Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05013619 |
Other study ID # |
20 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
July 1, 2021 |
Est. completion date |
October 1, 2021 |
Study information
Verified date |
August 2021 |
Source |
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
Description:
The investigators will record demographical data including age, gender, height (cm), weight
(kg), body mass index (BMI), school type, type of family (core or combined family) of the
children and socioeconomic status of the family, mothers' age and educational level. The
subtypes of CP will be classified, using the Swedish classification, into spastic
(tetraplegia, diplegia and hemiplegia), ataxic, dyskinetic and mixed. Severity of CP will be
determined based on the Gross Motor Functional Classification System. 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. The pain questionnaire described by Doralp
et al (14) will be used both for the self-evaluation of adolescents with CP' pain and for
mothers to evaluate their children's pain. 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 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.