Impact of music therapy on diabetes distress and bio-physiological parameters in patients with diabetic foot ulcer

Abstract

BACKGROUND:

Diabetic foot ulcer (DFU) is a common and significant complication of uncontrolled diabetes mellitus (DM), frequently resulting in increased physiological suffering and emotional burden. Music therapy, as a complementary intervention, has shown potential in lowering stress and improving general well-being, but its influence on patients with DFU is unknown. The present study aimed to identify the impact of music therapy on diabetes distress and bio-physiological parameters among patients with DFU.

METHODS AND MATERIALS:

The study was conducted in a selected tertiary care hospital in South India, and a Quasi-experimental pretest-posttest control group research design was used. A non-probability purposive sampling was used to select 159 participants with DFU into three groups: Group I (n = 53) received patient-selected music therapy, Group II (n = 53) received researcher-selected music, and the control group (n = 53) received routine treatment only. The intervention involved listening to music for 20 minutes twice daily over 21 consecutive days, along with standard medical care. Ethical clearance was obtained from the institutional review board and ethics committee. Data were analyzed by descriptive and inferential statistics using SPSS version 26.

RESULTS:

The study shows a statistically significant (p ˂ 0.001) difference within Groups I, II, compared to the control group for diabetes distress and all the bio-physiological parameters. However, the mean posttest scores of diabetes distress and bio-physiological parameters in Groups I and II were considerably reduced from the mean pretest scores compared to the control group.

CONCLUSION:

The study finding helps to integrate music therapy as a complementary therapy for people with DFU to preserve good physical and mental health.

Introduction

Diabetes mellitus (DM) is one of the leading causes of morbidity and mortality, and the incidence rate is increasing rapidly, resulting in an epidemic.[1] Ninety-five percent of people with DM have type 2 diabetes mellitus (T2DM), which is more common in adults because of increasing obesity and a decrease in activity.[2] According to the International Diabetes Federation (IDF), around 589 million people had DM in the year 2015, and it is expected to rise to 853 million by 2050.[3] The statistical report in 2021 shows that 531 million adults were suffering from DM.[4] The prevalence of DM in India stood at 9.3% in 2018, according to a report by the National Non-communicable Disease Monitoring Survey (NNMS).[5]

According to the World Health Organization (WHO) statistics, in 2022, 14% of adults aged 18 and older were diagnosed with DM, up from 7% in 1990. Over half (59%) of adults aged 30 and older with DM were not on any diabetes medication in 2022. The lowest rates of diabetes treatment coverage were found in low- and middle-income countries. In 2021, diabetes directly resulted in 1.6 million deaths, with 47% of all diabetes-related deaths occurring before the age of 70.[6]

An increase in glycemic levels increases the risk for microvascular and macrovascular complications.[7] Diabetic foot ulcer (DFU) is the most common complication associated with DM,[8,9] and it is the leading cause of lower limb amputation.[10] Various lower limb complications in DM patients are DFU, infections, and lower extremity amputations.[11] Successful management of DFU needs prolonged treatment, which brings about restrictions on daily activities and leads to a negative influence on mental health and quality of life.[12] DFU patients are at risk of getting anxiety, depression, and diabetes distress (DD).[13]

Patients with DM are frequently exposed to stressful situations. Stress can cause an increase in hormones, which results in an increase in blood sugar and blood pressure. The higher the stress level, the higher the blood sugar and blood pressure. So, if a DM patient experiences stress, it can have an impact on the bio-physiological parameters.[14]

According to estimates, mortality from DFUs is 5% in the first 12 months and 42% in the first five years after the illness develops.[15] Every 30 seconds, a major amputation occurs for patients with infected diabetic feet, and 2,500 extremities are lost daily globally.[16] A more favorable prognosis can be achieved through the accurate diagnosis of DFU and the timely application of the right treatment.[17] Complications related to DM continue to be a significant cause of morbidity and mortality despite current standards of care.[18] Due to various reasons, patients may supplement their medical treatment with alternative applications. Complementary Alternative Management (CAM) is such an application.[19]

Music therapy is shown to provide potential benefits in a variety of fields, including health care, education, and social welfare, in addition to the artistic and cultural benefits it already offers. It is now practiced for reducing blood sugar levels in wounded patients with DM.[20] It is used as an adjuvant for healing and symptom management.[21]

