The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters

NCT ID: NCT05082623

Last Updated: 2021-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2021-10-31

Brief Summary

The purpose of this study is to test the effect of a twice daily, 60-minute, nurse initiated, music listening intervention on patients followed in the ICU with MV support as compared to patients who receive care as usual and ear plugs.

Detailed Description

Delirium is an acute disorder of consciousness and cognitive function that occurs frequently in critical care settings. Many critically ill patients (e.g., up to 80% of patients) experience ICU delirium due to underlying medical or surgical health problems, recent surgical or other invasive procedures, medications, or various noxious stimuli (e.g., underlying psychological stressors, mechanical ventilation [MV], noise, light, patient care interactions, and drug-induced sleep disruption or deprivation). Delirium contributes to adverse outcomes such as increased mortality and morbidity, longer length of ICU stays, prolonged MV, costlier hospitalizations, and cognitive impairment after hospital discharge. The Society of Critical Care Medicine (SCMM) Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU (PADIS) recommend non-pharmacological interventions of preventing delirium and other symptoms. Music, which is one of the non-pharmacological applications, is one of the cognitive-behavioral treatment methods applied in the field of ICU as in many other fields. Music is easy method to apply and has no side effects and contributes to physical, psychological, emotional and spiritual healing. In the literature, it is seen that music intervention studies applied to patients followed in the ICU mostly focus on the effects on anxiety, pain, non-invasive ventilation tolerance, and stress response (heart rate, blood pressure, respiratory rate). The relationship between intensive care delirium and all these symptoms (pain, agitation, anxiety, stress response, etc.) and their interaction with each other have been clarified in the light of evidence-based guidelines and studies. Therefore, the aim of this study is to examine the effects of music applied to patients followed in the ICU with MV support on delirium, pain, need for sedation, anxiety and vital parameters.

Conditions

Delirium; Pain; Sedation; Anxiety; Music; Intensive Care Unit Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Music group

"MusiCure®" compositions specially composed for the music group will be performed twice a day, between 10.00-11.00 a.m. and 14.00-15.00 p.m., for five days with headphones and a music player. Before the application, the sound level of the ICU environment will be measured with a decibel meter. At the 0th minute of the music application, at the 30th minute after starting the music, and at the 60th minute after the end of the music, the characteristics of delirium, pain, sedation level, anxiety and vital parameters will be recorded with data collection tools.

Group Type: EXPERIMENTAL

Music

Intervention Type: OTHER

Music medicine

Earplug group

In this group, patients will be given only earplugs. Before the application, the sound level of the ICU environment will be measured with a decibel meter. At the 0th minute of the intervention, at the 30th minute after starting intervention, and at the 60th minute after the end of the intervention, the characteristics of delirium, pain, sedation level, anxiety and vital parameters will be recorded with data collection tools.

Group Type: ACTIVE_COMPARATOR

Earplug

Intervention Type: OTHER

Earplug with noise cancelling

Control group

The control group involves neither music intervention nor using earplug.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music

Music medicine

Intervention Type: OTHER

Earplug

Earplug with noise cancelling

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥18 years,
• Admitted to the ICU as of the start of the study and planned to be followed up in the ICU for at least 24 hours,
• Needing invasive MV for at least 24 hours,
• Pre-deliric score > 20%
• At least one positive delirium according to CAM-ICU,
• GCS score > 8,
• RASS score ≥ -3,
• Hemodynamically stable,
• CPOT score ≥ 3

Exclusion Criteria

• Hearing or vision problems,
• Diagnosed with psychiatric illness,
• Diagnosed with dementia,
• Having acute neurological injury,
• Alcohol/drug poisoning
• Hemodynamically unstable and treated with high-dose inotropic/vasopressor medication,
• Pregnant,
• Planned to be followed in ICU for less than 24 hours,
• Does not need MV,
• GCS score ≤ 8,
• RASS score < -3,
• Patients referred from another ICU

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Öznur ERBAY DALLI

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ege University

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Music in intensive care

Identifier Type: -

Identifier Source: org_study_id