¶ … clinical trial report regarding the effects of music therapy on female breast cancer patients following radical mastectomy. In this review, the article would be examined on the basis of its sampling unit, measurement methods, process of data collection and data analysis, researcher's interpretation of findings, the limitation of the study and its implication in clinical practice, its significance as well as the scope for further investigation.
The present study uses stratified random sampling, also known as proportional random sampling, of probability sampling technique wherein subjects are initially divided in groups on the basis of age, gender, condition etc. A final list or sub-group can then be chosen from the main group (as one hundred and twenty female patients suffering from breast cancer, aged between 25 to 65 years of age, have been chosen randomly here). The sample specifically took account of patients who required radical mastectomy, including modified radical mastectomy and extensive radical mastectomy (Li, Zhou, Yan, Wang & Zhang, 2012, p. 1147). This technique is very effective to study a particular group of people from the main population. It is also considered better than simple random sampling because it warrants more accurate statistical outcomes. The advantage of choosing a sub- group randomly, as chosen 120 random numbers through a computer program in the present case, is the absence of sampling bias (Explorable.com, 2009).
Sample size plays an active role in yielding accurate results as sample size is directly related to power. As stated by Suresh, Thomas and Suresh, "ceteris paribus, the bigger a sample, the higher the statistical power" (Suresh, Thomas & Suresh, 2011). The randomly selected 120 patients were further distributed randomly into two groups of 60 each; an experimental and a control group. As calculated earlier, a minimum number of 50 patients in each group are required to detect the difference of five state anxiety score with a power of 80% at the 5% level of statistical significance. Therefore, a size of 120 patients was a careful attempt, keeping in mind a 20% drop-out rate, as the detection might have been affected simply because not enough patients were selected (Li et al., 2012, p. 1148).
Being an interventional trial, as it uses a new technique of introducing music therapy, (Bos, 2007) this study considers the age group between 25-65 years of female patients suffering from breast cancer and required radical mastectomy as its inclusion criteria. While the exclusion criteria included patients who had voice sensitivity of epilepsy, or sound allergy, or simply did not prefer listening to music, (Li et al., 2012, p. 1148) none of the patients were lost in first post-test from either group. The second and third post-test observed a loss of 6 patients from the experimental group and 9 patients from the control group, respectively. Thus, a total of 15 patients were lost, thereby giving an attrition rate of 12.5% (Li et al., 2012, p. 1150).
Regarding ethical consideration, the study has been reviewed and acquired the approval of the appropriate Human Research Ethics Committee. All the participants were thoroughly explained to the process before participating and they gave written informed consent before participating voluntarily (Li et al., 2012, p. 1149). The setting of this clinical trial is the oncology center of a general hospital in Xian, China, which is very appropriate for the introduction of this new therapy under controlled circumstances. However, the effects of music therapy in an outpatient setting or external setting are still unknown (Li et al., 2012, p. 1147).
3. Measurement Methods
The instruments used in this study are a standardized demographical data questionnaire, which comprised of a total of 15 categories, namely: age, residence, educational level, occupation, income, marital status and age of first patients suffering from breast cancer, etc.; and the State Anxiety Inventory (SAI), which was used in its Chinese version for the evaluation of anxiety in patients in the present study. SAI's inclusion of a 20-item scale was planned to measure anxiety as an emotional state through a four-point Likert format, where one stands for not at all, and four for very much so. This is because SAI is one of the most widely used instruments to measure anxiety, in research and clinical settings and with Chinese populations. Anxiety score range varies from 20-80; the greater the anxiety, the higher the score. For example, low anxiety ranges between 20 to 39, moderate anxiety 40 to 59 and high anxiety ranges from 60 to 80. The validity coefficient of SAI is 0.88 and the test-retest reliability coefficient is 0.72. However, the effect of the application of Chinese version of SAI to many studies resulted in a test-retest coefficient of 0.88 while the Cronbach's Alpha...
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