Essay - Does Music Therapy Helps Perioperative Patients

Running head: ESSAY
Critical appraisal
Name of the Student
Name of the University
Author Note

1ESSAY
Introduction- 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:
P (population) Perioperative patients
I (intervention) Music therapy
C (comparison) Usual care
O (outcome) Reduced anxiety
Table 1- PICO format
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.

2ESSAY
1. 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).
2. 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).
3. 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

3ESSAY
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.
4. Blinding of participants- Yes. Blinding in clinical trials refers to the procedure
where the 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.
5. 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.
6. 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

4ESSAY
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.
7. 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).
8. 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.
9. 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

5ESSAY
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.
10. 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.
11. 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).
12. 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.
13. 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.

6ESSAY
Summary- 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.

7ESSAY
References
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Baldwin, L. (2018). Internal and External Validity and Threats to Validity. In Research
Concepts for the Practitioner of Educational Leadership (pp. 31-36). Brill Sense.
Barr, A. L., Knight, L., Franҫa-Junior, I., Allen, E., Naker, D., & Devries, K. M. (2017).
Methods to increase reporting of childhood sexual abuse in surveys: the sensitivity
and specificity of face-to-face interviews versus a sealed envelope method in
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Bringman, H., Giesecke, K., Thörne, A., & Bringman, S. (2009). Relaxing music as pre‐
medication 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., & Creswell, J. D. (2017). Research design: Qualitative, quantitative, and
mixed methods approaches. Sage publications.
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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. Trials, 18(1), 204.

8ESSAY
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9ESSAY
JBI Critical Appraisal Checklist for Randomized Controlled Trials
Reviewer Date
Author Year Record
Number
Yes No Unclear NA
1. Was true randomization used for assignment of
participants to treatment groups? □ □ □ □
2. Was allocation to treatment groups concealed? □ □ □ □
3. Were treatment groups similar at the baseline? □ □ □ □
4. Were participants blind to treatment assignment? □ □ □ □
5. Were those delivering treatment blind to treatment
assignment? □ □ □ □
6. Were outcomes assessors blind to treatment assignment? □ □ □ □
7. Were treatment groups treated identically other than the
intervention of
interest? □ □ □ □
8. Was follow up complete and if not, were differences
between groups in
terms of their follow up adequately described and
analyzed?
□ □ □ □
9. Were participants analyzed in the groups to which they
were randomized? □ □ □ □
10. Were outcomes measured in the same way for treatment
groups? □ □ □ □
11. Were outcomes measured in a reliable way? □ □ □ □
12. Was appropriate statistical analysis used? □ □ □ □
13. Was the trial design appropriate, and any deviations from
the standard RCT design (individual randomization,
parallel groups) accounted for in the
conduct and analysis of the trial?
□ □ □ □
Overall appraisal: Include □ Exclude □ Seek further info □