The time around surgery often includes perioperative care for patients. The research by Gustafsson et al. (2019) points out the usual place of such operation as being a hospital or surgical center. This practice area was chosen because perioperative anxiety is often undertreated despite increased understanding of anxiety mechanisms and administration of anxiolytic medications. is. In a study by Ogba et al. (2019), they showed that music therapy can simulate the resting heartbeat, promoting relaxation. Articles were taken from the CINAHL electronic database, using search combinations like “music therapy,” “perioperative,” “anxiety,” and “management“; with Boolean operator pair “AND” and “OR.” (McGowan et al., 2016). After 2009 published randomized controlled trials are seen as suitable for selection. Using PICO, the development and definition of the foreground research question took place. PICO components are listed on the table provided.
The research question for article selection was: The JBI, a global member-based research and development organization, took on the challenge of investigating whether music therapy could help reduce anxiety in perioperative patients. Their study was titled “Relaxing music as a pre-surgery treatment: a randomized controlled trial.” Using the RCT checklist, we believe it to be relevant to the questions posed. Randomization – Yes. The significant variation within study participants across different comparison groups increases the risk of reduced internal validity. For a clinical research study, Treweek recommends randomizing participants so they have an equal chance of ending up in either the control or treatment group. Advance prediction of group assignment is not possible with successful randomization. Researchers randomly assigned 372 patients scheduled for elective surgery to two groups: Bringman et al. (2009) tested the efficacy of music therapy (treatment) in comparison to oral midazolam 0.05-0.1 mg/kg (comparison). This process helps to eliminate bias in assigning participants to treatment groups and also promotes direct comparisons of one treatment with another, leading to the establishment of one treatment being superior over the other. (Creswell & Creswell, 2017). After the patient agrees to participate in the study, the envelopes are opened, and intentional interference is prevented. (Barr et al., 2017).
Attribution Concealment – Yes. Researchers usually do not know beforehand what controls or treatments the assignment process will introduce as they assign patients. Investigators may face deliberate interference and manipulation despite knowing assigned study groups (Clark et al., 2016). Sealed envelopes suggest that the assignment instructions were hidden from the researchers until 372 patients were assigned to her two groups. By removing intuitive and other controls from researchers on group assignments during this specific trial (Bringman et al., 2009 ), its findings saw a significant improvement in reliability.
Basic functionality: Yes. Internal validity in research, as defined by Baldwin (2018), is related to the estimated truth of conclusions about causal relationships. The fact that different individuals are distributed among various groups increases chances for selection bias in a study and consequently creates a non-representative sample from the broader population being researched. There were no differences between participants in the music therapy and midazolam groups. (Bringman et al., 2009). Each participant was over 18 years old and had booked a short stay or scheduled surgery at Södertalje Hospital.
Blinding of participants – Yes. Clinical trials use blinding to regulate participant knowledge and ensure the exclusion of any information that could affect their results (Staudacher et al., 2017). Sealed envelopes ensured participants did not know which group they were a part of. This methodological feature increased both the validity and reduced bias in the results.
Blinding researchers – no. Participants in a control or treatment group may experience different behavior from administrators or researchers who know their assignment. There is a chance you might show them disrespectful behavior. Obligation to treat. This leads to skewed results in the process. Researchers were unable to remain quiet about the interventions made for each patient. Researchers could not determine the outcome because no evidence existed comparing midazolam and music therapy.
Blinding of outcome assessors – unclear. Do not let the person assessing the results know which group each study participant belongs to. Kennedy et al. (2017) propose that greater awareness of allocation is associated with a higher probability of manipulating results for reduced validation; this could be one reason for the observed effect. Survey results, heart rate, and blood pressure can be biased because the researchers did not mention that outcome assessors should be blinded to assigned treatment; therefore, the results are not reasonable.
Same treatment group – yes. ‘Cause’ should not be connected to ‘effect’ through selection bias or variations among participants. The existence of alternative treatments or exposures besides the “cause” impedes establishing a definitive association and biases the results. In the study, there were no differences between participants randomly assigned to music therapy and midazolam. In this study, patients in the first group were given CDs with different music genres, unlike the comparison group (Bringman et al. 2009).
Participant tracking – Yes. The follow-up period refers to the time between assigning a research participant to her two groups and the study’s conclusion. All 177 patients who received music were reported at the end of the study and not a single person from the group who had music therapy was lost during follow-up. Fifteen patients who received midazolam were part of the intervention, and nine dropped out; leaving 150 participants. With too short a follow-up period or loss of participants during it, the internal validity of a study will be compromised and results unsound. ITT analysis – No. A method used to assess the results of prospective randomized trials. All randomized participants are analyzed and considered according to their original group designations; regardless of whether or not they received any treatment (Lee et al., 2017). Of those 372 participants, the significant 36 exclusions caused a decreased interval between intervention and evaluation.
