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临床试验/NCT05164354
NCT05164354已完成不适用

The Effect of Cancer Therapy and Music Concert Applied to Children on Sleep

Inonu University2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2020年4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
105
试验地点
2
主要终点
Actigraphy device

研究概览

简要总结

The actigraph device continuously records the occurrence of limb movements and then collects the number of movements in a given time interval. Compared to polysomnography Actigraphy is a reliable and valid method for monitoring sleep in infants.

详细描述

Cancer is a disease characterized by rapid proliferation and uncontrollable growth of abnormal cells . According to the tumor statistics data of the Turkish Pediatric Oncology Group (TPOG), the incidence of cancer in children aged 10-14 in Turkey is 22.80 per million (n= 2756), while this rate is 7.35 per million in children aged 15-19 years (n= 2756). 886). Despite the high incidence of cancer, it has started to be seen as a life-threatening chronic disease rather than a terminal disease with the treatment methods developed in the field of pediatric oncology However, early initiation of treatment, effective treatment use, and high treatment success have made increasing the quality of life and psychosocial approach even more important. However, both cancer diagnosis and treatment reduce the child's quality of life and cause many psychosocial and physical problems.

Sleep plays a role in many important functions such as growth and development, tissue regeneration, energy conservation, and strengthening of the immune system in childhood.

Inadequate sleep quality and sleep disorders are frequently observed in children diagnosed with cancer . Sleep problems are seen in approximately half of children with cancer. Difficulty falling asleep, waking up suddenly during sleep, difficulty waking up, and excessive daytime sleepiness are symptoms that indicate inadequate sleep quality in children with cancer .

Sleep problems begin with the diagnosis of children with cancer, and the amount and quality of sleep of the child is negatively affected due to reasons such as unfamiliar environment, deterioration of sleep habits, and staying away from their own bed at the first admission to the clinic. In addition, symptoms such as side effects related to the treatment initiated, disruption of sleep routine due to treatment, and pain due to illness cause sleep problems . These sleep problems make it difficult for children to comply with treatment and reduce their quality of life.

Alternative pharmacological and non-pharmacological methods can be used in the management of cancer-related sleep disorders . Aromatherapy and listening to music are among the recommended non-pharmacological methods .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Single (Care Provider)

入排标准

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

入选标准

  • Being oriented, open to communication and cooperation

排除标准

  • Not in the induction phase of cancer treatment

结局指标

主要结局

Actigraphy device

时间窗: three days

The actigraph device continuously records the occurrence of limb movements and then collects the number of movements in a given time interval. Compared to polysomnography Actigraphy is a reliable and valid method for monitoring sleep in infants.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Arıcıoglu Sulun

Dr. Research Asistant

Inonu University

研究点 (2)

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