Music and Essential Oil in Agitation

NCT04722614 | Completed DMC

• 1 other identifier: 1112021
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

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.

Conditions

Agitation

Keywords

Mechanical ventilation; Music therapy; Essential oil; Bergamot oil

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Control group

ACTIVE COMPARATOR

Mechanically ventilated patients who will be subjected to the routine unit intervention for agitation

Other: Control

Music group

EXPERIMENTAL

Mechanically ventilated patients who will listen to classic music

Other: Music

Essential oil group

EXPERIMENTAL

Mechanically ventilated patients who will inhale bergamot oil

Other: Essential oil

Interventions

Music OTHER

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

Music group

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.

Essential oil group

Control OTHER

The routine intensive care unit sedation protocol

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Agitation with RASS score +2 or more
• Mechanical ventilation
• Patients with GCS 13-15

You may not qualify if:

• Psychiatric illness
• Cognitive disorders
• Neurological disorder
• Hearing deficit
• Smelling deficit
• Respiratory asthma
• Allergic rhinitis

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Alexandria Main University Hospital

Alexandria, 21500, Egypt

Location

Faculty of nursing

Alexandria, 21548, Egypt

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Music Therapy; Oils, Volatile

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Oils; Lipids

Study Officials

• E A Hassan

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three-group pre-test and repeated post-test study

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: April 11, 2021
• Primary Completion: June 22, 2021
• Study Completion: July 20, 2022
• Last Updated: July 25, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)