Music and Essential Oil in Agitation
Primary Purpose
Agitation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Music
Essential oil
Control
Sponsored by
About this trial
This is an interventional prevention trial for Agitation focused on measuring Mechanical ventilation, Music therapy, Essential oil, Bergamot oil
Eligibility Criteria
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
Sites / Locations
- Alexandria Main University Hospital
- Faculty of nursing
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control group
Music group
Essential oil group
Arm Description
Mechanically ventilated patients who will be subjected to the routine unit intervention for agitation
Mechanically ventilated patients who will listen to classic music
Mechanically ventilated patients who will inhale bergamot oil
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04722614
Brief Title
Music and Essential Oil in Agitation
Official Title
The Effect of Music and Essential Oil on Agitation in Mechanically Ventilated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2021 (Actual)
Primary Completion Date
June 22, 2021 (Actual)
Study Completion Date
July 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation
Keywords
Mechanical ventilation, Music therapy, Essential oil, Bergamot oil
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three-group pre-test and repeated post-test study
Masking
Care Provider
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.
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Mechanically ventilated patients who will be subjected to the routine unit intervention for agitation
Arm Title
Music group
Arm Type
Experimental
Arm Description
Mechanically ventilated patients who will listen to classic music
Arm Title
Essential oil group
Arm Type
Experimental
Arm Description
Mechanically ventilated patients who will inhale bergamot oil
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property
Intervention Type
Other
Intervention Name(s)
Essential oil
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
The routine intensive care unit sedation protocol
Primary Outcome Measure Information:
Title
Agitation score
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E A Hassan
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria Main University Hospital
City
Alexandria
ZIP/Postal Code
21500
Country
Egypt
Facility Name
Faculty of nursing
City
Alexandria
ZIP/Postal Code
21548
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Researchers are waiting to get approval from research committee to make individual participant data (IPD) available to other researchers
Learn more about this trial
Music and Essential Oil in Agitation
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