Music Therapy for Perioperative Anxiety: A Randomized Controlled Trial

Randomisation

Perioperative care generally refers to the care delivered to patients, prior to and following a surgery. It generally takes places in hospitals or surgical centres (Gustafsson et al., 2019). This area of practice has been selected owing to the fact that regardless of the enhanced understanding of the mechanism of anxiety and administration of antianxiety drugs, perioperative anxiety is commonly undertreated. Music therapy has been found to promote relaxation by mimicking the heart during resting stage (Ogba et al., 2019). The article had been selected from the electronic database of CINAHL by using search terms like ‘music therapy’, ‘perioperative’, ‘anxiety’, and ‘management’ that were combined using boolean operators ‘AND’ and ‘OR’ (McGowan et al., 2016). Randomised controlled trials published on or after 2009 were considered eligible. The PICO format was used for developing the foreground research question and the table given below highlights the different PICO components

The research question that helped in article selection was: ‘Does music therapy helps to alleviate anxiety for perioperative patients?’ This assignment will contain a critical appraisal of an article titled ‘Relaxing music as pre-medication before surgery: a randomised controlled trial’ that was found relevant to the question given above, based on the Joanna Briggs Institute (JBI) checklist for RCTs since it is a world-wide, membership founded research and development association.

Randomisation- Yes.Presence of variations between research participants allocated to different comparison groups acts as a major risk to the internal validity. Randomisation refers to assigning participants to a clinical trial group such that all participants have identical chance of getting allocated to either control or treatment group (Treweek et al., 2018). Therefore, successful randomisation necessitates that the assignment to groups cannot be anticipated in advance. The researchers randomised 372 patients who were scheduled for elective surgery to two groups namely, music therapy (treatment) and 0.05–0.1 mg/kg of oral midazolam (comparison) (Bringman et al., 2009). This process eliminated bias in assignment of participants to treatment group and also facilitated direct comparison of one treatment to another, thereby establishing superiority of one (Creswell & Creswell, 2017). Though the envelope is opened only after a patient has agreed to participate in the trial, the procedure is subject to deliberate meddling since the researchers can open some envelopes, following which they can assign patients to the anticipated treatment (Barr et al., 2017). 

Concealment of allocation- Yes. It generally comprises of processes that avert the investigators allocating the patients from understanding before apportionment, which control or treatment is next in the assignment procedure. If the investigators are aware of the groups where the participants are assigned, there remains a risk of purposeful and deliberate intrusion, thereby distorting the results (Clark, Fairhurst & Torgerson, 2016). The use of sealed envelope suggests that the allocation sequence was concealed from the researchers until the moment of assigning the 372 patients to the two groups that have been mentioned above. Therefore, this step prevented the researchers from instinctively or otherwise governing which patients will be allocated to the control or the intervention group, thus increasing reliability of the results (Bringman et al., 2009).

Concealment of allocation

Baseline characteristics- Yes. According to Baldwin (2018) internal validity in a research refers to the estimated truth about inferences, in relation to causal effect. Presence of differences between the participants assigned to each group increases the risk of selection bias in the trial, thus confirming that the research sample is not representative of the wider population that is intended to be explored. Moreover, if variances exist between the participants recruited to the control and comparison groups, the ‘effect’ cannot be accredited to the possible ‘cause’. There was no difference between the participants assigned to the music therapy and midazolam group (Bringman et al., 2009). All participants were aged more than 18 years and had been booked for a short-stay or elective surgery at the So¨derta¨lje Hospital.

Blinding of participants- Yes.Blinding in clinical trials refers to the procedure wherethe research participants are prohibited from knowing particular information that may someway control them, thus affecting the results (Staudacher et al., 2017). The participants were also not aware of the group to which they had been assigned since sealed envelopes were used. This methodological feature helped in increasing validity of the findings, while reducing bias.

Blinding of researchers- No.Under circumstances when the investigators or people delivering interventions are alert of the allocation of participants to the control or the treatment group, there occurs a risk that the investigators might behave in a different way with the research participants, or might treat them in varied ways, in comparison to circumstances when they are not conscious of the treatment assignment. This distorts the results of the trial. It was not possible to make the researcher unaware of the intervention given to each patient. However, non-existence of evidence that compared midazolam with music therapy prevented the researchers from knowing the results.