Similar outcome measures: Yes. After all participants received her two interventions, they were asked to complete the State Trait Anxiety Inventory (STAI StatSoft Inc.). , Tulsa, Oklahoma) (Bringman et al., 2009). This process reflects real-world clinical situations as it allows for protocol deviations and non-compliance. It also helped maintain the prognostic balance resulting from the initial random treatment assignment. Using STAI X-1 and measuring blood pressure and heart rate in all participants ensured that the internal validity of the study was intact.
Reliable outcome measurement – Yes. Since STAI 2019, results have also been measured in a reliable way).
Statistical analysis – Yes. The statistical design used was also appropriate, as ANOVA was useful for examining differences between and between groups, and Statistica was identified as important for data mining, data management, machine learning, and statistics.
Experimental design – Yes. The appropriateness of the study design can be attributed to the fact that it helped eliminate selection bias that could have distorted the results (Arbel, Nipoti, & Teh, 2019). Furthermore, his design, consisting of two groups of participants with similar characteristics, showed that relaxing music significantly reduced anxiety manifested during preoperative care compared to oral administration of midazolam. was also confirmed.
Blind the participants
The increased efficacy and lack of side effects of music therapy make preoperative relaxation music a good alternative to drug therapy (Bringman et al., 2009). The study results can be extrapolated to the local population, as all preoperative patients reported similar fears, regardless of the surgical procedure performed.
The perioperative period, type of surgery, complications, and the postoperative period should be included in informing patients about perioperative care. Measures aimed at reducing or eliminating postoperative pain are part of perioperative pain management. Anti-anxiety medications are used to alleviate the anxiety and fear that patients undergoing surgery often experience. Not many studies have compared the effects of music therapy to conventional drug therapy for preoperative, postoperative, or intraoperative anxiety. As an alternative treatment for anxiety reduction during perioperative care, relaxing music has little or no side effects and should be considered.
Arbel, J., Nipoti, B., Teh, Y. W. (2019). Sinica Statistics Preprint Number: SS-2015-0250R2.
Baldwin, L. (2018). Threats to internal and external validity and validity. Research concepts for educational leadership practitioners (pp. 31-36). Great sense.
Barr, A. L., Knight, L., Frana Jr., I., Allen, E., Naker, D., and DeVries, K. M. (2017). Methods to increase reporting of child sexual abuse in research: Sensitivity and specificity of face-to-face interviews compared to sealed envelope methods among Ugandan primary school students. BMC International Health and Human Rights, 17(1), 4.
Bringman, H., Giesecke, K., Thörne, A., & Bringman, S. (2009). Relaxing music as preÃ¢â‚¬ÂÂmedication before surgery: a randomised controlled trial. Acta Anaesthesiologica Scandinavica, 53(6), 759-764.
Clark, L., Fairhurst, C., & Torgerson, D. J. (2016). Allocation concealment in randomised controlled trials: are we getting better?. Bmj, 355, i5663.
Creswell, J. W. & Cresswell, J. D. (2017). Research design: Qualitative, quantitative, and mixed methods approaches. Sage Publishing.
Gustafsson, U. O., Scott, M. J., Hubner, M., Nygren, J., Demartines, N., Francis, N., … & de Boer, H. D. (2019). Guidelines for perioperative care in elective colorectal surgery: Enhanced Recovery After Surgery (ERAS®) society recommendations: 2018. World journal of surgery, 43(3), 659-695.
Kennedy, A. D., Torgerson, D. J., Campbell, M. K., & Grant, A. M. (2017). Subversion of allocation concealment in a randomised controlled trial: a historical case study. Trial, 18(1), 204.
Lee, M. W., Raman, S. S., Asvadi, N. H., Siripongsakul, S., Hicks, R. M., Chen, J.,… & Agopian, V. G. (2017). Radiofrequency ablation of hepatocellular carcinoma as bridging therapy to liver transplantation: a 10-year intention-to-treat analysis. Hepatology, 65(6), 1979-1990.
McGowan, J., Sampson, M., Salzwedel, D. M., Cogo, E., Forerster, V. & Lefebvre, C. (2016). PRESS Peer Review of Electronic Search Strategies: Guidance Statement 2015. Journal of Clinical Epidemiology, 75, 40-46.
Ogba, F.N., Ede, M.O., Onyishi, C.N., Agu, P. U., Ikechukwu Ilomuanya, A.B., Igbo, J.N., … & Omeke, F.C. (2019). Effects of music therapy with relaxation techniques on stress management as measured by the Perceived Stress Scale. Medicine, 98(15).
Staudacher, H. M., Irving, P. M., Romer, M.C., and Whelan, K. (2017). Control groups, placebos, and the challenges of blinding in clinical trials of nutritional interventions. Journal of the Japanese Society of Nutrition, 76(3), 203-212.
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