Chronic Kidney DiseasesNCT05729997
Live Classical Music and the Response to the Disease and Its Evolution in Patients With Chronic Renal Failure
A study testing Listening to live classical music in people with Chronic Kidney Diseases and Haemodialysis, run by Hospital Universitario La Fe at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Haemodialysis
- What is being tested?
- Listening to live classical music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jan 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age.
- Signed informed consent.
- To be more than 3 months in the chronic HD program.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Kidney Diseases, Haemodialysis
- Being tested
- Listening to live classical music
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to live classical musicOther
The group of musicians perform music in the hemodialysis room while patients receive treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group listened for 4 weeks to live classical music during HD sessions lasting 30 to 40 minutes each. Receives: Other: Listening to live classical music |
| Control group | No intervention | the control group carried out the usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start14 Jan 2019
- Primary completion31 Mar 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Serrano Soliva, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729997
- Sponsor's protocol ID
- 2018/0526
- Status last verified
- Jun 2023
- First submitted
- 4 Feb 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36739245
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- La música clásica en Directo y la Respuesta Frente a la Enfermedad y su evolución en Pacientes Con Insuficiencia Renal crónica
- ClinicalTrials.gov ID
- NCT05729997
- Acronym / sponsor ID
- 2018/0526
- Conditions
- Chronic Kidney Diseases, Haemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Listening to live classical musicThe intervention group listened for 4 weeks to live classical music during HD sessions lasting 30 to 40 minutes each. |
| Control group | No intervention | –the control group carried out the usual treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age.
- Signed informed consent.
- To be more than 3 months in the chronic HD program.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listening to live classical musicThe group of musicians perform music in the hemodialysis room while patients receive treatment. | Other | Intervention group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Results publication: PubMed 36739245Soliva 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to live classical music in people with Chronic Kidney Diseases and Haemodialysis, run by Hospital Universitario La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.