Effect of Western-based and five-element music therapy on patients undergoing maintenance hemodialysis: study protocol for a randomized controlled trial

doi:10.21203/rs.3.rs-4900124/v1

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Study protocol

Effect of Western-based and five-element music therapy on patients undergoing maintenance hemodialysis: study protocol for a randomized controlled trial

https://doi.org/10.21203/rs.3.rs-4900124/v1

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Background

Music therapy has emerged as a significant complementary approach to psychotherapy. However, due to the intricate interplay between music and culture, the comparative effectiveness of five-element music therapy and Western music therapy for Chinese patients undergoing maintenance hemodialysis warrants further investigation.

Methods

In this prospective randomized controlled trial, 87 patients on maintenance hemodialysis will be recruited and randomly assigned in a 1:1:1 ratio to the five-element music group, Western music group, and control group. Participants in the Five-element music group and Western music group will receive eight weeks of five-element music therapy and Western music therapy, respectively, for 60 min per session, three times per week. All outcome indicators will be measured at baseline, week 4 of the intervention, week 8 of the intervention, and after a follow-up period of 4 weeks at the end of the intervention. The primary outcome indicator will be the Hospital Anxiety and Depression Scale (HADS). Secondary outcome indicators will include the Pittsburgh Sleep Quality Index (PSQI), the Dialysis Symptom Index (DSI) and the Positive and Negative Emotions Schedule (PANAS).

Discussion

The trial will evaluate the effects of Western music and traditional Chinese five-element music on emotion, sleep and symptoms of patients undergoing maintenance hemodialysis. This study is expected to provide a more personalized and effective music therapy program for patients on maintenance hemodialysis which can be added to the treatment of patients on maintenance hemodialysis as a non-invasive complementary and alternative therapy to help improve the quality of life of patients on maintenance hemodialysis.

Trial registration:

The trial was registered with the Chinese Clinical Trial Registry on 14 June 2024 under registration number ChiCTR2400085665.

Five-element music

Western music

Music therapy

Maintenance hemodialysis

Randomized controlled trial

End-stage renal disease (ESRD) is the final stage of chronic kidney disease progression. Due to the limited availability of kidneys and economic reasons, 90% of patients with ESRD choose maintenance hemodialysis for treatment[1]. Statistics indicate that the global number of individuals undergoing maintenance hemodialysis approached 3 million in 2017[2]. As of the end of 2022, the China National Renal Data System (CNDRS) reported that the number of patients on maintenance hemodialysis had increased to over 844,000, with a continuing upward trend each year[1]. Maintenance hemodialysis effectively substitutes some of the kidney’s functions by removing metabolic waste and excess bodily fluids. However, due to the high frequency and long duration of dialysis cycles, patients on maintenance hemodialysis often face psychological and sleep issues, resulting in increased negative emotions and decreased positive emotions. Evidence indicates that the prevalence of depression and anxiety in patients on maintenance hemodialysis reaches 55% and 50%, respectively[3], with 64% experiencing varying degrees of sleep disorders[4]. Studies have shown that anxiety and depression reduce patients' adherence to dialysis[5], as well as causing a variety of symptoms such as decreased appetite[6], fatigue[7], reduced sleep quality[8], and other symptoms of distress, which affect patients' quality of life and are even associated with an increase in mortality[9].

