European Journal of Cardiovascular Medicine

Surgery and anaesthesia are uncomfortable experiences for patients, often causing stress and anxiety that can impede the intended therapeutic outcomes. Increased stress and anxiety may have a deleterious impact on post-operative analgesic use and pain perception. Advancements in anaesthesia extend anesthesiologists’ role beyond the surgery, allowing for an anaesthesia in diverse procedures, and raising patient expectations for comfortable treatment. (1) At least two days before the operation, anxiety affects a majority of patients scheduled for surgery.

In the operating room nervousness, doubt and discouragement steadily gain ground alongside anxiety. There are some common physiological reactions to stress and anxiety before surgery which can be evaluated by the VAS-A Scale. This scale is a quantitative self-assessment tool for detecting anxiety. It indicates anxiety level using a number between zero (no anxiety) and 10 (highest anxiety) levels. (2)

Sedation is intended to help patients who are experiencing anxiety and pain to reach a state of tranquility and safety where they may smoothly undergo anaesthesia and surgical operations. (3) However, this is complicated to attain because of the fluctuating sedation level, the expectations of patients, alterations in post-operative situations and various pharmacokinetic and pharmacodynamic characteristics of the applied medications.

Prescribing drugs for perioperative pain and anxiety, as well as complimentary treatments involving hypnosis, acupuncture and music therapy have begun to gain prominence. (4) One of the non-invasive techniques appreciated by patients helping to reduce anxiety and pulse rate is listening to music, which is an ancient form of expression that existed even before language. Research conducted by Khan SH et al suggested that music functions as an anti-inflammatory agent thus lowering the patient’s anxiety and cortisol levels along with seductive effects. (5)

Although there has been increasing interest in music therapy research, the available studies are limited in both quantity and quality, with inconsistent findings being reported. (6) Therefore, the study was conducted to study the effect of music intervention on serum cortisol levels, post-operative pain and anxiety scores among individuals undergoing cholecystectomy.

After obtaining institutional ethics committee approval (SGRD/IEC/2022-163 dated 13.12.2022) and the patient’s informed consent, this prospective semi-experimental randomised single-blind controlled study was conducted to investigate the effect of music (the independent variable) on cortisol levels, VAS-A scores and VAS pain scores (the dependent variables). The study was conducted in 100 patients of either sex in the age group between 18 to 60, with ASA classification I and II, undergoing Laparoscopic Cholecystectomy from January 2023 to December 2023.

 The sample size was calculated using G Power 3.1.9.2 software. The sample size was calculated using previous study by Halder A et al.(2022)  [17] and found to be 68 with 0.95 power and alpha error 0.05. The effect size was calculated to be0.862

The study participants were randomly assigned to three groups using computer-generated random numbers, which were sealed in an envelope. The slip was drawn by a consultant on duty who was not involved in the study, and the assessor was blinded to the intervention. Group A comprised 30 participants who were made to listen to music of their choice.  Group B comprised 30 participants who were made to listen to Binaural tone music and Group C comprised 40 participants with no intervention. Group A and B were provided with headphones of Sennheiser HD 600 with noise cancellation features. In group A patients, music of their choice (Hindustani classical religious, jazz) was started 30 minutes prior to surgery and kept at 69 decibels. In group B patients received binaural tone music with frequency 3.5 Hz. Groups A and B were made to listen to the preassigned music for 30 minutes before surgery and the music was maintained throughout until the end of surgery.

All the study participants received alprazolam 0.25 mg orally at night before surgery. The next day they were shifted to the anaesthesia room one hour before the scheduled time of surgery. A routine monitoring process was conducted in all three groups, and then

The first VAS-A score was assessed before music intervention, the second half an hour after music intervention before surgery and the third assessment was done 30 minutes after surgery.

4ml venous blood was collected in red top vacutainer under aseptic conditions to determine the levels of cortisol at Vitros 5600 by chemiluminescence technology, the first sample was collected half an hour after music intervention before surgery and the second sample was taken 30 minutes after surgery.

VAS pain score was assessed three times after surgery at half-hour intervals, at 30,60,90 minutes after surgery.

Exclusion criteria were any known case of hepatic, renal, cardiac, or respiratory diseases, cognitive and hearing disorders, and chronic treatment with analgesics.

The data were analysed using SPSS Statistics software.  Data was represented in mean ± standard deviation for continuous data and as percentage for categorical data. Categorical variables were statistically analyzed using the Chi-square test, while numerical variables were analyzed with ANOVA.  Student paired t-test was also applied for comparison of serum cortisol levels. The significance level (p value) was established at 0.05. p value <0.05 is considered as statistically significant and p <0.001 as statistically highly significant.

