Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-03 @ 11:06 PM
Study NCT ID:
NCT06120660
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Musical Intervention on Stress Effects in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-01', 'studyFirstSubmitDate': '2023-10-14', 'studyFirstSubmitQcDate': '2023-11-01', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'levels of serum cortisol', 'timeFrame': 'Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.', 'description': 'µg/dL'}, {'measure': 'levels of prolactin', 'timeFrame': 'Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.', 'description': 'ng/mL'}, {'measure': 'levels of interleukin 6', 'timeFrame': 'Only one intervention per person will be performed. Serum levels will be measured before and after the intervention. That is, at minute 0 and 60.', 'description': 'pg/mL'}], 'secondaryOutcomes': [{'measure': 'Bispectral Index (BIS)', 'timeFrame': 'Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.', 'description': 'From 0 to 100'}, {'measure': 'Blood Pressure', 'timeFrame': 'Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.', 'description': 'mmHg'}, {'measure': 'Heart rate', 'timeFrame': 'Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.', 'description': 'bpm'}, {'measure': 'Respiratory rate', 'timeFrame': 'Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.', 'description': 'breaths per minute'}, {'measure': 'Oxygen Saturation', 'timeFrame': 'Only one intervention per person will be performed. This variable will be recorded during the intervention, every 10 minutes. That is, at minute , 10, 20, 30, 40, 50 and 60.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['music therapy', 'anxiety', 'critical care', 'nursing', 'stress, psychological', 'respiration, artificial'], 'conditions': ['Critical Care', 'Respiration, Artificial', 'Sedation']}, 'referencesModule': {'references': [{'pmid': '28786890', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30947484', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25725914', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35854358', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33495383', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '29187230', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30001799', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30698217', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Aim: To evaluate the effects of a musical intervention on serum cortisol, prolactin, interleukin-6 levels and physiological parameters in sedated patients undergoing invasive mechanical ventilation.', 'detailedDescription': "Design, Setting and Study Subjects: A randomized clinical trial will be conducted in the ICU of a spanish tertiary hospital. The study subjects will be adults, intubated, subjected to invasive mechanical ventilation, arterial catheter undergoing invasive mechanical ventilation, carrying an arterial catheter, with an adequate level of sedation and who do not present pain during the intervention.\n\nVariables: 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.\n\nData 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.\n\nData 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults\n* Admitted to the ICU for a minimum of 24 hours\n* Intubated patients undergoing invasive mechanical ventilation\n* Arterial catheter carriers / central venous catheter\n* Sedation level: BIS: 40 - 60\n* No pain at the time of and during the procedure, which will be measured by a score of 0 on ESCID scale\n* Not having previously undergone any other musical intervention.\n\nExclusion Criteria:\n\n* Severe neurological disease or injury (CNS pathologies such as encephalitis, diffuse axonal injury, etc.)\n* Severe psychiatric illness\n* Suspected or confirmed drug or alcohol overdose/intoxication/abstinence\n* Hearing impairment\n* Skull lesions that preclude the use of headphones\n* Patients with limitation of therapeutic effort or death expected within 24 hours\n* Brain death diagnosis\n* Failure to obtain informed consent from the legal representative within 72 hours of presentation\n* Refusal of the responsible physician.'}, 'identificationModule': {'nctId': 'NCT06120660', 'briefTitle': 'Musical Intervention on Stress Effects in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Oviedo'}, 'officialTitle': 'Musical Intervention on Stress Effects in Critically Ill Patients', 'orgStudyIdInfo': {'id': '2022.537'}, 'secondaryIdInfos': [{'id': 'Investiga SEEIUC 2023', 'type': 'OTHER', 'domain': 'SEEIUC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case Group', 'description': 'Music', 'interventionNames': ['Other: Music Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Music Therapy', 'type': 'OTHER', 'description': 'Music Therapy', 'armGroupLabels': ['Case Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Alba Maestro-González, Ph.D.', 'role': 'CONTACT', 'email': 'maestroalba@uniovi.es', 'phone': '+34662186658'}, {'name': 'Alba Maestro-González, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Zuazua-Rico, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'M.Pilar Mosteiro-Díaz, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marta Sánchez-Zaballos, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carmen Fernández-Álvarez, RN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}], 'centralContacts': [{'name': 'Alba Maestro-González, Ph.D.', 'role': 'CONTACT', 'email': 'maestroalba@uniovi.es', 'phone': '+34662186658'}], 'overallOfficials': [{'name': 'Alba Maestro-González, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oviedo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the data are confidential due to the sensitivity of the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oviedo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sociedad Española de Enfermería Intensiva y Unidades Coronarias', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alba Maestro Gonzalez', 'investigatorAffiliation': 'University of Oviedo'}}}}