In the treatment of depression and anxiety in patients on maintenance hemodialysis, there is a significant gap in care[10], compounded by the potential side effects of current antidepressant medications. Selective serotonin reuptake inhibitors are commonly prescribed, but studies indicate that these medications may cause nausea, vomiting, and even elevate the risk of bleeding[11] and hip fractures[12]. Another antidepressant, sertraline, has a high rate of adverse events, leading to increased discontinuation, and its efficacy in alleviating depressive symptoms does not significantly differ from that of a placebo[13]. Other antidepressants, such as serotonin regulators, tricyclics, and tetracyclics, may cause arrhythmias and orthostatic hypotension[11]. Currently, there is insufficient scientific evidence regarding the efficacy and safety of antidepressants for treating depression and anxiety in patients on hemodialysis[14]. Furthermore, research[15] indicates that the use of hypnotics increases the risk of adverse reactions in patients on hemodialysis. Given these challenges, identifying a safe, non-pharmacological therapy without side effects is essential. Music therapy, a form of complementary and alternative medicine, has been shown to be beneficial for patients with various chronic and advanced diseases, effectively utilizing patients' free time during dialysis sessions[11]. This intervention is widely accepted by patients and has a low dropout rate. Research[16] has demonstrated that music therapy can serve as an effective nursing intervention, improving the quality of life for hemodialysis patients by alleviating anxiety and depression.

Music therapy leverages music to regulate patients' physical and psychological health[17]. Western music therapy and five-element music therapy have become key areas of research, showing promising positive impacts on emotional well-being and physiological function. Western music utilizes a seven-note scale, predominantly categorized into major and minor modes. Major modes typically evoke positive emotional experiences, such as happiness, while minor modes tend to elicit negative emotions like sadness, fear, and anger. Western music therapy utilizes these different modes to stimulate and modulate patients' emotions[18]. Five-element music therapy originates from the ancient Chinese text "The Yellow Emperor's Canon of Internal Medicine"[19], which states, "There are five tones in heaven and five organs in human". The five tones are "Gong, Shang, Jue, Zhi, and Yu", corresponding to the five organs of "spleen, lung, liver, heart and kidney". According to this theory, aligning music's varied tones with the respective organs can enhance organ function and promote the balance of qi and blood, thereby aiding in the restoration of health[20]. Five-element music therapy has extensive applications in Traditional Chinese Medicine (TCM), including treating various diseases and regulating emotions. In recent years, with increased attention to physical and mental health, five-element music therapy has been increasingly integrated into modern medicine as a complementary treatment modality. Although research indicates that five-element music can alleviate depression symptoms, its effect on anxiety is a topic of debate. Jiang et al.[21] reported the effectiveness of five-element music in reducing anxiety in patients with lung cancer. However, Yang et al.[22] suggested that the impact of five-element music might be less significant compared with conventional treatments for patients with cancer. This discrepancy underscores the need for research to clarify the effect of five-element music therapy on anxiety reduction.

Music is a phenomenon that exists in all human cultures. Through its acoustic and physical properties, music elicits emotional responses in listeners[23, 24]. This indicates that the influence of tonal patterns on emotional arousal is culturally universal. However, there are cultural differences in how individuals from different backgrounds perceive and respond to music, particularly in terms of their emotional and physiological reactions[25]. Research[26] indicates that individuals are better able to categorize music from their own culture compared to music from other cultures, supporting the cultural distance hypothesis. Interestingly, a similar pattern emerges when comparing the effects of five-element music and Western music on emotional well-being. The debate over the comparative effectiveness of five-element and Western music remains unresolved, with limited randomized controlled trials comparing their applications. Liao et al.[27] explored the effects of five-element music and Western music on negative emotions such as depression and anxiety among participants from Canada and China. The results showed that only the group exposed to five-element music experienced significant reductions in anxiety and depression scores, especially among Chinese participants. Notably, the investigators targeted individuals who had mild depression symptoms and suboptimal health, and the study group differed from the maintenance hemodialysis group in several ways, including disease characteristics and severity of illness.

Currently, research is insufficient to compare the effects of the two types of music in patients on maintenance hemodialysis. Based on these findings, we designed a randomized controlled trial to investigate the psychological and physiological impacts of these two culturally distinct music therapies and compare them with a control group, providing more diverse and personalized adjunctive treatment options for clinical practice. Because five-element music reflects Chinese culture, we hypothesized that five-element music would offer superior benefits in improving the emotion, sleep quality and symptom burden of patients on maintenance hemodialysis compared with Western music therapy; in addition, we expected both approaches to be more beneficial than the control group. The following is a summary of our study and design.

