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临床试验/CTRI/2017/09/009919
CTRI/2017/09/009919招募中不适用

Effect of Music Therapy on bio-physiological and psychological outcomes during chemotherapy among patients with cancer.

Syed Imran1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
bio-physiological outcomes such as Temperature, Heart rate, blood pressure, Salivary cortisol and salivary amylase levels.

研究概览

简要总结

The purpose of the study is to make the patients with cancer feel comfortable and to improve the quality of life to some extent in terms of bio-physiological (body temperature, pain, blood pressure, heart rate, salivary alpha amylase, salivary cortisol) and psychological (anxiety, fatigue, quality of life/satisfaction) outcomes by providing music only during the chemotherapy receiving for the first time.

Following hypothesis will be tested at 0.05 level of significance H1:       The mean post-test scores of bio-physiological outcome (Body temperature) will be significantly lower than the mean pretest score.

H2:       The mean post-test scores of bio-physiological outcome (Blood pressure) will be significantly lower than the mean pretest score.

H3:       The mean post-test scores of bio-physiological outcome (Heart rate) will be significantly lower than the mean pretest score.

H4:       The mean post-test scores of bio-physiological outcome (salivary amylase) will be significantly lower than the mean pretest score.

H5:       The mean post-test scores of bio-physiological outcome (Salivary cortisol) will be significantly lower than the mean pretest score.

H6:       The mean post-test scores of psychological outcomes (Anxiety) will be significantly lower than the mean pretest score.

H7:       The mean post-test scores of psychological outcomes (Fatigue) will be significantly lower than the mean pretest score.

H8:       The mean post-test scores of psychological outcomes (Quality of life)  will be significantly higher than the mean pretest score.

H9:       There will be significant association between bio-physiological outcomes and the selected demographic variables.

H10:      There will be significant association between psychological outcomes and the selected demographic variables.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Having II and III stage of cancer
  • Willing to participate in the study
  • Available at the time of date collection.

排除标准

  • Having hearing problems.
  • Having head and neck cancer
  • Having diabetes, hypertension and thyroid problems.

结局指标

主要结局

bio-physiological outcomes such as Temperature, Heart rate, blood pressure, Salivary cortisol and salivary amylase levels.

时间窗: on the first day of chemotherapy cycle

psychological outcomes such as anxiety and quality of life

时间窗: on the first day of chemotherapy cycle

次要结局

  • bio-physiological outcomes such as Temperature, Heart rate, blood pressure, Salivary cortisol and salivary amylase levels.(psychological outcomes such as anxiety and quality of life)

研究者

发起方
Syed Imran
申办方类型
Other [self]

研究点 (1)

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