Music and Essential Oil in Agitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-11

Study Completion Date

2022-07-20

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.

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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.

Conditions

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Agitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three-group pre-test and repeated post-test study

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Computer generated randomization (www.randomizer.org) will be used to randomly assign patients to groups. Information of allocation was available to the principal researcher only. Patients will be assigned in sequential numbers that will be placed in an opaque, sealed envelope by the researcher. After patients enrollment, the envelope will be opened. The nurses could not be blinded to the allocation because of the nature of the intervention. However, the outcome assessment of the patients was blinded.

Study Groups

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Control group

Mechanically ventilated patients who will be subjected to the routine unit intervention for agitation

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

The routine intensive care unit sedation protocol

Music group

Mechanically ventilated patients who will listen to classic music

Group Type EXPERIMENTAL

Music

Intervention Type OTHER

Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property

Essential oil group

Mechanically ventilated patients who will inhale bergamot oil

Group Type EXPERIMENTAL

Essential oil

Intervention Type OTHER

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.

Interventions

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Music

Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property

Intervention Type OTHER

Essential oil

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.

Intervention Type OTHER