Music and Essential Oil in Agitation

Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722614
• Other study ID #: 1112021
• Status: Completed
• Phase: N/A
• Start date: April 11, 2021
• Est. completion date: July 20, 2022

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: July 20, 2022
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Agitation
• Psychomotor Agitation

Intervention

Other:
• Music
Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property
• 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.
• Control
The routine intensive care unit sedation protocol

Locations

Country	Name	City	State
Egypt	Alexandria Main University Hospital	Alexandria
Egypt	Faculty of nursing	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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