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

NCT05082623 | Unknown DMC

• 1 other identifier: Music in intensive care
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

delirium; intensive care; music

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Delirium severity

  2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization

• Pain severity

  2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization

• Need of sedation

  2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization

• Anxiety level

  2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization

• Systolic/diastolic blood pressure

  2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization

Other Outcomes (3)

• Length of ICU stay

  During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)

• Duration of mechanical ventilation

  During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)

• Delirium duration

  During ICU stay (from randomization until ICU discharge, or death, or 1 year follow-up)

Study Arms (3)

Music group

EXPERIMENTAL

"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.

Other: Music

Earplug group

ACTIVE COMPARATOR

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.

Other: Earplug

Control group

NO INTERVENTION

The control group involves neither music intervention nor using earplug.

Interventions

Music OTHER

Music medicine

Music group

Earplug OTHER

Earplug with noise cancelling

Earplug group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Delirium; Pain; Anxiety Disorders

Interventions

Music Therapy; Ear Protective Devices

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 19, 2021
• Study Start: September 14, 2020
• Primary Completion: September 14, 2021
• Study Completion: October 1, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

TU (1)