Quality of life is a multidimensional concept, encompassing several dimensions, such as physical, social and emotional, which appraise the personal well-being of patients. It is a very useful variable to evaluate the efficiency of treatments and to predict the possible negative effects of the disease,1 for this reason it has become a fundamental perception for the integral care of the patient.2

Most studies on health-related quality of life (HRQoL) in patients with chronic kidney disease (CKD) on hemodialysis (HD) show that these patients have a lower HRQoL than the reference values of the general population in all subscales of the SF-36 questionary.3–8

It is important to note the review of studies on HRQOL in advanced CKD in Spain, carried out by Rebollo-Rubio et al.;9 after the analysis of 53 articles published between 1995 and May 2014, it was concluded that, in most of the studies analyzed, the HRQOL was significantly affected in patients treated with dialysis.

There are several instruments to measure HRQOL, among them the Kidney Disease Quality of Life (KDQOL-SF) health questionnaire.10 This is a mixed scale that evaluates components for the general population, and at the same time it has a specific level for CKD. The KDQOL-SF scale is one of those with most publications relative to its validation and adaptation to different languages worldwide and its psychometric characteristics are reliable, Cronbach's alpha is >0.7, and its utility is adequate because it is easy to apply and not very complex.11

Many authors have investigated the impact of live music intervention on different pathologies. Through music therapy, it has been shown that music has a beneficial effect and has managed to reduce levels of stress, pain, anxiety, applying it as an adjuvant to treatments.12–18 For example, in the study by Bradt et al.19 they conducted a systematic review of the impact of music therapy (a personalized musical treatment offered by trained music therapists) and music medicine (listening to music recorded by a doctor or nurse), and the physical and psychological effects on cancer patients. They analyzed a total of 52 clinical trials with 3,731 patients, divided into 23 trials of music therapy and 29 as music medicine. They concluded that musical interventions can have beneficial effects on anxiety, pain, fatigue and quality of life in these patients. In addition, they observed that music may have a discrete effect on heart rate, respiratory rate, and blood pressure. However, most of the trials analyzed had a significant bias, so the results should be interpreted with caution.

In addition, Uchiyama et al.20 investigated the effect of music on the regulation of the immune response in mice undergoing heart transplantation. They concluded that mice exposed to opera-type music (La Traviata), classical music (Mozart), or Enya music had a greater regulatory response (decreased IL-2 and interferon-γ) than those that were not exposed.

However, we have not found any study that has examined in depth the influence that music can have on the quality of life of renal patients; therefore, the aim of the study was to test the effect of listening to live classical music in the patient's own living room while receiving HD treatment on the HRQOL of patients with CKD.

This is a prospective randomized intervention study, with cluster randomization for logistic reasons. It was carried out in a hospital HD unit with 3 shifts per day (morning, afternoon and evening). For reasons of time incompatibility of the musicians, the night shift was excluded from the study and the study was carried out in 4 dialysis shifts with a total of 120 patients:

• A

  Monday, Wednesday and Friday mornings.

• B

  Monday, Wednesday and Friday afternoons.

• C

  Tuesday, Thursday and Saturday mornings.

• D

  Tuesday, Thursday and Saturday afternoons.

Patients were informed both orally and in writing of the details of the study, its risks, benefits, and the inclusion and exclusion criteria for participation in the research project.

Inclusion criteria: Patients over 18 years of age, give informed consent, have been in chronic HD program for more than 3 months.

Exclusion criteria: inability to hear the music, inability to answer the surveys, failure to give informed consent to participate, under 18 years of age, hospital admissions for more than 4 weeks or in the last 2 weeks of the intervention.

All those who met the inclusion criteria and decided to voluntarily participate in the study received and signed the informed consent to allow access to their medical data.

A draw was made through stratified sampling to form 2 groups, an intervention group (IG) made of shifts A and D, which had the music component, and a control group (CG) made of shifts B and C according to the results of the draw.