Study design

This is a prospective, three-arm, randomized controlled trial, comparing the effects of traditional Chinese five-element music therapy and Western music therapy on patients undergoing maintenance hemodialysis. A total of 87 patients on maintenance hemodialysis will be randomly assigned in a 1:1:1 ratio to the five-element music group, the Western music group or control group. The study procedures are shown in the accompanying Fig. 1. The trial was prospectively registered in the China Clinical Trial Registry on June 14, 2024, with the registration number ChiCTR2400085665. The trial will adhere to the Helsinki Declaration and follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Sample size calculation

The sample size estimation was calculated using G*Power 3.1 software (Heinrich Heine University, Düsseldorf, Germany). Based on previous literature, the effect size was set at 0.16[28], with a significance level of 0.05 and power (1-β) of 0.8. The study was designed to include three groups with a total of three repeated measurements. Substituting these values into the software indicated that a total of 69 participants would be needed, with 23 participants in each group. Assuming a 20% attrition rate, the sample size was increased to 29 participants per group, resulting in a total of 87 participants across the three groups.

Protocol Development

The creation of a music therapy program leverages Martha Roger’s Unitary Human Beings Theory[29], which views humans and their environment as interconnected dynamic energy fields. Music, within this system, acts as a transformative element, influencing human energy fields by auditory vibrations. Grounded in Roger’s theory, the interventions in music therapy are individualized. Therapists treat music as a key part of the environmental energy and tailor their choices to align with the patients' specific needs and therapeutic objectives. The goal is to harmonize therapeutic musical elements with patients' energy fields to enhance relaxation, enable emotional expression and encourage developing healthier energy patterns. Therapists must closely observe patients’ reactions, adjusting musical components and the therapeutic setting for effective energetic interactions that aid healing in individuals.

Study population

Eligibility criteria

Patients will be enrolled if they meet all of the following inclusion criteria: ①meet the diagnostic criteria for ESRD; ②have undergone regular hemodialysis for ≥ 3 months; ③age ≥ 18 years old; ④are aware of their condition, are voluntarily participating in the study, and sign the informed consent form; ⑤are able to complete the questionnaire independently or with assistance; ⑥have clear consciousness and no hearing impairment; ⑦score > 7 points on the Hospital Anxiety and Depression Scale (HADS).

Patients meeting any one of the following criteria will be excluded: ①severe complications or conditions too severe to cooperate; ②consciousness disorders or mental illnesses; ③have undergone kidney transplantation, are on peritoneal dialysis, or were uncooperative with the study; ④are currently undergoing other interventional treatments.

Recruitment

Eligible patients on maintenance hemodialysis will be recruited from the hemodialysis room of the Affiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University, China. Initially, two research assistants will assess patients' eligibility based on the inclusion and exclusion criteria. Patients who meet the criteria will then be asked to sign an informed consent form. Upon voluntarily signing the consent form, he or she will be invited to participate in the trial. Recruitment commenced on 20 June 2024 and will continue until 87 participants are enrolled.

Baseline assessment

Recruiters will use a self-designed questionnaire to collect baseline information from all eligible participants. Baseline information includes participants' demographic data and disease treatment details. Demographic data comprise gender, age, ethnicity, educational level and marital status. Disease treatment details include primary disease, duration of dialysis and presence of complications.

Randomization, allocation concealment and blinding

Random group assignment numbers will be generated using SPSS software (IBM, Armonk, NY, USA) by researchers not involved in the intervention or data analysis. Opaque sealed envelopes will be used to conceal the assignment numbers. Eligible patients will then be randomly assigned to one of three groups in a 1:1:1 ratio. Because of the specific nature of the music intervention, it is difficult to blind the subjects in this trial, but outcome assessors and data analysts will be blinded.