Blinding of outcome assessors- Unclear.It is imperative to keep the outcome assessors unaware of the groups to which research participants are assigned. This can be accredited to the fact that knowing about allocation often increases the likelihood of deliberately measuring outcomes in ways that decrease the validity of the results (Kennedy et al., 2017). Though the researchers did not mention about blinding outcome assessors to the assigned treatment, the result questionable to be reasonable since the questionnaire scores and the heart rate and blood pressure were prone to bias.

Identical treatment groups- Yes. With the aim of associating the ‘cause’ to the ‘effect’, there must be no selection bias or variation between the participants, assigned to different groups. Presence of other treatment, or exposure, apart from the ‘cause’ prevents establishment of a clear association, thus distorting the results. There was no difference between the 372 participants randomised to the music therapy and midazolam group. While those in the former, patients were provided with CDs containing different music genres, those in comparison group were administered 0.1 mg/kg body weight or 0.05 mg/kg body weight, for age less than 60 and more than 60 years, respectively (Bringman et al., 2009).

Baseline characteristics

Follow-up of participants- Yes. Follow-up generally refers to the duration from the time of random assignment of research participants to the two groups, till the end of the research. The researchers did not lose any patient allocated to music therapy during follow-up period and all 177 who received music were accounted at the end of the study. However, of the 159 patients who received midazolam, nine discontinued the intervention, thus accounting for 150 at the end of the trial. If the follow-up period is inadequate or participants get lost during follow-up, the internal validity of the research gets compromised and the results are not considered reliable.

Intention to treat (ITT) analysis- No.It refers to the method commonly used for analysing the findings in prospective randomised trials where all randomised participants are involved in the statistical analysis and examined according to the group where they had been initially assigned, notwithstanding the treatment they have been subjected to (Lee et al., 2017). Of the 372 recruited participants, exclusion of 36 due to early operation significantly decreased the time between intervention and assessment, thus averting heterogeneity.

Similar outcome measures-Yes.After subjecting all participants to the two interventions, all of them were asked to fill out the State Trait Anxiety Inventory (STAI X-1) form, the responses of which were analysed using two-way analysis of variance (ANOVA) and Statistica (v 7.1, StatSoft Inc., Tulsa, OK) (Bringman et al., 2009). This process reflected the practical clinical circumstance since it admitted protocol deviations and noncompliance. It also helped to maintain a prognostic balance, originated from the initial random treatment allocation. Use of STAI X-1, and measurement of blood pressure and heart rate for all participants ensured that the internal validity of the trial was not threatened.

Reliable outcome measures- Yes. The outcomes were also measured in a reliable way since STAI X-1 encompasses a 4-point likert scale and is a psychological inventory having 40 questions that has been found effective in determining both trait anxiety and state anxiety (Stephenson-Brown et al., 2019).

Statistical analysis- Yes. The statistical design used was also appropriate since ANOVA helps in exploring the variations between and among groups, and Statistica has been identified significant in data mining, data management, machine learning, and statistics

Trial design- Yes. The appropriateness of the study design can be accredited to the fact that the design helped in eliminating selection bias that might have skewed the findings (Arbel, Nipoti & Teh, 2019). Moreover, the design comprised of two participant groups having similar characteristics,also confirmed that when compared to oral administration of midazolam, anxiety manifested during preoperative care significantly decreases by relaxing music.

Blinding of participants

Increased effectiveness of music therapy and non-existence of any adverse impact makes preoperative relaxing music a good substitute for pharmacotherapy (Bringman et al., 2009). The study findings can be applied to local population since all preoperative patients report similar anxiety, regardless of the surgical procedure being performed.

Conclusion-

Perioperative care encompasses educating the patient about the perioperative period, the type of surgery, complications (if any), and the postoperative period. Perioperative pain management comprises of actions that are envisioned to decrease or eradicate postoperative pain, prior to discharge of the patient. Patients awaiting surgery generally suffer from terror and anxiety, which can be effectively stopped through the administration of anxiolytic drugs. Not many studies had been conducting comparing the impacts of music therapy with usual pharmacotherapy, in relation to preoperative, postoperative or intraoperative anxiety. In this RCT, relaxing music was found effective in decreasing anxiety amid patients in perioperative care, therefore can be regarded as an alternative treatment, owing the presence of little or no adverse effects.

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