During the one-month period, live musical performances were held in the HD rooms in 2 of the 3 weekly sessions. The musical sessions lasted about 30/40 min. Patients completed the KDQOL-SF questionnaire, during the 2.a and 3.a hour dialysis session, at baseline and in the last week of the intervention.

The descriptive variables recorded were:

• none-

  Cause of kidney disease.

• none-

  Months on HD treatment.

• none-

  Sex.

• none-

  Age.

• none-

  Vascular access: arteriovenous fistula or central venous catheter.

• none-

  Kt/V Daugirdas 2.a generation based on serum urea specifications before and after HD.

• none-

  Consumption of psychotropic and/or analgesic medication.

• none-

  Serum hemoglobin (g/dL).

• none-

  Serum albumin (g/dl).

• none-

  Mean blood pressure (mmHg) on the day of the survey.

The outcome variable was the score obtained in the KDQOL-SF quality of life questionnaire.

Regarding the sample size, it was calculated that, accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, a total of 36 patients were needed in each of the groups to detect a difference equal to or greater than 2 points. The common standard deviation was assumed to be 3 and a correlation coefficient between the initial and final measurements of 0.6. A loss-to-follow-up rate of 20% was estimated. Therefore, more than 36 patients per group were recruited.

The present study respects the fundamental principles established in the Declaration of Helsinki, in the Council of Europe Convention on Human Rights and Biomedicine, in the UNESCO Universal Declaration on the Human Genome and Human Rights, and it meets the requirements established in the Spanish legislation according to the Data Protection Act 3/2018 of December 5, in the field of biomedical research, protection of personal data and bioethics.

Intervention: development of the musical sessions

For the development of the musical sessions, 30 professional musicians collaborated, all of them teachers of higher conservatories, teachers of professional music conservatories and musicians of professional orchestras, which allowed us to form many and varied chamber music groups and play a large repertoire of musical pieces of different styles, from Bach, Beethoven or Mozart, to music of groups such as Queen or the Celtas Cortos. The number of musicians per group was limited to a maximum of 4 per session, since the musical sessions took place between beds and health personnel, avoiding interfering with patient care.

Four weekly auditions were performed during the month; the 90 IG patients listened to all the chamber ensembles, thus avoiding any kind of bias. The HD room is distributed in 3 subrooms, the musicians were placed in different locations to facilitate visual contact with the patient and not only auditory contact. Fig. 1 shows images of the performances.

Fig. 1.

Images of the performances.

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A total of 120 patients were selected for the study, 92 agreed to participate and the sample was finally reduced to 90; one patient died and was eliminated and the other was to transfered to another hospital. The clinical and demographic characteristics of the patients included in this study are specified in Table 1.

The results of the statistical analysis show that the difference between the time pre- and post- in IG as compared to the CG increased the mean score significantly in 18 of the 21 test scales (Table 2). The results indicate that the control and intervention groups have evolved differently between the 2 time points, and that this difference in evolution is significant in 18 scales of the test. The Pain, Social Function, Emotional Role and Physical Role scales are noteworthy, since these variables in the IG underwent an increase that differed by more than 40 points with respect to the difference in these same variables in the CG between the 2 time points (Fig. 2).

Fig. 2.

Distribution of the Pain, Social Function, Emotional Role and Physical Role scales of the KDQOL-SF questionnaire for the control group (CG) and the intervention group (IG) at the 2 time points analyzed (pre- and post-intervention). The horizontal lines indicate the mean value of the scale for CG and IG respectively at each time point. In relation to the statistical data obtained, the difference in the temporal evolution of the two groups is very pronounced in the Pain, Social Function and Emotional Role scales, since the values of these scales increase considerably in GI, but decrease in CG. On the other hand, the Physical Role scale increases in both groups, but the increase in IG is much greater than in the CG group.

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As for, the analysis of covariates, in the linear mixed regression models implemented only the effects of sex and albumin were significant (p < 0.05) for several of the test dimensions. The remaining covariates studied were not significant (p > 0.05) for any of the dimensions studied.

