AgitationNCT04722614
Music and Essential Oil in Agitation
A study testing Music and Essential oil in people with Agitation, run by Alexandria University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Agitation
- What is being tested?
- Music and Essential oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 2 sitesEgypt
- Study dates
- 11 Apr 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Agitation with RASS score +2 or more
- Mechanical ventilation
- Patients with GCS 13-15
Who cannot join
- Psychiatric illness
- Cognitive disorders
- Neurological disorder
- Hearing deficit
- Smelling deficit
- Respiratory asthma
- Allergic rhinitis
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Alexandria Main University Hospital
Alexandria, 21500
Faculty of nursing
Alexandria, 21548
About this study
Official title: 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.
Read the 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.
- Conditions
- Agitation
- Being tested
- Music, Essential oil, Control
- Keywords
- Mechanical ventilation, Music therapy, Essential oil, Bergamot oil
- Medical subject headings
- Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property
Essential oilOther
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.
ControlOther
The routine intensive care unit sedation protocol
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Mechanically ventilated patients who will be subjected to the routine unit intervention for agitation Receives: Other: Control |
| Music group | Experimental | Mechanically ventilated patients who will listen to classic music Receives: Other: Music |
| Essential oil group | Experimental | Mechanically ventilated patients who will inhale bergamot oil Receives: Other: Essential oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start11 Apr 2021
- Primary completion22 Jun 2021
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-group pre-test and repeated post-test study
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E A Hassan, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722614
- Sponsor's protocol ID
- 1112021
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Researchers are waiting to get approval from research committee to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music and Essential Oil on Agitation in Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT04722614
- Acronym / sponsor ID
- 1112021
- Conditions
- Agitation
- Keywords
- Mechanical ventilation, Music therapy, Essential oil, Bergamot oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 11 Apr 2021 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- Three-group pre-test and repeated post-test study
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: ControlMechanically ventilated patients who will be subjected to the routine unit intervention for agitation |
| Music group | Experimental | Other: MusicMechanically ventilated patients who will listen to classic music |
| Essential oil group | Experimental | Other: Essential oilMechanically ventilated patients who will inhale bergamot oil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Agitation with RASS score +2 or more
- Mechanical ventilation
- Patients with GCS 13-15
Key exclusion criteria (7 listed)
- Psychiatric illness
- Cognitive disorders
- Neurological disorder
- Hearing deficit
- Smelling deficit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicClassic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property | Other | Music group |
| Essential oilBergamot 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. | Other | Essential oil group |
| ControlThe routine intensive care unit sedation protocol | Other | Control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: No. Researchers are waiting to get approval from research committee to make individual participant data (IPD) available to other researchers
Related trials for Agitation
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 2/3
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Agitation Associated With Alzheimer's Disease Dementia
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E A Hassan principal investigator
Alexandria University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Essential oil in people with Agitation, run by Alexandria University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agitation score (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.