Live Classical Music and the Response to the Disease and Its Evolution in Patients With Chronic Renal Failure

Chronic Kidney Diseases Clinical Trial

Official title:

La música clásica en Directo y la Respuesta Frente a la Enfermedad y su evolución en Pacientes Con Insuficiencia Renal crónica

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05729997
• Other study ID #: 2018/0526
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2023
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 31, 2020
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Haemodialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Listening to live classical music
The group of musicians perform music in the hemodialysis room while patients receive treatment.

Locations

Country	Name	City	State
Spain	Hospital universitario y politecnica La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Soliva MS, Salvador IR, Testal AG, Lopez CC, Ramon RO, Coca JV, Maset RG. Intervention study to verify the effect of live classic music during hemodialysis on the quality of life of patients with chronic kidney disease. Nefrologia (Engl Ed). 2022 Sep-Oct; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Result variable:health-related quality of life (HRQL)	Measured with the Kidney Diseasse health questionnaire Quality of life (KDQOL-SF) before and after the musical intervention.; The scale includes 11 specific dimensions for kidney disease, the score for each dimension ranges from 0 to 100, where higher scores represent better health status, except in the specific scale of cognitive function and quality of social relationships where the highest score represents worse health status.	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.
Primary	Result Variable: Anxiety and depression	Measured whith the questionnaire Hospital Anxiety and Depression Scale (HAD) It is a self-administered questionnaire, composed of 14 questions divided into 2 subsections, one for the Anxiety scale (HAD-A) with 7 items and the other for the Depression scale (HAD-D) with 7 more items.; For both scales, the score obtained results from the sum of each item, with the following ratings being considered in their evaluation; No case (NC) from 0 to 7; Doubtful Case (CD) from 8 to 10; Case (C) from 11 to the maximum value of 21.	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.

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