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

Primary Purpose

Chronic Kidney Diseases, Haemodialysis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Listening to live classical music
Sponsored by
Hospital Universitario La Fe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital universitario y politecnica La Fe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

the control group carried out the usual treatment

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 4, 2023
Last Updated
June 7, 2023
Sponsor
Hospital Universitario La Fe
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1. Study Identification

Unique Protocol Identification Number
NCT05729997
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Fe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Haemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group listened for 4 weeks to live classical music during HD sessions lasting 30 to 40 minutes each.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
the control group carried out the usual treatment
Intervention Type
Other
Intervention Name(s)
Listening to live classical music
Intervention Description
The group of musicians perform music in the hemodialysis room while patients receive treatment.
Primary Outcome Measure Information:
Title
Result variable:health-related quality of life (HRQL)
Description
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.
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.
Title
Result Variable: Anxiety and depression
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Hospital universitario y politecnica La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
36739245
Citation
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;42(5):559-567. doi: 10.1016/j.nefroe.2021.07.010. Epub 2023 Feb 2.
Results Reference
result
Links:
URL
https://doi.org/10.1016/j.nefro.2021.07.019
Description
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Live Classical Music and the Response to the Disease and Its Evolution in Patients With Chronic Renal Failure

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