Classical music is shown to increase the activity of β-cells in the Islets of Langerhans in the pancreas, which in turn maintains normalcy for a specific amount of time. It has been shown that listening to classical music can subtly affect the activity of the neurotransmitter adrenaline, which helps in the reduction of glycemic levels.[22] Music therapy may have an effect on bio-physiological markers such as fasting blood glucose (FBS) and blood pressure; the evidence is limited, especially in certain chronic diabetes complications.[23] According to recent studies, Karnataka has witnessed a significant increase in diabetes cases and complications, particularly in urban areas.[24]

The patients with DFU may have DD and variations in physiological parameters, according to research studies. Unlike previous studies, which focused primarily on general diabetic populations or short-term effects, the current study investigates the impact of both patient-preferred and researcher-selected music therapy on diabetes-related distress and bio-physiological outcomes in patients with diabetic foot ulcer (DFU), a high-risk subgroup. By targeting this vulnerable population, the study aims to fill a critical gap in the literature and provide evidence for integrating music therapy as a complementary approach in routine DFU management.

Subjects and Methods

Study design and setting

A quasi-experimental pretest-posttest control group research design was adopted for this study. The research was conducted in a selected multi-specialty tertiary care hospital in Mangaluru. The study involved three groups: Group I (patient-selected music), Group II (researcher-selected music), and a control group. The pretest was conducted on Day 1, and the posttests were conducted on Day 15 and Day 21.

Study participants and sampling

The study population consisted of 159 patients with diabetic foot ulcer (DFU). The sample size was calculated based on an anticipated effect size of 1.5, with 80% power, two repeated measures, and a 5% level of significance.[25] Considering a 10% attrition rate, a total of 159 patients were recruited using a non-probability purposive sampling technique.

Subjects were matched based on age, gender, and ulcer grade. Participants who met the inclusion criteria and were interested in listening to music were assigned to Group I or II, while those not interested in music were assigned to the control group.

Inclusion criteria

The study included patients with DFU aged above 18 years. Those interested in listening to music were assigned to Group I and II, while those not interested were assigned to the control group. Eligible patients had grade 2 or 3 DFU as per Wagner’s classification and were on stabilized antidiabetic therapy for at least three consecutive days, with insulin dose variations not exceeding 12 units/day.

Exclusion criteria

Patients with DFU were excluded if they had FBS >190 mg/dL or <100 mg/dL, RBS >250 mg/dL or <140 mg/dL, were undergoing other complementary therapies, had profound hearing loss, major illness, or were critically ill.

Data collection tool and technique

The tools used for the study were the demographic and clinical proforma, diabetes distress scale (DDS-17),[26] checklist for monitoring physiological outcomes, and the instruments used were a calibrated glucometer and sphygmomanometer.

Intervention

Along with routine care, Group I received self-selected music and Group II researcher-provided music, while the control group received only standard hospital treatment. The music therapy intervention is outlined in Table 1.

Table 1.

Music therapy intervention program

Groups		Activities		Duration and frequency
Group 1		Participants listened to music on their mobile phones using earphones, which were provided if unavailable, and were instructed to use them while reclining in bed.		The intervention was administered twice daily for 20 minutes, between 7–8 am and 7–8 pm, over 21 consecutive days.
Group 2		Participants in Group II listened to instrumental music provided by the researcher via headsets with preloaded memory cards, while reclining in bed. The sessions included Raga Chakravakam and music chakras in the morning, and music chakras with Raga Yadukula Kamboji in the evening.[27,28]		The intervention was administered twice daily for 20 minutes, between 7–8 am and 7–8 pm, over 21 consecutive days.

Ethical consideration

The study was approved by the Institutional Review Board and Ethics Committee, with formal permission from the hospital authority. Participants were fully informed, and written consent was obtained. It was also registered in the Clinical Trial Registry of India (CTRI/2020/11/028857). The detailed study plan is illustrated in Figure 1.

Figure 1.

Schematic representation of the study plan

Statistical analysis

Data were analyzed using descriptive and inferential statistics in line with the study objectives and hypotheses. Demographic and clinical characteristics were summarized using frequency and percentage, while pretest scores of DD and bio-physiological parameters were described with mean, median, mean percentage, and standard deviation. The effectiveness of music therapy on DD was assessed using a paired t-test within groups and a one-way ANOVA between groups. Bio-physiological parameters were analyzed using repeated measures ANOVA within groups and one-way ANOVA between groups across time points. All analyses were performed using SPSS version 26.

