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临床试验/NCT07269340
NCT07269340已完成不适用

The Effect of Mandala Painting During Chemotherapy on Anxiety, Nausea, and Comfort Levels

Uludag University2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2025年9月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
2
主要终点
Change from baseline Anxiety level

研究概览

简要总结

In addition to managing drug side effects that arise during cancer treatment, maintaining the patient's psychosocial well-being is also very important. Therefore, the aim of this project is to examine the effect of mandala painting during chemotherapy on anxiety, nausea, and comfort levels. This project aims to reduce the negative effects of chemotherapy, such as nausea, anxiety, and decreased comfort, by distracting the patient's attention through the non-invasive and non-pharmacological practice of mandala coloring in patients undergoing chemotherapy.

Mandala painting is a distraction and positive focus practice. A limited number of studies conducted on cancer patients have shown that it reduces distress and improves psychological well-being. However, no study in the literature has comprehensively addressed the symptoms experienced by patients during chemotherapy, such as anxiety, nausea, intense stress, and impaired comfort. The research will be conducted on patients undergoing chemotherapy for the first time, and patients in the experimental group will engage in mandala coloring for at least 30 minutes. Data obtained from assessments conducted before and after chemotherapy will be compared with control group data. This project will provide a more comprehensive assessment of the effect of mandala painting, a non-pharmacological intervention, on the negative symptoms of patients undergoing chemotherapy for the first time.

In addition to its scientific contribution, it is believed that effective symptom management can contribute to patients' well-being. Furthermore, if nausea can be controlled, the need for antiemetics during treatment can be reduced. This will also contribute to reducing unwanted drug effects and lowering costs.

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
Single (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 old,
  • Receiving chemotherapy for the first time

排除标准

  • Have a lower education level than secondary school (The STAI is appropriate for those who have at least a sixth-grade reading level),
  • Diagnosed with psychiatric and neurological diseases,
  • Diagnosed with dementia,
  • Received chemotherapy treatment more than once,
  • Planned to receive radiotherapy treatment together with chemotherapy.

研究组 & 干预措施

Mandala Painting

Experimental

Patients receiving chemotherapy for the first time will have mandala painting done during their chemotherapy treatment.

干预措施: mandala painting (Other)

Control Group

No Intervention

The patients in this group will not receive any intervention and will receive standard treatment and care during chemotherapy.

结局指标

主要结局

Change from baseline Anxiety level

时间窗: baseline, 60-120 minute

Baseline and post-intervention anxiety level assessed by trained research nurse using Spielberg's State-Trait Anxiety Inventory (STAI). The test scores between 20 and 80, with higher scores indicating more generalized and stronger anxiety.

次要结局

  • Nausea level(baseline, 60-120 minute)
  • Satisfaction level(60-120 minute)
  • Comfort level(baseline, 60-120 minute)

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seda Pehlivan

Associate professor

Uludag University

研究点 (2)

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