The Effect of Music Therapy on Postoperative Pain Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: a Randomized Controlled Trial
Phase: NA
Conditions: Music Therapy, Perioperative Care, Postoperative Pain, Anxiety, Total Knee Arthroplasty, Vital Signs, Spinal Anesthesia
Sponsor: Abant Izzet Baysal University

 
THE EFFECT OF MUSIC THERAPY ON POSTOPERATIVE PAIN, ANXIETY AND 
VITAL SIGNS IN PATIENTS UNDERGOING SPINAL ANAESTHESIA: A 
RANDOMIZED CONTROLLED TRIAL 
 
 
 
 
 
 
Effect of Music in Intraoperative Period 
 
 
 
 
 
 
 
 
 
 
 
 
20.05.2017 
 

Introduction 
The surgical procedure is an important source of fear and anxiety for patients, in addition 
to the physical trauma. For this reason, the patients may be nervous, restless and anxious. Even 
though, spinal anesthesia is more advantageous compared to  general anesthesia, the status of 
the patients' being awake and hearing all the voices and the conversations of the staff in the 
operation room may cause them to be afraid and uneasy about the intraoperative noise. There 
are studies reporting that post-operative anxiety levels are lower in patients who listen to music 
during spinal surgeries (Koc et al., 2009; Sener, Koylu, Ustun, Kocamanoglu, & Ozkan, 2010). 
Music therapy applications were first used in hospitals, mostly with anesthesia and 
analgesia. The researchers developed theories about the neurological effects of music therapy 
in the twentieth century and experimentally investigated the physiological effects of music 
(Uyar & Korhan, 2011).  
Music therapy affects the neuroendocrine and the autonomic nervous system, resulting 
in physiological and psychological changes. Music therapy, when it is listened to at low 
volumes and low tempos, has the ability to regulate disturbing emotions and reduce nervous 
transitions. As a result, it positively affects the emotional and limbic system, which is the center 
for excitement. Music therapy also increases endorphin release by activating the 
parasympathetic nervous system and stimulating the pituitary gland. Endorphin is a pain 
reliever and has a positive effect on perception (Bansal, Kharrod, Sanwatsarkar, Patel, & Kamat 
H, 2010).  
The benefits of music therapy include regulation of blood pressure, reduction of pulse 
rate (Liu & Petrini, 2015), controlling number of breaths and elevation of oxygen saturation. 
Thus, music is used as an assisting method for patient care (Allen et al., 2001; Bae, Lim, Hur, 
& Lee, 2014). Studies of Bae et al. (Bae et al., 2014), Komurcu et al. (Komurcu et al., 2015), 

and Sarkar et al. (Sarkar et al., 2015) have demonstrated that when listening to music patients 
shift away their attention from the noise in the environment and overheard conversation of the 
surgical team was also avoided or reduced. As a result, the patient's anxiety was reduced. The 
anxiety experienced during the preoperative period and during the operation also causes 
problems in the postoperative period. A study by Chou and Lin reported that people, who 
listened to music, were relaxed and felt more powerful (Chou & Lin, 2006). The most important 
of these anxiety related complications are postoperative pain, weakening of the immune system, 
and the prolonged duration of recovery and the length of stay in the hospital. For this reason, 
controlling and/or eliminating anxiety is a consideration for the post-operative healing process 
[11,17]. 
In the literature, there are studies supporting the views that the music played during 
operation reduces the patient’s anxiety and the result is a reduced use of  anesthetics and 
analgesics. However, it has been determined that there are not enough randomized controlled 
trials to generate strong evidence on the subject. 
The aim of this study was to investigate the effects of intraoperative music played during 
spinal anesthesia operation on patients’ intraoperative vital signs, postoperative pain, and 
anxiety level.  
Hypotheses of the Study  
H1A: In spinal anesthesia, the music played during the operation has an effect on the 
intraoperative vital signs of the patients. 
H1B: In spinal anesthesia, the music played during the operation has an effect on the 
postoperative pain of the patients. 
H1C: In spinal anesthesia, the music played during the operation has an effect on the 
postoperative anxiety level of the patients. 

Methods 
The type of study 
This study is a randomized controlled clinical trial. The aim of this study was to 
investigate the effects of intraoperative music on the patients' vital signs and postoperative pain 
as well as anxiety levels following an orthopedic surgery with spinal anesthesia (Figure 1).  
 
Figure 1: Flowcart of work with consort diagram 
Time and place of the study 
The study was conducted between June 2016 and June 2017 at a university hospital. 

