Musical Intervention on Stress Effects in Critically Ill Patients
NCT ID: NCT06120660
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-10-14
2025-12-31
Brief Summary
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Detailed Description
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Variables: The main variable will be total serum cortisol, prolactin, interleukin-6 levels. Secondary variables: secondary variables will be those used to measure physiological parameters to assess the patient's hemodynamic status of the patient in relation to the intervention.
Data collection: There will be 2 groups: intervention and control. The sample will be randomized as patients are admitted. First, they will be receiving the corresponding daily care. The first group of patients will receive the corresponding daily care. The patients in the intervention group will start the music therapy session through headphones, the patients in the control group will remain relaxed without any interruption during this time. All the variables will be collected before starting the study, during the study and at the end of the study.
Data analysis: A descriptive analysis of each variable will be performed. Subsequently, a bivariate analysis, previously checking the normality and homoscedasticity of the data.and homoscedasticity of the data. If statistically significant, post-hoc tests will be performed using Dunn's test.Dunn's test. Statistical significance will be accepted when p ≤ 0.05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Case Group
Music
Music Therapy
Music Therapy
Control Group
No interventions assigned to this group
Interventions
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Music Therapy
Music Therapy
Eligibility Criteria
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Inclusion Criteria
* Admitted to the ICU for a minimum of 24 hours
* Intubated patients undergoing invasive mechanical ventilation
* Arterial catheter carriers / central venous catheter
* Sedation level: BIS: 40 - 60
* No pain at the time of and during the procedure, which will be measured by a score of 0 on ESCID scale
* Not having previously undergone any other musical intervention.
Exclusion Criteria
* Severe psychiatric illness
* Suspected or confirmed drug or alcohol overdose/intoxication/abstinence
* Hearing impairment
* Skull lesions that preclude the use of headphones
* Patients with limitation of therapeutic effort or death expected within 24 hours
* Brain death diagnosis
* Failure to obtain informed consent from the legal representative within 72 hours of presentation
* Refusal of the responsible physician.
18 Years
ALL
No
Sponsors
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Sociedad Española de Enfermería Intensiva y Unidades Coronarias
UNKNOWN
University of Oviedo
OTHER
Responsible Party
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Alba Maestro Gonzalez
Principal Investigator
Principal Investigators
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Alba Maestro-González, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Oviedo
Locations
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Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Erdogan Z, Atik D. Complementary Health Approaches Used in the Intensive Care Unit. Holist Nurs Pract. 2017 Sep/Oct;31(5):325-342. doi: 10.1097/HNP.0000000000000227.
Umbrello M, Sorrenti T, Mistraletti G, Formenti P, Chiumello D, Terzoni S. Music therapy reduces stress and anxiety in critically ill patients: a systematic review of randomized clinical trials. Minerva Anestesiol. 2019 Aug;85(8):886-898. doi: 10.23736/S0375-9393.19.13526-2. Epub 2019 Apr 3.
Thaut MH. Music as therapy in early history. Prog Brain Res. 2015;217:143-58. doi: 10.1016/bs.pbr.2014.11.025. Epub 2015 Jan 31.
Seyffert S, Moiz S, Coghlan M, Balozian P, Nasser J, Rached EA, Jamil Y, Naqvi K, Rawlings L, Perkins AJ, Gao S, Hunter JD 3rd, Khan S, Heiderscheit A, Chlan LL, Khan B. Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial. Trials. 2022 Jul 19;23(1):576. doi: 10.1186/s13063-022-06448-w.
Kakar E, Billar RJ, van Rosmalen J, Klimek M, Takkenberg JJM, Jeekel J. Music intervention to relieve anxiety and pain in adults undergoing cardiac surgery: a systematic review and meta-analysis. Open Heart. 2021 Jan;8(1):e001474. doi: 10.1136/openhrt-2020-001474.
Khan SH, Wang S, Harrawood A, Martinez S, Heiderscheit A, Chlan L, Perkins AJ, Tu W, Boustani M, Khan B. Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial. Trials. 2017 Nov 29;18(1):574. doi: 10.1186/s13063-017-2324-6.
Khan SH, Kitsis M, Golovyan D, Wang S, Chlan LL, Boustani M, Khan BA. Effects of music intervention on inflammatory markers in critically ill and post-operative patients: A systematic review of the literature. Heart Lung. 2018 Sep-Oct;47(5):489-496. doi: 10.1016/j.hrtlng.2018.05.015. Epub 2018 Jul 9.
Taets GGC, Jomar RT, Abreu AMM, Capella MAM. Effect of music therapy on stress in chemically dependent people: a quasi-experimental study. Rev Lat Am Enfermagem. 2019 Jan 17;27:e3115. doi: 10.1590/1518-8345.2456.3115.
Other Identifiers
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Investiga SEEIUC 2023
Identifier Type: OTHER
Identifier Source: secondary_id
2022.537
Identifier Type: -
Identifier Source: org_study_id
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