Music and Essential Oil in Agitation

Alexandria University

Status: Completed

Conditions: Agitation

Treatments: Other: Essential oil; Other: Music; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04722614

1112021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 123 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 3 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Other: Control

Music group

Experimental group

Description:

Mechanically ventilated patients who will listen to classic music

Treatment:

Other: Music

Essential oil group

Experimental group

Description:

Mechanically ventilated patients who will inhale bergamot oil

Treatment:

Other: Essential oil