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

June 7, 2023 updated by: Miriam Serrano Soliva, Hospital Universitario La Fe

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Hospital universitario y politecnica La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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
The group of musicians perform music in the hemodialysis room while patients receive treatment.
No Intervention: Control group
the control group carried out the usual treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Result variable:health-related quality of life (HRQL)
Time Frame: 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.

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
Time Frame: 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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2019

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

February 4, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

June 7, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/0526

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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