Intervention protocol

All three groups of patients will continue to receive routine treatment in the hemodialysis unit carried out as usual, including dialysis treatment, daily care, and health education.

Control group

Patients assigned to the control group will not receive any form of music therapy. To ensure fairness, patients in the control group will be invited to receive the same five-element or Western music intervention as the intervention group at the end of the study.

Five-element music group

Patients assigned to the five-element music therapy group will receive five-element music therapy for 8 weeks, three times per week for 60 min. The intervention sessions will be scheduled according to the hemodialysis timetable and conducted during the patients' hemodialysis sessions. The music library houses the Traditional Chinese Five-element Music published by the Chinese Medical Association Audio-Visual Publishing House (Beijing, China), encompassing five modes: Jue, Zhi, Gong, Shang, and Yu. This library is extensively used for personal psychological and physiological treatment[30].

We constructed a five-element structured intervention program with four steps: (1) A TCM nephrologist with the title of intermediate or above will perform syndrome differentiation of viscera for patients; (2) the music therapist will select the corresponding five-element music tones and tracks for the patient according to the syndrome characteristics of the patient's viscera; (3) a therapist will explain the precautions of music therapy to the patient, instruct the patient how to follow the rhythm of the music to breathe deeply, so as to quickly enter a state of relaxation, and will guide the patient to follow the music in his or her imagination; and (4) after the treatment, the therapist will communicate with the patients about their feelings and experiences, and summarize any problems that arose during the intervention.

Patients participating in the music intervention will use wireless Bluetooth headphones and MP3 players as auxiliary equipment. Participants can adjust the volume according to their personal preferences.

Western music group

Patients in the Western Music Group will receive Western music therapy for 8 weeks, three times per week for 60 min. The Western Music Repertoire, curated by Professor Gao Tian[31], who has a high level of expertise in music therapy, encompasses major genres such as Baroque style, Classical school, Romantic school and National school. It is designed for emotional regulation. Music therapists select genres and musical pieces for patients based on their sociocultural background, psychological condition, musical preferences and the attributes of the music. Other intervention procedures and schedules will be the same as those for the five-element music group.

Outcome measures

Primary outcome measure

The primary outcome will be assessment of the patient's anxiety and depression using the HADS[32]. The HADS was developed by Zigmond and Snaith in 1983, primarily for screening anxiety and depression symptoms in general hospital patients. It consists of 14 items, with 7 items assessing depression and 7 items assessing anxiety. The scores for the anxiety and depression subscales are divided as follows: 0–7 points indicate no symptoms; 8–10 points indicate possible symptoms; and 11–21 points indicate definite symptoms.

Secondary outcome measures

Sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI)[33]. The PSQI is used to assess sleep quality over a 1-month period. It consists of 19 self-rated items and five observer-rated items, with the 19th self-rated item and the fifth observer-rated items not included in the scoring. Here, we will only introduce the 18 self-rated items that are scored. The 18 items are grouped into seven components, each rated on a scale of 0 to 3. The cumulative score of these components constitutes the PSQI total score, which ranges from 0 to 21, with higher scores indicating poorer sleep quality.

Symptom distress will be measured by the Dialysis Symptom Index (DSI)[34]. The DSI is based on the Memorial Symptom Assessment Scale Short Form, which is comprised of 30 items primarily measuring the occurrence and degree of symptoms among hemodialysis patients (over the past week). DSI was adapted by Chinese scholar Yanhua Hao[35], incorporating symptom frequency and severity into four dimensions. Symptoms are assessed for presence ("yes" or "no"), frequency and severity using a Likert scale ranging from 1 (rare or mild) to 4 (almost constant or severe). Distress levels are rated on a 5-point Likert scale, where 1 indicates no distress and 5 indicates severe distress. In addition to the 30 specified symptoms, the scale includes an open-ended question to identify other issues troubling patients.

