," with response options from 1 (very little pain) to 10 (extremely painful).
They will be also asked to indicate "How much the pain gets in the way of your daily activities over the past month" from a low of 1 (does not get in the way at all) to 10 (unable to carry out activities because of the pain).
Finally, they will be asked to indicate the body regions in which they experienced pain.
Severity of CP will be determined based on the Gross Motor Functional Classification System (GMFCS).
GMFCS is a standardised measure that classifies gross motor functions in children with CP.
Children in level I are very independent in motor functions while those in level V are the least independent
The subtypes of CP will be classified, using the Swedish classification, into spastic (tetraplegia, diplegia and hemiplegia), ataxic, dyskinetic and mixed
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adolescent cerebral palsy's mother
pain questionnaire will be analyzed.
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Participants will be asked to respond to the initial question "Over the past month, have you experienced physical pain?" (yes or no).
Those responding "yes" will be asked "Please indicate how severe your pain was over the past month, on average," with response options from 1 (very little pain) to 10 (extremely painful).
They will be also asked to indicate "How much the pain gets in the way of your daily activities over the past month" from a low of 1 (does not get in the way at all) to 10 (unable to carry out activities because of the pain).
Finally, they will be asked to indicate the body regions in which they experienced pain.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Gross Motor Functional Classification System level
Time Frame: Through study completion, an average of 1 month
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GMFCS is a standardised measure that classifies gross motor functions in children with CP.
Children in level I are very independent in motor functions while those in level V are the least independent .
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Through study completion, an average of 1 month
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Pain distribution
Time Frame: Through study completion, an average of 1 month
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It will be questioned in which situations the pain occurred in the previous week (at rest from spasms, at rest from splints, on feeding, on moving, on dressing, at night, on exercise, on other treatments, on botulinum toxin application)
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Through study completion, an average of 1 month
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The pain questionnaire
Time Frame: Through study completion, an average of 1 month
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Participants will be asked to respond to the initial question "Over the past month, have you experienced physical pain?" (yes or no).
Those responding "yes" will be asked "Please indicate how severe your pain was over the past month, on average," with response options from 1 (very little pain) to 10 (extremely painful).
They will be also asked to indicate "How much the pain gets in the way of your daily activities over the past month" from a low of 1 (does not get in the way at all) to 10 (unable to carry out activities because of the pain).
Finally, they will be asked to indicate the body regions in which they experienced pain.
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Through study completion, an average of 1 month
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Collaborators and Investigators
Investigators
- Principal Investigator: Fatma Özcan, MD, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20 (Sophies Minde Ortopedi AS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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