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临床试验/NCT07464964
NCT07464964已完成不适用

Effects of Music Therapy on Anxiety and Distress Levels During Radionuclide Treatment in Prostate Cancer Patients

Dokuz Eylul University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月1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
60
试验地点
1
主要终点
Change in Anxiety Level

研究概览

简要总结

This interventional study aimed to evaluate the effects of music therapy on anxiety and distress levels in patients with prostate cancer undergoing radionuclide therapy. A total of 60 patients who met the eligibility criteria were included in the study. Participants were assigned to either an intervention group or a control group.

Patients in the intervention group listened to music through headphones during the radionuclide treatment session, while patients in the control group received standard care without a music intervention. Music selections included various types of non-verbal music such as classical music, Turkish classical music, and other instrumental genres. Participants were allowed to select their preferred music from a predefined list.

Psychological distress and anxiety levels were assessed using the Distress Thermometer and the Hospital Anxiety and Depression Scale. Measurements were obtained before the treatment session and again after completion of the radionuclide therapy. The study evaluated whether listening to music during treatment could reduce anxiety and distress levels in patients receiving radionuclide therapy for prostate cancer.

详细描述

ntervention and Implementation Eligible patients undergoing radionuclide therapy in the nuclear medicine unit were evaluated for participation in the study. After receiving information about the study and providing written informed consent, participants were allocated to either the intervention group or the control group. The first eligible patient was assigned to the intervention group and the second patient to the control group. This sequence was continued until a total of 60 patients were included in the study.

Patients in the intervention group listened to music during radionuclide therapy, while patients in the control group received standard care without music intervention.

Music Intervention The music intervention consisted of listening to instrumental, non-verbal music through headphones during radionuclide therapy. Participants were allowed to choose their preferred music from a categorized list including classical music, Turkish classical music, Turkish makam music (Uşşak, Rast, Zirgüle, Hüseyni), jazz music, and other instrumental music genres.

Music playlists were prepared according to patient preferences prior to the treatment session. Participants were instructed on how to use the headphones and how to adjust the volume to a comfortable level. The music was played continuously during the treatment session for approximately 20-40 minutes.

Individual music preference was considered an important factor in the intervention. Therefore, patients were allowed to select music genres that they felt most comfortable with. Only instrumental or lyric-free music was used to minimize distraction and promote relaxation.

研究设计

研究类型
Interventional
分配方式
Non 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
Male
接受健康志愿者

入选标准

  • Male patients aged 18 years or older Patients diagnosed with prostate cancer Patients receiving the first course of radionuclide therapy Patients without hearing or speech problems Patients not receiving psychiatric treatment (not using anti-anxiety or antidepressant medications) Patients who are not in the terminal stage of the disease Patients who have and are able to use a smartphone with an Android or iOS operating system Patients who voluntarily agreed to participate in the study and provided written informed consent

排除标准

  • 未提供

研究组 & 干预措施

Music Therapy Group

Experimental

Patients in this group listened to self-selected instrumental music through headphones during radionuclide therapy. The music was chosen according to the patient's preference from a categorized list of non-verbal music types. Music was played for approximately 20-40 minutes during the treatment session.

干预措施: Music Therapy (Behavioral)

control group

No Intervention

Patients in this group received standard care during radionuclide therapy without any music intervention. Anxiety and distress levels were assessed using the same measurement tools as in the intervention group.

结局指标

主要结局

Change in Anxiety Level

时间窗: Baseline (before radionuclide therapy) and immediately after completion of each radionuclide therapy session, assessed over three treatment cycles

Anxiety levels were assessed using the Hospital Anxiety and Depression Scale (HADS). The scale was administered before radionuclide therapy and again after completion of the treatment session to evaluate changes in anxiety levels between the intervention and control groups.

次要结局

  • Change in Psychological Distress Level(Baseline (before radionuclide therapy) and immediately after completion of each radionuclide therapy session, assessed over three treatment cycles)

研究者

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

Esra Uslu Tanış

Principal Investigator

Dokuz Eylul University

研究点 (1)

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