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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Mechanically ventilated patients who will be subjected to the routine unit intervention for agitation |
|
| Music group | Experimental | Mechanically ventilated patients who will listen to classic music |
|
| Essential oil group | Experimental | Mechanically ventilated patients who will inhale bergamot oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music | Other | Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E A Hassan | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria Main University Hospital | Alexandria | 21500 | Egypt | |||
| Faculty of nursing |
Researchers are waiting to get approval from research committee to make individual participant data (IPD) available to other researchers
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| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| D009822 | Oils, Volatile |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Three-group pre-test and repeated post-test study
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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.
| Essential oil | Other | 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 | Other | The routine intensive care unit sedation protocol |
|
| Alexandria |
| 21548 |
| Egypt |
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009821 | Oils |
| D008055 | Lipids |