Specifically, the effect of sex (male over female) was significant (p < 0.05) for the dimensions Symptoms/problems (9.12), Effects renal disease (8.75), Sexual function (20.21), Physical function (12.21), Physical role (9.12), Pain (18.63), Social function (12.07) and S.E. changes (11.60). In all these variables, the effect was positive, so it can be deduced that the score of the test variables tends to be higher in men.

Additionally, the effect of albumin turned out to be significant (p <.  0.05) for the dimensions Symptoms/problems (8.86), Effects renal disease (11.74), Burden renal disease (13.67), Vitality (18.87), Sexual function (21.16), Physical function (17.51), Physical role (16.20), Pain (19.25), Emotional well-being (17.87), Social function (17.31) and General health (13.89). In all these variables the effect was positive, so it can be deduced that the higher the albumin value the greater the response to the dimensions of the test.

The application of music in medicine has been present since ancient times, and has evolved according to the customs and beliefs of each era; all this has been weaving the background of what we know today as music therapy.

According to Maranto,23 this concept in the field of medicine is defined as the use of music therapy strategies to help in the treatment of diseases and in the restoration of people's health.

Previous studies have revealed the benefits that music has on the disease in different pathologies, such as Oncology, ICU, Surgery, even in patients with kidney disease on HD treatment.24–27 In 2006, da Silva28 measured the therapeutic effect of music in patients with CKD on HD treatment, through a qualitative study by analyzing patients' narratives. He concluded that the presence of music in HD sessions had a satisfactory therapeutic effect. The therapy was positive in terms of alteration in the perception of time, providing feelings of well-being, joy, happiness, relaxation, entertainment, change in routine, absence of symptoms or positive thoughts. Other authors such as Bechert Carminha et al.29 analyzed the influence of the quaternary rhythm of music on emotions, on the perception of time and on the appearance of hypertension and pain in the patient during the dialysis session. The results showed that more than 80% of the patients reported that they felt better and also that time passed faster. In the clinical context, the study indicates that the musical intervention was beneficial, but was not determinant in the reduction of pain and blood pressure.

As we can see, most of these studies evaluate the effect of music on anxiety, stress and pain, however, the effect of music on the quality of life of the HD patient has not been evaluated. In addition, the application of music in most cases has not been carried out in a direct way but in a passive way through recorded music.

One of the innovations of our study is the fact that classical music was played live in the hospital itself, while the patients were receiving HD treatment. This direct contact, both visual and acoustic, could enhance the effect produced by music and should be the subject of future studies.

It should not be forgotten that patients with CKD have an HRQOL well below the reference values of the general population. Patients with CKD should be valued as biopsychosocial beings, since the emotional aspect is a determining factor for the success of treatment and for the improvement of quality of life.29 This self-perceived quality of life is what we have tried to improve in our study through musical exposure, the subjective well-being of patients, i.e. what they think and how they feel about their lives, after the application of music during HD. This well-conducted musical application has proved to be a relevant therapeutic resource and has favorably influenced the patient, since we have obtained a satisfactory and highly relevant result in 18 of the 21 scales. As limitations of the study we can consider that there was scarce representation of the working population, so the work situation scale is not evaluable due to the scarce representation of this population, only 20/90 were of working age and, of these, only 6 were working (6.6%) and of the population with a sexual life, only 70/90 (22.2%) had an active sexual life, the rest did not, due to age or lack of a partner. This may have influenced the lack of positive results on these scales found in our study. The social support scale was not modified by the music either, perhaps because the intervention was short term and changes in this type of parameters could be expected in a long term intervention, if they were to occur.

In short, we can deduce that the measurement of HRQOL should be present in the routine practice of renal units, since it provides us with very valuable and important information, and allows us to act on the most affected parameters. In addition, the results indicates that music should be part of the renal patient's treatment, since we have shown that it is an aid to improve their quality of life, and it is not harmful in any way, thus achieving the best possible state of well-being for these patients.

In conclusion, a live musical intervention during HD treatment improves self-perceived HRQoL in patients with CKD.

This research has not received specific support from public sector agencies, commercial sector or non-profit entities.

The authors declare that they have no conflicts of interest.