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临床试验/NCT06735456
NCT06735456已完成不适用

The Effect of Mandala on Anxiety, Physiological Parameters and Patient Satisfaction in Women With Breast Cancer Receiving Chemotherapy

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年2月24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
入组人数
54
试验地点
1
主要终点
Physiological parameter 1

研究概览

简要总结

This study will be conducted to examine the effect of mandala painting on anxiety, physiological parameters and patient satisfaction in women with breast cancer receiving chemotherapy.

详细描述

Breast cancer is among the most common cancers that cause death in women in the world and in our country (1). One of the most commonly used treatment options for breast cancer is chemotherapy. However, many side effects occur depending on the chemotherapy regimen used. The most common side effects in patients receiving chemotherapy are; nausea, vomiting, anemia, fatigue, insomnia, mucositis, and peripheral neuropathy (2, 3). It is stated that the probability of anxiety in people with cancer is 50% or more, while the rate of chronic anxiety is 30%. It is expected that the quality of life will be positively affected by detecting and reducing the level of anxiety and adapting patients to their own treatment (4). Mandala, a type of art therapy method; Although it has various shapes, the round one is generally preferred and is a meditation tool used to convey feelings and thoughts. Studies have shown that art therapy helps individuals feel more peaceful by helping to alleviate strong negative emotions that cause severe discomfort (7). In a study conducted in Hong Kong, the sample group included women with both breast cancer and gynecological cancer. Art therapy was applied to the participants, and as a result of the research, it was observed that the women's psychological distress decreased and their mental well-being increased (8). It is known that the problems experienced by cancer patients can be reduced by changing cognitive focus, similar to art therapy. In a study, cancer patients receiving chemotherapy watched TV series and movies (51.3%), dreamed (26.6%), listened to music (26.6%), visited friends and relatives (19.6%), looked at flowers (14%), walked or walked. It is observed that their depression and anxiety decrease when they engage in activities such as exercising (14%) (9).In the literature, there are mandala studies applied to different patient groups, but no national or international study has been found regarding the effects of mandala painting during chemotherapy in breast cancer patients. Therefore, this study will be conducted to examine the effect of mandala painting on anxiety, physiological parameters and patient satisfaction in women with breast cancer 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 (Participant, Outcomes Assessor)

盲法说明

Since the application will be performed by the researcher, patients will be blinded in this study. The statistician will be blinded in the evaluation of the data.

入排标准

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

入选标准

  • •Being diagnosed with breast cancer,
  • •Being receiving adjuvant or neoadjuvant chemotherapy,
  • •Being over 18 years of age,
  • •Ability to communicate in Turkish,
  • •Not having a physical disability related to the upper extremities,
  • •Agreeing to participate in the study.

排除标准

  • •Advanced stage cancer patients,
  • •Having visual, hearing and speech disabilities,
  • •Individuals with mental and neuropsychiatric diseases will not be included in the sample.

研究组 & 干预措施

Mandala Group

Experimental

The patient will undergo mandala painting during 1 session of chemotherapy.

干预措施: Mandala (Other)

Control Group

No Intervention

No application will be made to this group by the researcher.

结局指标

主要结局

Physiological parameter 1

时间窗: 2 hours (pre-test and post-test)

Temperature

Physiological parameter 2

时间窗: 2 hours (pre-test and post-test)

Pulse

Physiological parameter 3

时间窗: 2 hours (pre-test and post-test)

Blood pressure

Physiological parameter 4

时间窗: 2 hours (pre-test and post-test)

spO2

Physiological parameter 5

时间窗: 2 hours (pre-test and post-test)

Respiratory rate

次要结局

  • Beck Anxiety Scale(2 hours (pre-test and post-test))

研究者

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

Filiz Ünal Toprak

Assoc. Prof. Dr.

Saglik Bilimleri Universitesi

研究点 (1)

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