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NCT Number: NCT04722614

Music and Essential Oil in Agitation

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.

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Key information

Conditions

Agitation Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Dyskinesias Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Main University Hospital, Alexandria, Egypt

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About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property

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

Primary outcomes

  1. Agitation score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 25, 2021
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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