Music and Essential Oil in Agitation

Study Overview
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Brief Summary
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The study aims to assess the effect of using music and essential oil on agitation in mechanically ventilated patients. Listening to classical relaxation music, and inhalation to bergamot oil will be used in this study.

Detailed Description
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Agitation in critically ill patients is a phenomenon that can compromise patient safety and assistance during intensive care unit (ICU) hospitalizations. This trial will be conducted in five general intensive care unit. One hundred and twenty patients will be enrolled in this study divided into three equal groups (40 patients in each group). Group A is the control group. Group B is music group. Group C is essential oil group. Agitated mechanically ventilated patients will be randomly assigned to one of the three groups. Each group will be subjected to its specific intervention and they will be monitored for seven days. Agitation score and frequency outcome will be assessed at the end of the study.

Official Title
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The Effect of Music and Essential Oil on Agitation in Mechanically Ventilated Patients

Conditions
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Agitation

Intervention / Treatment
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* Other: Music
* Other: Essential oil
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Agitation with RASS score +2 or more Mechanical ventilation Patients with GCS 13-15 Exclusion Criteria: Psychiatric illness Cognitive disorders Neurological disorder Hearing deficit Smelling deficit Respiratory asthma Allergic rhinitis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three-group pre-test and repeated post-test study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Mechanically ventilated patients who will be subjected to the routine unit intervention for agitation | Other: Control<br>* The routine intensive care unit sedation protocol<br>|
| Experimental: Music group<br>Mechanically ventilated patients who will listen to classic music | Other: Music<br>* Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property<br>|
| Experimental: Essential oil group<br>Mechanically ventilated patients who will inhale bergamot oil | Other: Essential oil<br>* Bergamot oil inhalation through a piece of cotton gauze (2 × 2 cm square shape) with 0.5 cc of bergamot oil. It will be attached to the collar of the patient's clothes gown, approximately 15 cm below their nose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agitation score | Agitation score is assessed by Richmond Agitation-Sedation Scale (RASS). The RASS is a 10-point scale ranging from -5 to +4. Levels from -1 to -5 denote increasing levels of sedation. Levels from +1 to +4 describe increasing levels of agitation. Zero score is the best response for the patient which is considered normal. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation, Music therapy, Essential oil, Bergamot oil