The demographic characteristics of the study participants were analysed and there were no statistically significant differences in the mean values of all the characteristics. (Table 1)

As shown in Table 2 on comparing mean VAS-A scores among the three groups, the difference at the baseline was statistically not significant (p-value 0.77) but when the three groups were compared after the respective interventions, the scores before surgery were significantly lower in group A than in groups B and C (p-value 0.037) additionally, scores of group B were significantly lower than group C. Similar findings were seen when the three groups were compared after surgery (p-value 0.02).

As shown in Table 3, On comparison of mean VAS pain scores among the three groups, a statistically significant difference was seen in VAS pain score at 30, 60 and 90 minutes (p- value 0.0001, p-value 0.003, p-value 0.001 respectively). This denotes that intervention with music of choice lowers pain intensity more than intervention with binaural music when compared with no intervention group.

As depicted in Table 4 on the comparison of cortisol levels before and after surgery in all three groups difference was found to be statistically significant before surgery (p-value 0.03) and statistically highly significant after surgery (p-value 0.000) The values being lower in group A as compared to groups B and C further comparison between groups B and C showed more cortisol level in the C group as compared to group B.

Table 1: Demographic Characteristics of Study Participants

* The Chi-square test

               p<0.05 statistically significant

               p<0.001 statistically highly significant

                              TABLE 2: Comparison of mean VAS-A among the study group

              * One way ANOVA

                p<0.05 statistically significant

p<0.001 statistically highly significant

Figure1 represents the comparison of mean VAS-A among the study group

TABLE 3: Comparison of mean VAS pain score among the three groups

             * One way ANOVA

              p<0.05 statistically significant

               p<0.001 statistically highly significant

Figure 2 represents the comparison of mean VAS pain score among the three groups

Table 4:  Comparison of cortisol level Before and After Surgery in three groups

                * One way ANOVA

                p<0.05 statistically significant

                 p<0.001 statistically highly significant

Figure 3 represents a comparison of cortisol levels Before and After Surgery in three groups

Most approaches to mitigating issues during and after surgery have traditionally relied on medical interventions. In this study, we aimed to explore the impact of music as an inexpensive, non-medical intervention in reducing these issues. Numerous studies have examined the role of music as a complementary therapy, often emphasizing its effectiveness in lowering the problems and costs associated with medical treatments in the groups studied. (7,8) This study was conducted to study the effect of music intervention on serum cortisol levels, post-operative stress and anxiety scores among individuals undergoing cholecystectomy.

 Preoperative and postoperative comparison of cortisol levels in three groups showed a significant difference before surgery (p-value 0.03) and a highly significant difference after surgery (p-value 0.0000) with higher mean values in group C as compared to groups B and A. (table 4) This suggests that music might help prevent anxiety and consequently the rise in blood cortisol levels. This was in concordance with the study done by Stefan Koelsch et al. who concluded that listening to music lowers cortisol levels showing stress-reducing effects during surgery.  (9)

Another study by Linda L. Chlan (2007) found that music did not significantly affect patients' cortisol levels. The authors of that study suggested that this might be due to the time interval between the intervention and the measurement of cortisol levels. (10)

In this study, postoperative pain scores using the VAS score were evaluated across all three groups at various time intervals. Patients in the self-selected music group had significantly lower pain scores, followed by the binaural tone music group and then the control group. This finding contrasts with Patiyal et al., who reported that music did not affect postoperative opioid consumption. (11) However, our results align with those of Binns-Turner et al., who demonstrated significantly lower VAS in the intervention group as compared to the control group, (12) Similarly, Kwon et al. also observed lower pain scores in patients who listened to music perioperatively. (13)

When considering the VAS-A score assessment across all three groups before and after surgery patients in the self-selected music group had significantly reduced VASA-A scores, followed by the binaural tone music group and then the control group. This finding was in concordance with the study conducted by Markandey Parsad et al (14)

Study concluded by Erhan Gokcek, and Ayhan Kaydu concluded Music therapy, a nonpharmacologic intervention, effectively enhances awakening, stabilizes hemodynamic parameters, and reduces the need for analgesics in the postoperative period without any side effects. (15) Also, it helps decrease anxiety and intraoperative awareness episodes in surgical patients.

The widely accepted theory for the pain, anxiety, and stress-reducing effects of music suggests that music serves as a distraction, redirecting the patient’s attention from negative stimuli to something pleasant and uplifting. Music engages the patient's mind with something familiar and comforting, allowing them to retreat into their "own world."(16) Moreover, patients can concentrate on the music to help them relax. Also, Music therapy works by providing positive stimuli to the central nervous system, which competes with pain signals, thereby reducing pain perception. (17) Music also lowers anxiety by activating auditory pathways and the limbic system, which interact with the hypothalamus, reticular activating system, and hippocampus to induce relaxation.

Music therapy especially listening to music of choice is a safe and effective non-invasive non-pharmacological intervention with several benefits for surgical patients. It reduces the need for pain medication during the postoperative period without causing any side effects. It also hinders the increase of blood cortisol levels. Additionally, music therapy helps lower anxiety enhancing the overall surgical experience for patients.

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