Positive and negative affect will be assessed using the Positive and Negative Emotions Scale (PANAS)[36]. The PANAS was developed by Watson, Clark et al. in 1988 based on a two-dimensional model of emotions. The scale includes 20 words describing emotions, with ten positive and ten negative words, all scored positively. Statistical analysis will be performed on two factors: positive affect and negative affect, resulting in positive affect scores and negative affect scores. Participants will be asked to rate the intensity of emotions they experience in their current state on a 5-point scale, where 1 indicates "very slightly or not at all," 2 indicates "a little," 3 indicates "moderately," 4 indicates "quite a bit," and 5 indicates "extremely."

Adverse events

All intervention tools that come into contact with study participants will be disinfected before and after use. Researchers will strictly follow hand hygiene protocols using disinfectants before and after each intervention session with participants. During the intervention, participants will be monitored for adverse reactions. Adverse reactions to music therapy will be assessed by asking participants if they feel "more sad or uncomfortable." If any adverse reactions occur, the interveners will promptly record and report them. Appropriate medical assistance and psychological support will be provided according to the patient's wishes.

Table 1 shows the evaluation schedule.

Table 1

Study time-period
	Study period
Phase	Enrollment	Baseline period	Period of treatment		Period of follow-up
Time (weeks)		Week 0	Week 4	Week 8	Week 12
Inclusion/exclusion criteria	√
Informed consent obtained	√
Demographic data		√
Hospital Anxiety and Depression Scale (HADS)		√	√	√	√
Pittsburgh Sleep Quality Index (PSQI)		√	√	√	√
Dialysis Symptom Index (DSI)		√	√	√	√
Positive and Negative Emotions Schedule (PANAS)		√	√	√	√
Adverse event record		√

Statistical analysis

Data will be analyzed using SPSS 26.0 (IBM, Armonk, NY, USA) following the intention-to-treat (ITT) principle; thus, all randomized patients who meet the selection criteria will be included in the analysis. The statistical significance is two-sided with p < 0.05. Analysis of covariance will be used in the presence of meaningful baseline differences. Missing data will be added using the last observation carried forward (LOCF) method.

Quantitative normally distributed variables including means and standard deviations will be presented. Continuous variables adhering to a normal distribution will be analyzed using one-way analysis of variance, whereas the Kruskal-Wallis H test will be used for continuous variables that do not follow a normal distribution. Categorical variables will be assessed using the chi-square test. Generalized estimating equations will be used to detect differences between each pair of groups, between baseline and follow-up data, and group×time interactions.

Data collection and management

Data will be collected independently by an assistant unaware of the recruitment and allocation process. The primary and secondary outcomes will be measured at baseline (the day before the intervention), week 4 of the intervention, week 8 of the intervention, and after the follow-up period at week 4 at the end of the intervention. Participants in the control group will be asked to complete the measurements at the same time points. All questionnaires will be distributed in paper form, collected and then archived by professionals.

This study protocol outlines a randomized controlled trial aimed at evaluating the therapeutic effects of Western music therapy and five-element music therapy on patients undergoing maintenance hemodialysis. The primary focus is to assess the impact of these music therapies on the emotional state, sleep quality and symptom distress of patients on maintenance hemodialysis. Given that hemodialysis is a long-term chronic condition, music therapy, as a non-pharmacological intervention, offers significant advantages due to its ease of implementation and cost-effectiveness. Additionally, patients can receive this intervention during their maintenance hemodialysis sessions without requiring extra time, which markedly enhances patient acceptance of music therapy.

