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

Pain Clinical Trial

Official title:

The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters in Patients Receiving Ventilator Support in Intensive Care

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05082623
• Other study ID #: Music in intensive care
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: October 2021

Study information

• Verified date: October 2021
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: October 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Delirium
• Intensive Care Unit Delirium
• Music
• Pain
• Sedation

Intervention

Other:
• Music
Music medicine
• Earplug
Earplug with noise cancelling

Locations

Country	Name	City	State
Turkey	Ege University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of ICU stay	The total days of ICU stay.	During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)
Other	Duration of mechanical ventilation	The total days of mechanical ventilation.	During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)
Other	Delirium duration	The delirium duration will be calculated when the patient is first considered to have delirium to the last time that patient is not supposed to have delirium based on CAM-ICU.	During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)
Primary	Delirium	The delirium event assessed twice daily by trained research nurse using the CAM-ICU. The diagnosis of delirium is based on the presence of two major criteria (i.e. acute or fluctuating onset plus lack of attention) and at least one of the minor criteria (disorganized thinking or altered consciousness level).	Date of study enrollment through 12 months.
Secondary	Delirium severity	In case of positive delirium, its severity assessed twice daily by trained research nurse using the CAM-ICU-7. CAM-ICU-7 is a seven point scale (0-7), derived from the RASS and the CAM-ICU.	2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Secondary	Pain severity	Pain assessed by trained research nurse utilizing the Critical Care Pain Observation Tool (CPOT) a valid and reliable instrument in critically ill patients with and without delirium. The CPOT has 4 components: facial expression, body movements, muscle tension, and compliance with the ventilator for intubated patients or vocalization for extubated patients. Each component is scored from 0 to 2 with a possible total score ranging from 0 to 8. A CPOT = 3 is indicative of significant pain.	2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Secondary	Need of sedation	Sedation level assessed by trained research nurse using the Richmond Agitation-Sedation Scale (RASS). It is a ranking scale with 10-level (+4 "combative" to -5 "unarousable") used to measure the agitation or sedation level of a person.	2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Secondary	Anxiety level	Anxiety level assessed by trained research nurse using Face Anxiety Scale. The scale is composed of five face types. The face type in the left-hand corner indicates an absence of anxiety, while anxiety increases towards the faces in the right-hand corner. When patient scores were three or above, their anxiety was determined to be medium to high.	2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Secondary	Systolic/diastolic blood pressure	Changes in the systolic/diastolic blood pressure (mm/Hg). Blood pressure was recorded from monitor of patient.	2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Secondary	Heart rate	Changes in the heart rate. Heart rate was measured as number of heartbeats in a per minute from monitor of patient.	2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Secondary	Respiratory rate	Changes in the respiratory rate. Respiratory rate was measured as number of breaths in a per minute from monitor of patient.	2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization
Secondary	Oxygen saturation	Changes in the oxygen saturation. Saturation was recorded from monitor of patient.	2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization