Abstract
Background
Non-pharmacological interventions such as music are being increasingly used in clinical settings.
Objective
To assess the effects of music on patients undergoing total knee replacement (TKR) surgery under subarachnoid anesthesia.
Methods
This randomized controlled trial examined participants (45/group) in a music and non-music group. Anxiety was measured in both the groups using (1) the adapted hospital anxiety and depression scale (HADS), (2) Spielberger state trait anxiety inventory (STAI-S), (3) visual analog scale (VAS), (4) cortisol levels, and (5) blood pressure. Music was delivered using an MP3 player and headphones. Hemodynamic data was collected before, during, and after music therapy. Cortisol and stress levels were measured postoperatively. VAS was assessed 30 min before surgery, 30 min after the administration of anesthesia, and 30 min after the surgery ended in the recovery room to obtain comparative data on pain levels at 3 different phases using a numeric rating scale.
Results
Changes in the mean VAS scores from the pre-to postoperative phase were significantly different between the music and non-music groups (p = .001). The mean (±standard deviation [SD]) HADS and STAI-S scores of the non-music group were higher than those in the music group (HADS:15.58 ± 2.231 vs 11.91 ± 3.218; STAI-S: 54.04 ± 2.899 vs 48.87 ± 4.595). There were significant differences in the mean systolic and diastolic blood pressure and mean heart rate between the groups based on time (both, p < .001). Correlation regression analysis for the cortisol level revealed a certain relationship between age and cortisol level (p < .05).
Conclusions
These results suggest that music can reduce patients’ anxiety level in the operating room. Studies on music therapy for patients undergoing lower limb orthopedic surgery, especially under subarachnoid anesthesia, are extremely limited. Therefore, this study can serve as a reference regarding the application of music therapy in the medical field.
Introduction
Music is a non-pharmacological intervention that can alleviate stress in various clinical situations. Studies involving music interventions in the field of obstetrics have demonstrated that music improved the ability to relax during delivery and reduced anxiety levels. 1 Music therapy has also been reported to decrease the pain scores of a patient receiving standard palliative care for pain management. 2
Music is effective in reducing anxiety and pain during invasive procedures. Listening to music before and during procedures can help reduce anxiety and pain and decrease systolic blood pressure and heart rate. It can also be employed to promote recovery. 3 A research study found that when music was used preoperatively, patients undergoing day-care surgery had significantly reduced heart rates, respiration rates, and blood pressure. 4
The calming effects of music can be measured in patients after as little as 30 min of therapy. In a previous study, patients showed reduced heart rate, diastolic pressure, and systolic pressure. 5 Furthermore, another study reported that listening to music had a significant impact on psychological features of anxiety in the pre-procedural state. 6
However, to the best of our knowledge, the effects of music therapy on patients undergoing lower limb surgery under subarachnoid anesthesia in an orthopedic operating room have not been studied. Therefore, this study aimed to assess the effects of music therapy on patients undergoing lower limb orthopedic surgery under subarachnoid anesthesia based on (1) the adapted hospital anxiety and depression scale (HADS) scores, (2) Spielberger state trait anxiety inventory (STAI-S) scores, (3) visual analog scale (VAS) scores, (4) cortisol levels, and (5) blood pressures.
Materials and methods
This study was approved by the relevant Institutional Review Board. This randomized controlled trial enrolled patients with no history of surgery who were undergoing lower limb operations in the orthopedic operation room under subarachnoid anesthesia. The patients were divided into a “music group” and “non-music group.” Music was delivered using an MP3 player and headphones. For patients in the music group, hemodynamic data were collected during three sessions: 1st session = 30 min preoperatively in the orthopedic ward before the patients were sent to the operating room (baseline), 2nd session= 30 min after the administration of regional anesthesia, during which MP3 players and headphones were provided to patients to listen to music, and 3rd session =30 min after 2nd session stopped (the music therapy ended). Patients in the control group (no music) received standard nursing care during surgery for the 3 sessions of the same duration as the music group. Serum cortisol level was recorded for each group in the recovery room (postoperative area), and the findings were compared to determine the effect of music therapy based on an increase or decrease in the serum cortisol levels. Interview sessions were conducted after the patients returned to the wards to record HADS and State Trait Anxiety Inventory-Spielberger (STAI-S) scores. The STAI-S is rated on a 4-point scale and can be used to diagnose anxiety based on the total score calculated, with the highest score showing high anxiety and the lowest score indicating low anxiety. The assessment of VAS was performed 30 min before surgery in the orthopedic ward, 30 min after the administration of anesthesia, and 30 min after the surgery ended in the recovery room to obtain comparative data on pain levels at 3 different phases using a numeric rating scale.
Inclusion and exclusion criteria
Patients were included in analysis if they (1) were >18 years old, (2) were bilingual, (3) received regional anesthesia (subarachnoid block), (4) were undergoing Total Knee Replacement (TKR) surgery, (5) had an operation duration of at least 1.5 h and (6) had no history of surgery (7)no history of anxiety disorders. Patients were excluded if they (1) received general anesthesia, (2) refused to participate, (3) were senile, (4) had dementia, (5) were aggressive and un-cooperative, or (6) received sedation/analgesics or both.
Sample size calculation
The sample size was estimated using the G-power Sample Size Calculation 3.010 software. Considering a power of 0.8, α of 0.05, and effect size of 0.3 with a two-tailed test, we found that the minimum sample size needed was 90 patients. Considering the intention to treat and based on the double parallel arm equality, the experimental and control groups included 45 patients each. The experimental and control group patients were randomized using the randomizer.org software. Lastly, all the data were coded and compiled into Microsoft Excel 2010 spread sheet and then all the data were also analyzed using SPSS Version 21.0 (frequency, post-hoc test, correlation regression analysis)
Study design and population
The subjects or respondents were selected from a pool of orthopedic patients who were undergoing regional anesthesia (subarachnoid block or epidural block) and had no prior history of surgery. All patients were assessed between December 2017 and February 2019.
Data collection procedure
Questionnaire and consent forms were given to respondents who fulfilled the inclusion criteria. Informed consent was obtained. Before the procedure, each respondent was assigned a code number to protect their confidentiality. At the ward, hemodynamic data (blood pressure, heart rate, and respiration rate) were collected for 30 min—the 1st session. Patients were then transported to the orthopedic operating room. The anesthetic nurse working on the case was responsible for opening an envelope and following the instruction contained within. Patients were provided the opportunity to choose the type of song they preferred, with options including music of different languages and genres (pop-rock, romantic, and religious). The genres offered were chosen because of their popularity under the general population.
If the envelope’s instruction stated, “provide music therapy,” the nurse placed headphones on the patient for 30 min (2nd session), keeping the headphone on the patient for 30 min after the administration of regional anesthesia and then took off the headphone once the 30 min had elapsed. Routine nursing care was simultaneously continued. The 3rd session was important to evaluate hemodynamics to determine any changes in heart rate and blood pressure in the music group after the music ended.
If the instruction in the envelope stated, “no music therapy,” the anesthetic nurse would inform the patients that they would not receive any music therapy. Patients in this control group (non-music group) received routine nursing care for all 3 sessions during the operation (same duration as music group with each session = 30 min). Serum cortisol levels were measured in both groups using 5 mL of serum collected after the patients arrived at the recovery bay. The self-answered questionnaire (adapted HADS) and interview sessions for the STAI-S were held in the wards postoperatively.
Statistical analysis
All the data were coded and compiled into a Microsoft Excel 2010 spread sheet. Then, all the data were statistically analyzed using SPSS Version 21.0. The following tests were conducted: descriptive analysis (mean values), paired t-test, independent t-test, repeated measure analysis, and regression analysis.
Results
The music and non-music groups consisted of 28 (62.2%) and 29 (64.2%) men, respectively, and 17 (37.85%) and 16 (35.6%) women, respectively. The distribution of age in the music group was as follows: 33.3% (15 respondents), 21–40 years; 35.6% (16 respondents), 41–60 years; and 31.1% (14 respondents), >60 years. The distribution of age in the non-music group was as follows: 4.4% (2 respondents), <20 years; 31.1% (14 respondents), 21–40 years; 22.2% (10 respondents), 41–60 years; and 42.2% (19 respondents), >60 years 90 respondents successfully underwent their lower limb orthopedic surgery under subarachnoid anesthesia with an estimated operation time of one-and-a-half-hours or less without sedatives and/or opioids.
Visual analog scale (VAS) scores in the music groups and no music groups.
p values based on independent t-test.
SD, standard deviation.
VAS, Visual Analog Score.
HADS scores in the music and no music groups.
HADS scores: 0–7, normal; 8–10, borderline; and >11, need for music therapy.
SD, standard deviation; HADS, hospital anxiety and depression Scale.
STAI-S scores of the music groups and no music groups.
Scores of 20–39 indicate low anxiety level, 40–59 indicate mild anxiety level, 60–79 indicate high anxiety level, and >80 indicate panic status.
STAI-S: Spielberger State-Trait Anxiety Inventory; SD: standard deviation.
Results of correlation analysis on cortisol level, age, and sex.
p < .01.

Scatter plot of association between cortisol and age.
