A Randomized Clinical Trial by Li and Yan - Article Example

Critical Review of a Journal Article Student’s Name Institution Affiliation Overview of the Research Design In their research, Li, Zhou and Yan (2012) assessed the “impacts of music therapy on anxiety of breast cancer patients after radical mastectomy” in Chinese patients. The authors noted that there is inadequate evidence on the issue and hence the study was meant to provide further evidence using a randomized clinical trial. The researchers used a randomized control clinical trial to collect data. The clinical trial was undertaken “with a between group comparison of female breast cancer patients” (Li et al., 2012, p. 1147). The intervention group received both the regular nursing care as well as music therapy while the group being controlled only received the standard nursing care. The researchers used “Hall’s Core, Care, and Cure Model-based” clinical trial with 121 female patients of breast cancer for a period of nine months. They randomly allocated patients in the experimental group as well as the control group. The randomized control clinical trial was suitable for this research as it randomized the breast cancer patients in unbiased way in an attempt to assess the impacts of the music therapy intervention. Randomizing the subjects to trial groups also facilitated statistical analysis. The research design builds a strong argument for music therapy in treatments, which would not have been well substantiated by other research methods. DiCenso, Guyatt, and Ciliska (2005) argued that the power of randomization in randomized control trials is that experimental and control groups are likely to be balanced with regard to both unknown and known outcome determinants. Sampling The study participants were female breast cancer patients recruited from an oncology center of a general hospital in Xian, China. They were patients who were admitted in the hospital and the researchers recruited a convenient sample of the patients. The inclusion criterion was- female of ages 25-65 with a pathological breast cancer diagnosis and those needing a radical mastectomy (with extensive radical mastectomy (ERM) as well as modified radical mastectomy). The exclusion criterion was - patients allergic to sound or those with voice epilepsy sensitivity or those who did not prefer listening to music. The researchers recruited 120 female breast cancer patients. It is important to have these criteria identified before recruitment, as they are a means of establishing precision in the study. Polit and Beck (2008) noted that the inclusion and exclusion criteria have implications for the interpretation and generalizability of the findings. They also relate to the objective of transparency, which is a critical general aspect to consider- they should thus be explicit before recruitment so that a reader, could after performing the same search as the researcher, come to the same conclusion regarding the participants who should be included in the study. A computer program was used to produce 120 random numbers; this was the randomization procedure of the study. The 120 patients were allocated randomly to either the investigational group (n=60) or the control subject (n=60). The researchers calculated the size of the sample founded on state anxiety factors, which was measured using a State Anxiety Inventory (SAI) in other interrelated research. The researcher noted that one hundred patients (fifty in every study group) were required to note the five state anxiety score differences after calculation. This was at a power of 80% and at 5% statistical significance level. The researchers increased the sample size to one twenty to allow a twenty percent dropout rate. The randomization procedure was appropriate as it was a rapid procedure and it safeguarded the integrity of the procedure as intentional or unintentional biases did not influence the allocation process (Crosby, DiClemente, & Salazar, 2011). The participants in the experimental group received music therapy from the researchers in addition to the standard nursing care, which consisted of chemotherapy nursing care and Perioperative breast care. The control group just received the normal usual care and they did not receive music therapy or information about it. Data Collection The independent variable in this study was music therapy whereas the dependent variable was the anxiety level of the study participants. The independent variable is the cause whereas the dependent variable is the effect. In this case, music therapy was the cause while anxiety level was the effect. Essentially, research examines the impact of an independent variable on a dependent variable (Babbie, 2008). The dependent variable is what the researcher wishes to explain and in this study it is the anxiety level. The instruments used to collect data were a State Anxiety Inventory (SAI) and a standardized questionnaire for collecting demographic data. The questionnaire consisted of fifteen questions such as age, age when participant got breast cancer, marital status, monthly income, residence, educational level, and occupation. The SAI consisted of a twenty-item scale devised to evaluate the anxiety levels in the patients. Both the participants in both groups completed the questionnaires and pretest of anxiety level was undertaken before radical mastectomy. The researchers measured the state apprehension score at pretest period (the day prior to the radical mastectomy). They also undertook two other tests after the mastectomy- before the participants were released from the hospital, and after their admission in the hospital for chemotherapy (the second post-test and third posttest). Because of the different chemotherapy methods, the research set the intervals between the different tests at 14, 21, and 28 days. Data collectors asked all the participants the questionnaire items and they completed the questionnaires for them. They were trained on the best way to complete the questionnaire and they did not have any information on group allocation. The key endpoint was the state anxiety scores during the follow-up visits. Reliability refers to the degree to which research instruments generate consistent, stable, and repeatable data or results after repeated trials. Reliability is ensured through testing instrument stability over time. In this study, reliability for the questionnaire was not established whereas that of the SAI was established using the Cronbach’s Alpha reliability coefficient which was 0.90 in the clinical trial. Validity refers to the extent who which an instrument measured what it was meant to measure. The researchers partly prove validity of the study, there were no measures taken to ensure the validity of the questionnaire however the validity of the SAI was established through generating the test-retest coefficient of the previous studies. Results Differences in outcomes were identified between the intervention and control groups. The means state apprehension scores in the experimental sample were statistically considerably lesser relative to those of the control sample at all the three tests after treatment. According to Li et al. (2012, p. 1150), “The mean difference between experimental and control group together with 95% confidence interval was –4.57 (-6.33, -2.82), -8.91 (-10.75, -7.08) and -9.69 (-11.52, -7.85) at the 1st post-test, 2nd post-test and 3rd post-test respectively”. The probability value (P-value) for the interaction trial was Read More