Results

Most participants were above 60 years (52.8%), with a mean age of around 61 years across all groups, and the majority (73.6%) were male. Education levels vary, with more participants in Group I having no formal education (35.8%), while primary education was common in Group II and the control group (54.7%). Most were married, especially in Group II (96.2%). Employment patterns showed self-employment as most common in Groups I (34.0%) and II (45.3%), while the control group had a balance of private (32.1%) and self-employed (30.2%) participants. Duration since diagnosis was longer in Group I (≥6 years: 37.7%), while Groups II (52.8%) and control (50.9%) had more participants diagnosed within 3–6 years. A positive family history of diabetes was highest in the control group (60.4%), compared to Group II (43.4%) and Group I (35.8%).

Among the 159 participants (n = 53 in each group), nearly half in all groups had grade 2 ulcers (47.2%) and slightly more than half had grade 3 ulcers (52.8%). Co-morbidities were reported by 22.6% in Group I, 32.1% in Group II, and 20.8% in the control group, with hypertension being the most common (50% in Group I, 56.5% in Group II, and 76.9% in the control group). Other co-morbidities included arthritis, CHF, CKD, dyslipidemia, low back pain, neuropathy, PVD, and retinopathy, though their distribution varied across groups and was comparatively less frequent.

Figure 2 depicts the overall diabetes distress scores within three study groups—Group I, Group II, and the Control group—measured before and after music therapy intervention. Paired t-test (t) was used to analyze the data. Following the intervention, the distress levels in both Group I and Group II showed a significant reduction. The results suggested that the music therapy administered to Group I and Group II was effective in significantly reducing diabetes-related distress.

Figure 2.

Diabetes distress score within the groups

Table 2 shows that both Group I and Group II had significant reductions in all four domains of diabetes distress—especially emotional burden and regimen-related distress (P < 0.001)—with mild but significant declines in physician-related distress. The control group showed minimal or no significant changes, indicating the effectiveness of the interventions in Groups I and II.

Table 2.

Intragroup comparison of domain-wise DD scores in the study groups n=(53+53+53)

Domains of Diabetes Distress		Study groups		Observations				Statistical value
				Pretest		Posttest		t		P
Emotional burden		Group I		3.42±0.41		2.54±0.62		11.92		<0.001***
		Group II		3.36±0.38		2.57±0.55		10.38		<0.001***
		Control		3.30±0.37		3.34±0.34		-1.46		0.151
Physician related distress		Group I		1.37±0.38		1.32±0.30		2.29		0.026*
		Group II		1.38±0.47		1.34±0.42		2.81		0.007**
		Control		1.29±0.27		1.30±0.23		-0.23		0.821
Regimen related distress		Group I		4.06±0.32		2.71±0.80		14.18		<0.001***
		Group II		3.91±0.52		2.79±0.79		10.18		<0.001***
		Control		3.89±0.33		3.76±0.32		5.60		<0.001***
Interpersonal distress		Group I		2.43±0.42		1.77±0.49		10.07		<0.001***
		Group II		2.64±0.45		1.87±0.58		9.63		<0.001***
		Control		2.67±0.40		2.57±0.38		3.80		<0.001***

Minimum score is 1, maximum score is 6. *P<0.05 significant, **P<0.01 highly significant, ***P<0.001 very highly significant, P>0.05 non-significant

Table 3 shows that both Group I and Group II had significantly lower overall diabetes distress scores than the control group (P < 0.001), with the greatest improvements in emotional burden, regimen-related distress, and interpersonal distress. No significant difference was found between Group I and Group II, indicating equal effectiveness, while physician-related distress showed no significant changes across groups.

Table 3.

Groupwise comparison of posttest scores of overall and domain-wise DD between the study groups n=(53+53+53)

Domains of DDS-17				Study groups				Mean Difference		Statistical value, P
Overall Diabetes Distress score				Control Vs.		Group I		0.68		<0.001***
						Group II		0.63		<0.001***
				Group I Vs.		Group II		-0.05		0.796
Domains		Emotional burden		Control Vs.		Group I		0.80		<0.001***
						Group II		0.77		<0.001***
				Group I Vs.		Group II		-0.03		0.940
		Physician related distress		Control Vs.		Group I		-0.02		0.925
						Group II		-0.05		0.734
				Group I Vs.		Group II		-0.02		0.925
		Regimen related distress		Control Vs.		Group I		1.05		<0.001***
						Group II		0.98		<0.001***
				Group I Vs.		Group II		-0.07		0.848
		Interpersonal distress		Control Vs.		Group I		0.79		<0.001***
						Group II		0.70		<0.001***
				Group I Vs.		Group II		-0.09		0.584

Minimum score is 1, maximum score is 6. *P<0.05 significant, ***P<0.001 very highly significant, P>0.05 non-significant

Table 4 shows that both intervention groups had significant improvements in FBS, RBS, pulse rate, respiratory rate, and SBP (P < 0.001), with greater reductions from pretest to posttest 2. DBP showed moderate but non-significant changes. The control group showed minimal or inconsistent changes, indicating the interventions were effective in improving blood glucose and bio-physiological parameters.

