Music and Essential Oil in Agitation

July 22, 2022 updated by: Alexandria University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21500
        • Alexandria Main University Hospital
      • Alexandria, Egypt, 21548
        • Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Mechanically ventilated patients who will be subjected to the routine unit intervention for agitation
Other: Control
The routine intensive care unit sedation protocol
Experimental: Music group
Mechanically ventilated patients who will listen to classic music
Other: Music
Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property
Experimental: Essential oil group
Mechanically ventilated patients who will inhale bergamot oil
Other: Essential 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: E A Hassan, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2021

Primary Completion (Actual)

June 22, 2021

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

July 25, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1112021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Researchers are waiting to get approval from research committee to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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