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

NCT05729997 | Completed

• 1 other identifier: 2018/0526
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Haemodialysis

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group listened for 4 weeks to live classical music during HD sessions lasting 30 to 40 minutes each.

Other: Listening to live classical music

Control group

NO INTERVENTION

the control group carried out the usual treatment

Interventions

Listening to live classical music OTHER

The group of musicians perform music in the hemodialysis room while patients receive treatment.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Hospital universitario y politecnica La Fe

Valencia, 46026, Spain

Location

Related Publications (1)

• 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.

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mserranosoliva

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 15, 2023
• Study Start: January 14, 2019
• Primary Completion: March 31, 2019
• Study Completion: January 31, 2020
• Last Updated: June 9, 2023

Record last verified: 2023-06

Locations

ES (1)