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临床试验/NCT07752667
NCT07752667已完成不适用

The Effect of a Music-Assisted Mandala Intervention on Psychological Well-being and Quality of Life in Cancer Patients Undergoing Chemotherapy

Istanbul Medeniyet University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月30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
40
试验地点
1
主要终点
Change in the Psychological Impact of Cancer Score, as Measured by the Psychological Impact of Cancer Scale, Compared with the Baseline Value.

研究概览

简要总结

Cancer is one of the most significant global health issues of our time. Chemotherapy, one of the methods used to treat cancer, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. It has been reported that treatment adherence problems are more common in patients with a high symptom burden associated with these side effects. For this reason, it is crucial that patients have achieved psychological adaptation to their condition and treatment in order for the treatment to be effective, to ensure that toxicity is kept under control, and to ensure that the course of the disease progresses favourably. In cases of illness and failure to adhere to treatment, this can lead to unnecessary visits to the doctor, visits to A&E, hospitalisation, and an increase in the use of healthcare services and associated costs; it may also result in the development of treatment resistance, an increased burden on patients and carers, disease progression, and even death. Various non-pharmacological approaches, such as exercise, expressing emotions and art therapy, can be used to ensure the patient's adherence to treatment. It has been reported that mandala practice, a form of art therapy, reduces anxiety, fatigue, insomnia and stress. In light of this information, the aim of this study is to assess the effect of mandala practice on psychological adjustment to the disease and treatment, and on quality of life, in cancer patients undergoing chemotherapy.

详细描述

Today, cancer is a leading cause of death worldwide. However, thanks to advances in medicine and modern technology, the availability of tests and diagnostic methods used to detect cancer at an early stage, and the use of increasingly effective treatments-including chemotherapeutic agents-the number of cancer survivors is also rising. Chemotherapy, one of these treatment methods, not only treats the disease but also causes numerous physiological and psychological side effects that adversely affect quality of life. It has been reported that treatment adherence problems are more common in patients with a high symptom burden associated with these side effects. For this reason, it is crucial that patients have achieved psychological adaptation to their condition and treatment in order for the treatment to be effective, to ensure that toxicity is managed, and to ensure a positive progression of the disease. In cases of non-adherence to treatment or non-compliance with the condition, this can lead to unnecessary visits to the doctor, visits to A&E, hospitalisation, and an increase in the use of healthcare services and associated costs; it may also result in the development of treatment resistance, an increased burden on patients and carers, disease progression, and even death. Various non-pharmacological approaches, such as exercise, expressing emotions and art therapy, can be used to ensure the patient's adherence to treatment.Mandala, one of the forms of art therapy, is a Sanskrit term meaning 'circle' or 'centre'. It describes designs created by the repetition of geometric patterns in various forms, centred around a point and arranged in a pattern. Its origins date back to India, and it is a form of art practised in Asian culture as a means of religious contemplation and meditation. The mandala, one of the tools used by art therapists, is employed to promote relaxation and generate positive energy. It is believed that the drawings people make inside the circle represent their thoughts at that moment, help them to forget the turmoil they are experiencing, and assist them in withdrawing into themselves by enabling them to concentrate on the act of drawing itself. A review of the literature indicates that mandala practice has been reported to reduce anxiety, fatigue, insomnia and stress. In light of this information, the aim of this study is to assess the effect of mandala practice on psychological adjustment to the disease and treatment, and on quality of life, in cancer patients undergoing chemotherapy.

研究设计

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

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

  • patients who have been diagnosed with cancer,
  • aged 18 or over,
  • receiving chemotherapy for the first time,
  • able to hold a pen,
  • agreed to take part in the study

排除标准

  • Decline to participate in the study or do not provide written informed consent.
  • Have physical conditions that would prevent participation in the mandala intervention (e.g., severe pain, severe nausea, or severe vomiting).
  • Have mental health conditions or cognitive impairment that limit their ability to communicate or participate in the intervention.
  • Experience fatigue primarily due to causes other than chemotherapy (e.g., severe anemia with hemoglobin < 9 g/dL).
  • Are unable to hold or use a pen to complete the mandala activity.

研究组 & 干预措施

Control

No Intervention

The control group will complete the Patient Information Form, the EORTC QLQ-C30 and the Psychological Impact of Cancer Scale; no specific intervention will be carried out, and the clinic's standard protocol will be followed.

Mandala Group

Experimental

After watching an instructional video on how to carry out the mandala activity, the patient will complete their first mandala colouring session during the treatment. The patient and their family will then be sent home with a mandala colouring book and coloured pencils to carry out the mandala activity on a weekly basis. The experimental group will repeat the mandala activity once a week for 8 weeks as part of their chemotherapy treatment, with each session lasting 60-90 minutes (a different mandala will be provided each week). They will be able to choose any design and colour they wish from the mandala book. Patients will be advised to listen to classical music during the activity. Patients will be contacted by telephone on a weekly basis to check whether they have carried out the mandala session.

干预措施: Mandala (Behavioral)

结局指标

主要结局

Change in the Psychological Impact of Cancer Score, as Measured by the Psychological Impact of Cancer Scale, Compared with the Baseline Value.

时间窗: Baseline, Week 4, and Week 8.

The psychological impact of cancer will be assessed using the Psychological Impact of Cancer Scale. Higher scores indicate a better psychological impact.

Change in patients' quality of life scores, as measured by the EORTC QLQ-C30, compared with baseline

时间窗: Baseline, Week 4, and Week 8

Patients' quality of life will be assessed using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire) scale. Higher scores indicate a higher quality of life.

次要结局

未报告次要终点

研究者

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

Emel Emine Kayikci

Assisstant Professor

Istanbul Medeniyet University

研究点 (1)

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