Clinical Trials Directory

Trials / Completed

CompletedNCT04722614

Music and Essential Oil in Agitation

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
123 (actual)
Sponsor
Alexandria University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERMusicClassic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property
OTHEREssential oilBergamot 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.
OTHERControlThe routine intensive care unit sedation protocol

Timeline

Start date
2021-04-11
Primary completion
2021-06-22
Completion
2022-07-20
First posted
2021-01-25
Last updated
2022-07-25

Locations

2 sites across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04722614. Inclusion in this directory is not an endorsement.