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临床试验/CTRI/2018/09/015801
CTRI/2018/09/015801已完成不适用

A Randomized Controlled Trial On The Effect of Indian Classical Music For Chemotherapy and Radiotherapy Induced Anxiety, Pain and Mood Disturbance in Head and Neck Cancer - A Pilot Study

Manipal Academy of Higher Education internal funding for research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Reduction of the chemotherapy- radiotherapy induced anxiety, pain and mood disturbance after listening to the Indian classical music.

研究概览

简要总结

This is a randomized controlled trial among patients who are treated with radiation therapy for diagnosed head and neck cancer at tertiary oncology care centre KMCH, Attavar in Mangalore, South India. Selection of specific “raga†would be according to the inherited knowledge prevailed in centuries in the Indian classical music. This study includes all the patients who were diagnosed with Head and neck squamous cell carcinoma and treated under chemotherapy and radiotherapy at Kasturba Medical College and Hospital. The diagnosis of Head and neck cancer established by histopathologic  study. Demographic details, clinical staging, comorbidity status, treatment, recurrence, follow up data, would also be analyzed along with music therapy outcome. This study excludes those patients who were less than 16 years of age, having hearing deficit, not suitable for CT-R and not willing to consent. Our objectives are to study the effect of specifically selected “raga†in Indian classical music in patients undergoing CT-RT (chemo-RT) for head and neck cancer, analyze the therapeutic use of specific “raga†in Indian classical music in cancer patients and to study the music therapy (specific “raga†in Indian classical music) outcomes. This study would probe into the therapeutic use of Indian classical music among all the head and neck cancer patients taking radiotherapy from the centers of analysis so that the fraction of patients getting this music therapy can be analyzed along. We also look forward to see whether the outcomes had changed with the music therapy which is serious concern in regard to the survival. We will analyze the cases and controls at 0th, 3rd and the 5th/7th week of Radiation using pretested semi-structured questionnaires (Hamilton anxiety rating scale, Hospital anxiety and depression scale and visual analogue scale for pain). The data will be analyzed using SPSS version 17. Results will be expressed in proportions and standard derivations. Chi-square test and t test will be used to test statistical significance.  P value of <0.05 will be considered significant.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients who are diagnosed with Head and neck cancer.
  • squamous cell carcinoma who are treated with chemotherapy an radiotherapy at Kasturba Medical College and Hospital.

排除标准

  • This study excludes patients who are less than 18 years of age, having a hearing deficit, not suitable for chemotherapy and radiotherapy and not willing to give consent.

结局指标

主要结局

Reduction of the chemotherapy- radiotherapy induced anxiety, pain and mood disturbance after listening to the Indian classical music.

时间窗: 0th 3rd and 5th week of study.

次要结局

  • Reduction of anxiety, pain and mood disturbance(0th,3rd and 5th week.)

研究者

发起方
Manipal Academy of Higher Education internal funding for research
申办方类型
Private medical college

研究点 (1)

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