Clinical trial NCT05729997: Live Classical Music and the Response to the Disease and Its Evolution in Patients With Chronic Renal Failure
Official title: La música clásica en Directo y la Respuesta Frente a la Enfermedad y su evolución en Pacientes Con Insuficiencia Renal crónica
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Haemodialysis
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People are most vulnerable to anxiety when faced with life-threatening situations such as illness, medical treatments and surgeries. When a person becomes ill, he and his family must face a series of changes in their life habits, must cope with admissions, aggressive treatments and endure physical pain. These changes can generate an unfavorable state of mind to face the disease, which sometimes worsens the previous clinical situation. The direct effect of music has been studied in different pathologies during the last years.

The proposed research sought to provide information on the influence of classical music listened to live and in situ in the hospital, and the response to the disease and its evolution, in patients with chronic renal failure. For this purpose, the effect of live music performances in hemodialysis rooms was analyzed and changes in the patients' mood and quality of life were observed. Changes in vital sign recording were also observed, all of which were assessed before and after the interventions. Finally, we checked if there were any changes in the variables described as confounders (KT/V-Albumin-Hemoglobin-Blood Pressure-Consumption of psychotropic drugs and analgesics), which could be attributable to listening to music.To test the effect in patients with chronic renal failure, live classical music was listened to in the hospital, as an adjuvant to treatment during haemodialysis processes. Ninety patients participated in 2 groups, the intervention group that listened to music during haemodialysis sessions and the control group that continued with their usual treatment. Changes in anxiety and mood were analyzed by means of the quality of life questionnaire (HAD) and quality of life by spheres with the KDQOL-SF questionnaire, before and after the intervention in both groups.

To test the effect in patients with chronic renal failure, live classical music was listened to in the hospital, as an adjuvant to treatment during haemodialysis processes. Ninety patients participated in 2 groups, the intervention group that listened to music during haemodialysis sessions and the control group that continued with their usual treatment. Changes in anxiety and mood were analyzed by means of the quality of life questionnaire (HAD) and quality of life by spheres with the KDQOL-SF questionnaire, before and after the intervention in both groups.


Eligibility criteria: Inclusion criteria:

* Patients over 18 years of age.
* Signed informed consent.
* To be more than 3 months in the chronic HD program.

Exclusion criteria:

* Inability to listen to music.
* Inability to answer the surveys.
* Failure to sign informed consent to participate.
* under 18 years of age.
* hospital admissions for more than 4 weeks or in the last two weeks of the intervention.

Primary outcomes:
measure: Result variable:health-related quality of life (HRQL)
timeFrame: During the 1 month period, live musical performances were held in the HD rooms in two of the three weekly sessions. The musical sessions lasted about 30/40 min.
measure: Result Variable: Anxiety and depression
timeFrame: During the 1 month period, live musical performances were held in the HD rooms in two of the three weekly sessions. The musical sessions lasted about 30/40 min.
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital universitario y politecnica La Fe
Study officials:
References:
citation: Soliva, MS, Salvador, IR, Testal, AG, López, CC, Ramón, RO, Coca, JV, & Maset, RG (2022). Estudio de intervención para comprobar el efecto de la música clásica en directo durante la hemodiálisis sobre la calidad de vida de los pacientes con enfermedad renal crónica. nefrología , 42 (5), 559-567.