Agitation
Conditions
Keywords
Mechanical ventilation, Music therapy, Essential oil, Bergamot oil
Brief 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.
Interventions
OTHERMusic
Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property
OTHEREssential 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.
OTHERControl
The routine intensive care unit sedation protocol
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Masking description
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.
Intervention model description
Three-group pre-test and repeated post-test study
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agitation score | 7 days | 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. |
Countries
Egypt
Outcome results
None listed