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临床试验/NCT05344820
NCT05344820Unknown不适用

The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年5月19日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
level of quality of life

研究概览

简要总结

The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

详细描述

A randomized controlled study on the effect of mandala application on cancer related fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy has not been found in the literature.

The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • 18 years or older
  • Conscious and no communication problems
  • Being literate
  • Having a cancer diagnosis
  • Receiving chemotherapy treatment (planned to continue treatment for 8 more weeks)
  • Willing to participate in our study voluntarily

排除标准

  • Not being willing to participate in the research
  • Desire to leave the study at any time
  • Deterioration of compliance with the working criteria during the time of the study,
  • Those who do not participate in up to four mandala applications during the study period
  • Those who cannot use a pen
  • Those with a diagnosis of psychiatric and neurological disease
  • Patients who are scheduled for drug intervention, radiotherapy, surgery other than chemotherapy within 8 weeks

结局指标

主要结局

level of quality of life

时间窗: 1 week

Level of quality of life as assessed by the Quality of Life Scale for the Treatment and Research of Cancer (min:0, max:100,with higher values indicating a higher functioning in functional scales and an increased presence of symptoms in symptom scales)

level of fatigue

时间窗: 1 week

level of fatigue assessed by the Piper Fatigue Scale (min:0, max, 100, higher values means higher fatigue)

次要结局

  • level of alexithymia(1 week)
  • level of rumination(1 week)

研究者

发起方
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elif Yıldırım Ayaz

Principal Investigator

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

研究点 (2)

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