跳至主要内容
临床试验/NCT05856656
NCT05856656已完成不适用

Music Therapy as a Tool for Anxiety Reduction in Localized Breast Cancer

Institut Cancerologie de l'Ouest2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年10月10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
27
试验地点
2
主要终点
To evaluate the impact of music therapy on anxiety in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy.

研究概览

简要总结

Breast cancer is the number one cancer in women worldwide, with 58,500 new cases in metropolitan France in 2018. The announcement of the cancer, the treatment methods and their side effects can generate unpleasant emotions, such as fear, for example, and the resources for coping with them differ according to the patient. Coming to the hospital as an outpatient for chemotherapy is in itself a source of anxiety.

The use of music in the treatment process is a therapy that can help patients to reduce the intensity of their unpleasant emotions. Active music therapy involves the patient playing an instrument, including voice and body movement in rhythm, without requiring any musical skills. The presence of a qualified music therapy professional is essential, particularly in the reception of the emotions that may be generated during the sessions. These sessions can be collective or individual. In breast cancer, music therapy has been shown to be effective in reducing pain, anxiety, depressive symptoms and length of hospitalisation in patients undergoing mastectomy.

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
None

入排标准

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

入选标准

  • Patient with localized breast cancer
  • Indication for adjuvant or neoadjuvant chemotherapy
  • Patient > 18 years of age
  • Patient with signed consent
  • Patient affiliated to a social security scheme

排除标准

  • Metastatic patient
  • Triple negative patient
  • Patient not eligible for curative surgery
  • Patient who has already received chemotherapy
  • Unaided deaf patient
  • Women who are pregnant, likely to be pregnant or breastfeeding
  • A patient presenting a depressive episode or a psychotic pathology at the time of the initial consultation
  • Patient who does not understand French
  • Cognitive disorder or inability to understand,
  • Patient protected by law, under court protection, guardianship or curatorship

研究组 & 干预措施

Music therapy arm

Experimental

A music therapy will be offered to patients before the first 3 chemotherapy cycles

干预措施: Music therapy (Behavioral)

Standard care arm

No Intervention

Standard patient care, no intervention

结局指标

主要结局

To evaluate the impact of music therapy on anxiety in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy.

时间窗: 5 months

Changes in anxiety before the first and third chemotherapy sessions will be measured using the State Trait Anxiety Inventory (= STAI etat score).

次要结局

未报告次要终点

研究者

发起方
Institut Cancerologie de l'Ouest
申办方类型
Other
责任方
Sponsor

研究点 (2)

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