The core mechanism of music therapy lies in the interaction between suitable musical rhythms and abnormal bodily rhythms. Through adjustment and guidance, the body's rhythms gradually align with the musical rhythms, ultimately producing a resonance response, thereby exerting therapeutic effects on the body[37]. This mechanism is applicable not only to Western music but also to Chinese five-element music. However, despite the universal emotional expression and aesthetic value of music, different music systems and their cultural contexts may significantly influence therapeutic outcomes. From the perspective of cultural relativism and cultural pluralism in anthropology, five-element music and Western music therapy each have unique features and differ in their therapeutic methods and theoretical foundations. TCM five-element music therapy incorporates the principles of Chinese traditional medicine[20], based on the five-element theory, and aims to restore internal balance by targeting specific organs. This distinguishes TCM music therapy from music therapies in other cultural contexts.

One of the strengths of this study is the use of a randomized controlled design, providing high-level evidence for the efficacy of the interventions. Both five-element music therapy and Western music therapy utilize well-established music libraries, ensuring standardization and reproducibility of the interventions. Additionally, the differentiation of patients by experienced TCM nephrology doctors adds a layer of specificity to five-element music therapy, potentially enhancing its effectiveness.

This study aims to provide robust evidence for the efficacy of Western music therapy and five-element music therapy in patients on maintenance hemodialysis. We anticipate that this study will offer an economical, effective and non-invasive music therapy option for patients on maintenance hemodialysis. This approach will help patients better cope with the physical and mental challenges posed by their condition. By improving acceptance of the treatment, music therapy can significantly enhance patients' treatment experience and quality of life as an adjunct to hemodialysis treatment. The distinctions between Western music therapy and five-element music therapy also offer insights into personalized medical approaches, allowing clinicians to tailor interventions based on individual patient needs and preferences. Furthermore, this study may provide theoretical and practical foundations for the application of music therapy in the management of chronic diseases in the future.

Trial status

At the time of submission, recruitment for the trial has been completed. The first participant was included on 20 June 2024.

HADS: Hospital Anxiety and Depression Scale

PSQI: Pittsburgh Sleep Quality Index

DSI: Dialysis Symptom Index

PANAS: Positive and Negative Emotions Scale

ESRD: End-stage renal disease

CNDRS: China National Renal Data System

TCM: Traditional Chinese Medicine

CONSORT: Consolidation Standards of Reporting Statemen

ITT: the intention-to-treat

LOCF: last observation carried forward

Availability of data and materials

Data sharing does not apply to this article because no data sets were generated or analyzed during this study.

Acknowledgments

Not applicable.

Funding

No funding.

Author information

Jing-yi Zhang, Wen-min Wu, and Li-ping Zhang contributed equally to this work.

Authors and Affiliations

School of Nursing, Guangzhou Medical University, Guangzhou, Guangdong, China

Jing-yi Zhang, Wen-min Wu & Yun Gao

Hemodialysis Room, The Affiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Li-ping Zhang, Su-jin Zhou & Xuan-ying Ye

Department of Nephrology, The Affiliated Traditional Chinese Medicine Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Hui-ping Zeng

Contributions

ZJY, GY, and ZHP were instrumental in conceiving and designing the study. ZJY, WWM, and ZLP drafted and revised the manuscript. ZSJ and YXY developed the statistical analysis plan. All authors read and approved the final manuscript.

Corresponding authors

Correspondence to Yun Gao or Hui-ping Zeng

Ethics declarations

Ethics approval and consent to participate

Ethics approval was given by the Ethics Committee of Traditional Chinese Medicine Hospital Affiliated to Guangzhou Medical University (2023NY0028). Informed consent will be obtained from any potential participant to the study team.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests

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No competing interests reported.

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Effect of Western-based and five-element music therapy on patients undergoing maintenance hemodialysis: study protocol for a randomized controlled trial

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Abstract

Background

Methods

Discussion

Trial registration:

Figures

Background

Method

Study design

Sample size calculation

Protocol Development

Study population

Eligibility criteria

Recruitment

Baseline assessment

Randomization, allocation concealment and blinding

Intervention protocol

Control group

Five-element music group

Western music group

Outcome measures

Primary outcome measure

Secondary outcome measures

Adverse events

Statistical analysis

Data collection and management

Discussion

Trial status

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

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