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

Sponsor
Hospital Universitario La Fe (Other)
Overall Status
Completed
CT.gov ID
NCT05729997
Collaborator
(none)
90
1
2
12.6
7.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Listening to live classical music
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
La música clásica en Directo y la Respuesta Frente a la Enfermedad y su evolución en Pacientes Con Insuficiencia Renal crónica
Actual Study Start Date :
Jan 14, 2019
Actual Primary Completion Date :
Mar 31, 2019
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Result variable:health-related quality of life (HRQL) [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.

  2. Result Variable: Anxiety and depression [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital universitario y politecnica La Fe Valencia Spain 46026

Sponsors and Collaborators

  • Hospital Universitario La Fe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Miriam Serrano Soliva, mserranosoliva, Hospital Universitario La Fe
ClinicalTrials.gov Identifier:
NCT05729997
Other Study ID Numbers:
  • 2018/0526
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2023