The Effect of Music Therapy on the Radiotherapy Experience of Cancer Patients Undergoing Radiotherapy: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in Anxiety Level (STAI-SF)
研究概览
简要总结
The goal of this randomized controlled clinical study is to learn about the effects of music therapy on anxiety, stress, pain, and patient satisfaction in cancer patients who are newly starting radiotherapy (radiation treatment).
The main questions it aims to answer are:
Can music therapy lower the levels of anxiety and stress in patients receiving radiotherapy? Can music therapy improve the pain felt during the radiotherapy experience and overall satisfaction? Researchers will compare patients receiving standard radiotherapy (control group) with patients receiving music therapy alongside their radiotherapy (experimental group).
Participants (72 total) will:
Be 18 years and older and newly starting curative radiotherapy. Answer short surveys (STAI-SF, SDT, VAS) to measure their anxiety, stress, and pain levels before and after treatment.
Participants in the experimental group will receive a 15-20 minute music therapy session consisting of meditative and instrumental music during their first radiotherapy session.
This study aims to provide reliable data to guide clinical practice by showing whether music therapy offers a multifaceted approach to managing the psychological and physical challenges associated with cancer treatment.
详细描述
This study is a single-blind randomized controlled trial 20202020evaluating the effect of music therapy in managing the emotional and physical difficulties experienced by cancer patients who are newly starting curative radiotherapy (RT).Study Site: The study will take place at the Kocaeli University Hospital Radiation Oncology Unit.Objectives: The primary aim is to examine the effect of music therapy on anxiety, stress, pain, and patient satisfaction, and to determine how it can improve the RT experience.Intervention Application:Timing and Duration: Music therapy will be administered during the first RT session in sessions lasting 15-20 minutes. (Literature reports that $<20$ minutes reduces anxiety ).Provider: The intervention will be administered by a certified music therapist. Music Selection: Patients will be asked to choose music that has a meditative effect, is instrumental (without lyrics), and lacks peaks (sudden attacks), based on their preference and inclination. The music options provided will include Far Eastern music, music accompanied by a light-beat rhythm instrument (bendir), Ney-heavy Mesnevi music with meditative effects, and meditative Saba makam music.Listening Method: The patient's selected music will be played via headphones for 15 minutes before the session, and as ambient listening during the session. For patients with head and neck or brain cancer, only ambient listening will be used during the procedure for consistency.Data Collection and Timeline:Measurement Location: Measurements will be taken by researchers at the Kocaeli University Radiation Oncology Unit.Study Duration: The study starts on December 1, 2025, and ends on January31, 2026, with a total duration of 7 months.
Statistical Analysis
The collected data will be analyzed using the following methods: Between-group comparisons: Independent Sample T-test or Mann-Whitney U test37.Pre-post changes: Repeated Measures ANOVA.The significance level is set at $p<0.05.
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
- 否
入选标准
- •Must be a cancer patient 18 years of age or older.
- •Must be newly starting curative external radiotherapy.
- •Must volunteer to participate in the study and sign the Informed Consent form.
排除标准
- •Having an advanced stage psychiatric disorder (e.g., schizophrenia).
- •Having hearing loss.
- •Having a prior history of an adverse reaction to music therapy.
- •Receiving radiotherapy for palliative (symptom relief) purposes.
- •Having received radiotherapy previously (for reasons such as brachytherapy, a different type of cancer, or recurrence).
研究组 & 干预措施
Control Group (Standard Care Arm)
Description: Consists of patients receiving curative radiotherapy (RT) who receive only the standard radiation oncology care as per hospital protocol during their treatment.
干预措施: Standard Care (in control arm) (Other)
Music Therapy Group (Experimental Arm)
Description: Consists of patients receiving curative radiotherapy (RT) who receive the music therapy intervention in addition to standard care to improve their radiotherapy experience.
干预措施: Music Therapy (Other)
结局指标
主要结局
Change in Anxiety Level (STAI-SF)
时间窗: mmediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).
ssessment of the effect of the music therapy intervention on the anxiety levels of cancer patients receiving curative radiotherapy, using the State-Trait Anxiety Inventory-Short Form (STAI-SF). The measured difference will be compared between the intervention group and the control group.
Change in Stress Level (SDT)
时间窗: Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).
Assessment of the effect of the music therapy intervention on the general distress/stress levels experienced by cancer patients receiving curative radiotherapy, using the Symptom Distress Thermometer (SDT). The measured difference will be compared between the intervention group and the control group.
Change in Anxiety Level (STAI-SF)
时间窗: mmediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).
ssessment of the effect of the music therapy intervention on the anxiety levels of cancer patients receiving curative radiotherapy, using the State-Trait Anxiety Inventory-Short Form (STAI-SF). The measured difference will be compared between the intervention group and the control group.
Change in Stress Level (SDT)
时间窗: Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session (Post-test).
Assessment of the effect of the music therapy intervention on the general distress/stress levels experienced by cancer patients receiving curative radiotherapy, using the Symptom Distress Thermometer (SDT). The measured difference will be compared between the intervention group and the control group.
次要结局
- Change in Procedural Pain Level (VAS)(Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session)
- Patient Satisfaction Level (VAS)(Immediately after the end of the radiotherapy session (Post-test).)
- Change in Procedural Pain Level (VAS)(Immediately before the start of the radiotherapy session (Pre-test) and immediately after the end of the radiotherapy session)
研究者
Ünal Önsüz
Lecturer, PhD
Kocaeli University