Table 4.

Intragroup comparisons of bio-physiological parameters within the study groups at different points of observation n=(53+53+53)

Bio-physiological Parameters		Study groups		Observations
				Pretest Vs. Posttest 1				Pretest Vs. Posttest 2				Posttest 1 Vs. Posttest 2
				Mean difference		P		Mean difference		P		Mean difference		P
FBS		Group I		28.34		<0.001***		44.04		<0.001***		15.70		<0.001***
		Group II		29.76		<0.001***		44.66		<0.001***		14.91		<0.001***
		Control		4.59		<0.001***		33.57		<0.001***		28.98		<0.001***
RBS		Group I		9.72		<0.001***		35.93		<0.001***		26.21		<0.001***
		Group II		21.98		<0.001***		35.74		<0.001***		13.76		<0.001***
		Control		11.43		<0.001***		26.43		<0.001***		15.00		<0.001***
Pulse rate		Group I		5.32		<0.001***		6.45		<0.001***		1.13		0.004**
		Group II		5.51		<0.001***		6.94		<0.001***		1.43		<0.001***
		Control		0.42		0.374		1.47		<0.001***		1.06		0.001**
Respiratory rate		Group I		2.38		<0.001***		2.26		<0.001***		-0.11		1
		Group II		2.04		<0.001***		2.19		<0.001***		0.15		0.756
		Control		0.57		0.006**		0.72		0.003**		0.15		1
SBP		Group I		10.19		<0.001***		13.21		<0.001***		3.02		0.008**
		Group II		12.83		<0.001***		13.59		<0.001***		0.76		0.868
		Control		2.64		0.001**		3.21		<0.001***		0.57		0.966
DBP		Group I		0.38		0.478		1.89		0.009**		1.51		0.058
		Group II		1.13		0.098		2.64		<0.001***		1.51		0.011*
		Control		0.00		--		1.32		0.021*		1.32		0.021*

Level of significance: *P<0.05 significant, **P<0.01 highly significant, ***P<0.001 very highly significant P>0.05 non-significant

Table 5 shows that both intervention groups had significantly greater reductions in FBS, pulse rate, respiratory rate, and SBP compared to the control (P < 0.001), with Group II showing consistently better improvements, including significant RBS reduction at both posttests (P < 0.001). DBP changes were minimal, except for a significant reduction in Group II at Posttest 2 (P = 0.013). Overall, both interventions effectively improved glycemic and bio-physiological parameters, with Group II showing slightly better outcomes.

Table 5.

Groupwise comparison of posttest scores of biophysiological parameters between the study groups at different points of observation n=(53+53+53)

Bio-physiological Parameters		Observations		Study groups				Mean Difference		Statistical value, P
FBS		Posttest 1		Control Vs.		Group I		29.7		<0.001***
						Group II		44.7		<0.001***
				Group I Vs.		Group II		15.0		0.091
		Posttest 2		Control Vs.		Group I		13.4		0.001**
						Group II		19.0		<0.001***
				Group I Vs.		Group II		5.6		0.269
RBS		Posttest 1		Control Vs.		Group I		-10.21		0.104
						Group II		19.77		<0.001***
				Group I Vs.		Group II		29.98		<0.001***
		Posttest 2		Control Vs.		Group I		1.00		0.925
						Group II		18.53		<0.001***
				Group I Vs		Group II		17.53		<0.001***
Pulse rate		Posttest 1		Control Vs.		Group I		4.68		<0.001***
						Group II		4.72		<0.001***
				Group I Vs.		Group II		0.04		0.999
		Posttest 2		Control Vs.		Group I		4.75		<0.001***
						Group II		5.09		<0.001***
				Group I Vs.		Group II		0.34		0.916
Respiratory rate		Posttest 1		Control Vs.		Group I		1.28		<0.001***
						Group II		0.98		0.008**
				Group I Vs.		Group II		-0.30		0.621
		Posttest 2		Control Vs.		Group I		1.02		0.004**
						Group II		0.98		0.006**
				Group I Vs.		Group II		-0.04		0.992
SBP		Posttest 1		Control Vs.		Group I		7.17		<0.001***
						Group II		10.19		<0.001***
				Group I Vs.		Group II		3.02		0.110
		Posttest 2		Control Vs.		Group I		9.62		<0.001***
						Group II		10.38		<0.001***
				Group I Vs.		Group II		0.75		0.836
DBP		Posttest 2		Control Vs.		Group I		1.13		0.569
						Group II		3.21		0.013*
				Group I Vs.		Group II		2.08		0.154

