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临床试验/NCT03664947
NCT03664947已完成不适用

The Impact of Video Based Game Exercise Approaches on Sleep in Children With Acute Lymphoblastic Leukemia: Randomized Single Blind Controlled Study

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Polysomnography, Characteristics of Sleep

研究概览

简要总结

Sleep is one of the basic and indispensable daily life activities that affect the quality of life and health of individuals and is a concept with physiological, psychological and social dimensions. In the literature, sleep difficulties and problems have begun to be investigated in children with acute lymphoblastic leukemia and have not been found in national publications. In these children, sleep quality, strengths and disorders and a study evaluating this variation on a scale have not been found. For this reason, our study will be done in order to determine the factors affecting sleep and sleep in children with cancer and to show the effect of exercise on these factors.

详细描述

Primeraly that progresses in the disease process, secondary problems seen with the effects of symptoms make it difficult to cope with disease and treatment process in children with acute lymphoblastic leukemia (ALL) . Sleep difficulty is not affected by the direct effects of the disease but it is affected and becomes more difficult with the fatigue and difficulty of treatment as a secondary. Parents with ALL children stated that they experienced 12.4% of sleeping difficulty. It turns out that about a quarter of the children are sleeping problems. It is stated that 27% of these children have drowsiness, and more than 25% of them have frequent awakenings at night. It is also stated that parents use the option of rest-sleep as an option to benefit from treatment in coping with the disease, but children with sleeping difficulties also make it difficult to treat them. Being a healthcare professional as a biopsychosocial approach model and planning the treatment interventions for the deficiencies and disorders that will be done in order to get rid of the symptoms of the disease as soon as possible will make it easier to cope with the disease with both child and parent and multidisciplinary approach. In this way, we will investigate the effects of children's exercise habits on their sleep and sleep related complaints by using video-based game consoles which are currently used in our workout approaches. The games to be selected from the aerobic exercise programs that are used to increase the functional capacity on the basis of exercise will also be targeted to the exercises with maximum motivation and participation of the children. In the exercises where goodness and continuity are also taken into consideration, in-game guidance will be provided with verbal commands under the supervision of a physiotherapist.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Having ALL a diagnosis
  • Being between 2-18 years of age
  • Therapy (surgery, chemotherapy, radiotherapy) to be finished

排除标准

  • Continue active treatment (surgery, chemotherapy, radiotherapy)
  • Recurrence of the disease
  • Any mental / physical problem that will have a cooperative problem

结局指标

主要结局

Polysomnography, Characteristics of Sleep

时间窗: 12 weeks

Polysomnography is used increasingly to investigate patients with possible sleep apnoea/ hypopnoea syndrome. It is a report that which indicate sleep quality.

次要结局

  • Epworth Sleepiness Scale (ESS)(12 weeks)
  • Pitsburg Sleep Quality Index (PSQI)(12 weeks)
  • Childhood Sleep Habit Questionnaire (CSHQ)(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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