Music and Essential Oil in Agitation

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT04722614

Collaborator

(none)

123

Enrollment

Locations

Arms

15.3

Actual Duration (Months)

61.5

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Agitation	Other: Music Other: Essential oil Other: Control	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Three-group pre-test and repeated post-test studyThree-group pre-test and repeated post-test study

Masking:

Single (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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 11, 2021

Actual Primary Completion Date :

Jun 22, 2021

Actual Study Completion Date :

Jul 20, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Main University Hospital	Alexandria		Egypt	21500
2	Faculty of nursing	Alexandria		Egypt	21548

Sponsors and Collaborators

Alexandria University

Investigators

Principal Investigator: E A Hassan, Alexandria University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexandria University

ClinicalTrials.gov Identifier:

NCT04722614

Other Study ID Numbers:

1112021

First Posted:

Jan 25, 2021

Last Update Posted:

Jul 25, 2022

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alexandria University

Mechanical ventilation

Music therapy

Essential oil

Bergamot oil

Additional relevant MeSH terms:

Psychomotor Agitation

Study Results

No Results Posted as of Jul 25, 2022