Significant differences in mean scores for systolic blood pressure (SBP_with music) between the no music and music groups based on time (p < .001).
SBP, systolic blood pressure.
Significant difference in mean of systolic blood pressure within the no music groups and music groups based on time (p < 0.001). As shown by the post hoc test, only music group showed significant difference in mean of systolic blood pressure based on time.

Chart showing systolic blood pressure (SBP) for music versus non-music groups.
Significant differences in mean diastolic blood pressure (DBP_off music) between the no music and music groups based on time (p < .001).
Significant difference in mean of diastolic blood pressure within the no music and music groups based on time (p < .001). The post hoc test showed that there is a significant difference in mean of diastolic blood pressure between the music group and no music group based on time. This result indicated that music therapy can make the patients calmer and stabilize their diastolic blood pressure better than the absence of music therapy.

Chart showing diastolic blood pressure (DBP) for music versus non-music groups.
Significant differences in mean heart rate between the music and no music groups based on time (p < .001).

Chart showing heart rate (HR) for music versus non-music groups.
Discussion
The purpose of this study was to evaluate the effectiveness of music in patients undergoing total knee replacement surgery under subarachnoid anesthesia. Anxiety can cause physiological changes, such as increased BP and HR. Hence, instead of measuring anxiety in short intervals, we also monitored the changes in SBP, DBP and HR. We monitored the patients’ SBP, DBP, and HR over three sessions. In the 1st session, there were significant increases in mean SBP, DBP, and HR in both the music and non-music groups. However, the magnitudes of increase for these measures were much higher in the non-music group, indicating that music helped stabilize the patients’ anxiety.
A previous randomized controlled trial reported that patients who listened to music for approximately 30 min showed a reduction in HR, DBP, and SBP. However, a limited number of systematic reviews and meta-analyses have focused on its efficacy in orthopedic patients; therefore, this randomized controlled trial and systematic review provides essential findings on the effects of music therapy on pain after orthopedic surgery. 7
Listening to music via the use of headphones as a form of intervention helps to reduce the anxiety of patients undergoing surgery under regional anesthesia and is highly recommended because this intervention is simple, low-cost, not time consuming, and safe and could act as either a complement or alternative to pharmacological sedation. This intervention made patients feel calm and relaxed. Practitioners (anesthetists or nurses) administering this technique are also more likely to establish a good rapport with the patient during the operation. Patients appreciate the time and effort that is spent helping them deal with stressful procedures. Each phase of anesthesia could proceed more smoothly if the overall anxiety level of the patient is decreased.
The patient’s anxiety is mostly due to pain and is a common problem associated with postoperative orthopedic patients. One study provided 38 postoperative orthopedic patients with pocket-size MP3 players with prerecorded music tracks, and found that music intervention reduced the patients’ level of pain score significantly from 5.40 to 2.98, and a “slight” relationship was noted between listening time and pain relief. 8
In our study, the comparison of VAS scores between patients while they listened to music and after they no longer listened to music was investigated. The lowest pain score was recorded during the period of listening to music, whereas the pain scores increased after stopping the music. Among the patients who received regional anesthesia, the DBP was lower in the music group than in the non-music group. There was also a significant difference in the music group’s DBP when the patients were listening to music.
This study provides further evidence for the use of music therapy as an alternative, non-pharmacological treatment for reducing anxiety in patients undergoing lower limb orthopedic surgery under subarachnoid anesthesia cases in the operating room. Our significant results indicated that music can assists in reducing a patient’s anxiety during the surgery. Therefore, a collaboration with medical device manufacturers to improve the existing machines by adding a music module inside the monitoring system with a complete headphone set to deliver the music to the patient.
Further, anesthetists should be informed regarding the use of music therapy to increase their awareness to select a non-pharmacology intervention at the first place before direct pharmacological intervention (medication). This action can lessen the risk of medication side effects during operation or postoperative sessions. Music should be offered to patients receiving subarachnoid anesthesia as a non-invasive intervention to reduce anxiety. Allowing the patient to choose his or her musical preference will help dispel the bad thoughts that could lead to increased anxiety.
Limitation
A limitation of this study is the fact that the surgeries needed to be completed in an estimated time of approximately 1.5 h to allow each of the three sessions to be 30 min. Therefore, if the surgery needed more or less time than this estimated time, the case was excluded from the study.
Conclusions
This study indicates the clinical applicability of implementing music therapy in operating theaters as an alternative, non-pharmacological intervention, to reduce anxiety in patients receiving regional anesthesia in operating theaters. This research should be extended to large-scale studies and other disciplines.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the K.inbasegaran 2017 Award (Malaysia Society of Anesthesiologists)
