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临床试验/NCT05013619
NCT05013619已完成不适用

Pain Prevalence, Distribution, Effect on Activities of Daily Life in Patients With Adolescent Cerebral Palsy and a Comparion of the Mother-child Report

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Gross Motor Functional Classification System level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Gross Motor Functional Classification System level

时间窗: Through study completion, an average of 1 month

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 .

Pain distribution

时间窗: Through study completion, an average of 1 month

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)

The pain questionnaire

时间窗: Through study completion, an average of 1 month

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.

次要结局

未报告次要终点

研究者

发起方
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasin Demir

Physical Medicine and Rehabilitation Specialist

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

研究点 (1)

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