Study design and samples 
The universe of the study consisted of patients, who underwent a planned surgery, took 
spinal anesthesia and knee prosthesis operation in the Orthopedics and Traumatology Clinic at 
a university hospital. 
In the study, 30 patients were assigned to the music group, 30 patients were assigned to 
the group that received sedation and 30 patients were assigned to a group that was not sedated, 
all occurred in a randomized controlled way. 
Patient selection criteria of the present study were as follows:  the patients that had an 
orthopedic operation, took spinal anesthesia, gave consent after being informed, were above 18 
years of age, can speak and read Turkish fluently, did not have vision and hearing problems, 
have a Body Mass Index (BMI) <40, did not have psychiatric disease history and psychiatric 
drug use, did not have diseases that could be evaluated as severe (such as heart, kidney, liver 
failure), and had the ASA (American Society of Anaesthesiologists) I-II-III statuses. 
 
Data collection 
The data collection form was prepared by the researchers. First part of the form 
contained certain demographic information of the patients. Vital signs and the numerical pain 
scale that evaluated the postoperative pain were present in the second part. Preoperative and 
postoperative anxiety levels were measured in the third part of the form through State and Trait 
Anxiety Scales. 
Numerical Pain Scale: It is used by the patient himself/herself to assess and measure 
severity of the pain. The scale begins with the absence of pain (0) and ends at the level of 
unbearable pain (Eti Aslan, 2002; Komurcu et al., 2015). 
State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to 
determine the level of the individual anxiety state. It has 40 items in two constructs of state and 

trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale 
construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 
(almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 
(the highest level of anxiety). The STAI state construct had satisfactory internal consistency 
(α=.90), test-retest reliability (r =.74), and concurrent validity of the STAI state construct 
(Daniel T. L. Shek, 1993).  
Data collection method 
The data were collected by the researcher on the weekdays through the face-to-face 
interview technique. The majority of patients, who underwent spinal anesthesia within the scope 
of the study, were operated on by the same team. Patients were divided into three groups by 
randomization with a computer program. A permuted block randomization scheme was used 
with random block sizes to prevent researcher from guessing the next patient group. The sample 
size calculation was based on the difference by the heart rate in vital signs. To detect a clinically 
significant difference between groups with 85% power and at the 5% significance level, and a 
difference in heart rate between groups of 10 (standard deviation (SD)±10), 26 patients were 
needed in each group. To be able to detect differences in some of the secondary outcomes and 
to compensate for dropouts, we planned to randomize 30 patients per group. The patients were 
randomly divided into groups with a computer program by the researcher and interventions 
were applied. The  allocation  sequence  was  kept  by researcher  until interventions start. The  
trial  was  closed when ⩾30 patients in each group were reached. 
The music were chosen by a researcher under guidance of an expert and grouped as 
relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients 
following the application of spinal anesthesia in the music group. Sedation (Dormicum) was 
performed to the sedated group after spinal anesthesia based on the height and weight data and 
the doctor's decision. The patients in the non-sedated group were followed without any 

procedure (sedation and music). Intraoperative and postoperative vital signs of patients were 
followed and recorded in all three groups. The pain was assessed at the end of the operation, 
which was started with the transfer of the patient to the service and followed by the second 
evaluation at 8 hours postoperative period. STAI was applied to all three groups in preoperative 
and postoperative periods. 
There are no side effects that may arise from the application of music in the intervention 
group. When patients did not want to continue listening to music, the application was terminated 
and the patient was excluded from the study. Sedation was applied to the sedated group based 
on the height and weight data and the doctor’s decision. The patients in the non-sedated group 
was followed up throughout the operation. they felt pain or were intervened immediately in a 
different complication. 
 
The analysis of the data 
The data obtained were coded in a statistical program. The data were expressed as the 
percent, mean, and standard deviation. For the statistical evaluation, one-way ANOVA 
analysis, Kruskal-Wallis, Wilcoxon signed rank test and MANOVA (Multivariate Analysis of 
Variance) tests were used. Following the determination of the overall differences of variables, 
Tukey and Scheffe’s test were performed for homogenous variables. Likewise, Games Howell 
test were performed for variables displayed non-homogenous distribution.   
Limitations of the Study 
The inability to equalize the ambient sounds of the operating room for the control groups 
constitutes the limitations of the study.  

The Ethical Aspects of the Study 
Ethical approval of the present study was obtained from the local ethical committee of 
the university hospital. Information was given to the patients, who were included in the study, 
and their written consents were obtained.