Level of significance: *P<0.05 significant, **P<0.01 highly significant, ***P<0.001 very highly significant, P>0.05 non-significant

Discussion

The findings of the present study highlight a significant prevalence of diabetes distress (DD) among individuals with diabetic foot ulcers (DFU). Notably, 52.2% of participants experienced moderate levels of DD, while 47.8% reported no discomfort. These rates are substantially higher than those observed in previous studies involving general diabetic populations.[29,30] This suggests that the presence of DFU—a chronic, painful, and visually distressing complication of diabetes—may substantially elevate emotional burden and distress. These results reinforce the critical need for holistic patient care that includes emotional and psychological support, along with physiological management.

Music therapy proved to be an effective, low-cost complementary intervention, significantly reducing diabetes distress scores in both groups (P < 0.001), with patient-preferred music showing slightly greater impact. These results align with previous studies reporting reduced psychological distress and anxiety in T2DM and prediabetic individuals.[28,31]

In addition to emotional well-being, music therapy was found to positively influence glycemic control. Participants in the intervention groups showed notable reductions in both fasting blood sugar (FBS) and random blood sugar (RBS) levels compared to the control group. This aligns with previous research indicating that music therapy can support improved metabolic outcomes by reducing stress, promoting relaxation, and potentially influencing glucose metabolism.[20,28]

Moreover, the current study observed a significant decrease in pulse rate, respiratory rate, and blood pressure following the music therapy sessions. These outcomes support existing literature indicating that music can modulate the autonomic nervous system, promote parasympathetic activity, and induce a calming physiological response.[32,33,34] However, it is important to acknowledge that not all studies report consistent findings. For instance, some research involving patients with acute viral infections found no significant change in pulse rate post-intervention.[35] These inconsistencies may be attributed to variations in music selection, session duration, patient condition, or therapeutic environment.

From a physiological perspective, the hypothalamic-pituitary-adrenal (HPA) axis plays a key role in the body’s stress response. Chronic stress activates this axis, prompting the release of corticotropin-releasing hormone (CRH), adrenocorticotropic hormone (ACTH), and ultimately cortisol, which impacts glucose metabolism, inflammation, and immune responses.[36] Emerging research suggests that relaxing music may interrupt this stress cascade by reducing CRH and ACTH secretion, thereby lowering cortisol levels in the bloodstream.[37] These neuroendocrine effects may partially explain the observed improvements in emotional and physiological health outcomes.

Overall, the study highlights music therapy’s potential in reducing diabetes distress and improving physiological outcomes in diabetes, supporting its integration as a non-pharmacological, patient-centered approach to enhance holistic care.

Future research should examine the long-term benefits of music therapy across diverse populations, with randomized controlled trials needed to validate these findings and refine protocols for clinical use.

Limitation and recommendation

The study had certain limitations, as the depth of listening to music could not be assessed, and data monitoring was restricted to specific times of the day. Outcomes may also have been influenced by factors such as previous history of diabetic foot ulcer (DFU) and individual dietary habits affecting FBS and RBS levels. Moreover, the absence of follow-up limited the assessment of music therapy practice in participants’ day-to-day activities.

Future research can explore these areas further. A comparative study may be conducted to evaluate the effectiveness of different complementary therapies, while similar studies can be carried out in primary health care centers to assess their feasibility at the community level. Extending the study duration to three months would help identify changes in HbA1c levels, and further research could also examine the impact of music therapy on wound healing in patients with DFU.

Conclusion

Music therapy intervention showed a significant reduction in diabetes distress and improvement in bio-physiological parameters such as FBS, RBS, pulse rate, respiratory rate, and blood pressure. Hence, this study’s finding helps to integrate music therapy as a complementary therapy for people with diabetic foot ulcers to preserve good physical and mental health, and to maintain bio-physiological parameters at normal levels.

Author’s contributions

Synopsis drafted by all the authors. The principal investigator collected the data, and other investigators supervised it. All authors have approved the final version of the manuscript.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Self-funded.