Effectiveness of Aromatherapy with Lavender Essential Oil Compared to Rosa Damascena on Reducing Delirium and Improving Clinical Outcomes in Multiple Trauma Patients in the Intensive Care Unit
To determine the effectiveness of inhalation aromatherapy with lavender essential oil compared to rose essential oil on reducing delirium and improving clinical outcomes in multiple trauma patients.
Design
Randomized clinical trial, placebo controlled, with parallel groups, double blind on 123 patients.
Settings and conduct
The study is conducted in the intensive care unit of Payambar e Azam educational and medical center in Bandar Abbas. Random allocation is concealed using opaque envelopes. Patients and outcome assessors are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Trauma patients aged 18 to 65 years; Injury Severity Score less than 15; Glasgow Coma Scale greater than 8; lack of sensitivity to herbal essential oils. Exclusion criteria: Baseline delirium; history of psychiatric disorders; olfactory disorders.
Intervention groups
The first group receives lavender essential oil, the second group receives rose essential oil, and the control group receives distilled water via inhalation with completely identical containers and conditions.
Main outcome variables
Incidence of delirium; severity of delirium; level of consciousness and agitation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240929063203N7
Registration date:2026-05-28, 1405/03/07
Registration timing:prospective
Last update:2026-05-28, 1405/03/07
Update count:0
Registration date
2026-05-28, 1405/03/07
Registrant information
Name
Milad Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 76 9999 4691
Email address
miladmohammadi981@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-31, 1405/03/10
Expected recruitment end date
2027-05-31, 1406/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Aromatherapy with Lavender Essential Oil Compared to Rosa Damascena on Reducing Delirium and Improving Clinical Outcomes in Multiple Trauma Patients in the Intensive Care Unit
Public title
Effectiveness of Aromatherapy with Lavender Essential Oil Compared to Rosa Damascena on Reducing Delirium and Improving Clinical Outcomes in Multiple Trauma Patients in the Intensive Care Unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 18 and 65 years
Injury Severity Score (ISS) less than 15
Glasgow Coma Scale (GCS) score greater than 8
No known allergy or sensitivity to essential oils
Providing informed consent to participate in the study
Exclusion criteria:
Presence of baseline delirium at admission
History of psychiatric disorders
Presence of olfactory disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
123
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial, individual randomization is performed using block randomization with block sizes of 3, 6, and 9. Multiple trauma patients admitted to the intensive care unit of Payambar-e-Azam Educational and Medical Center who meet the inclusion criteria are randomly and equally assigned to three groups: two intervention groups (receiving lavender essential oil and rose essential oil) and a control group (receiving distilled water).
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind clinical trial. In this investigation, patients (participants) and the nurses responsible for administering the intervention, outcome assessment, and clinical care will be completely blinded to the group allocation and the type of scent received. To maintain blinding, the intervention is carried out under the supervision of a blinded nurse, and patients in the control group will receive distilled water (as a placebo) with an identical appearance and inhalation method to the intervention groups (lavender and rose essential oils) so that no difference is perceived in the procedure. This design minimizes the risk of performance bias and detection bias.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Hormozgan University of Medical Sciences
Street address
Shahid Chamran Boulevard, University of Medical Sciences and Health Services, Bandar Abbas.
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2026-01-27, 1404/11/07
Ethics committee reference number
IR.HUMS.REC.1404.346
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
2
Description of health condition studied
Multiple trauma
ICD-10 code
M12.59
ICD-10 code description
Traumatic arthropathy, multiple sites
Primary outcomes
1
Description
Incidence of delirium in admitted patients.
Timepoint
Daily from the beginning of the study for 5 days (or until discharge from the intensive care unit if discharged earlier).
Method of measurement
Clinical assessment/0-7 points
2
Description
Mean score of delirium severity.
Timepoint
Daily from the start of the intervention for 5 days (or until discharge from the intensive care unit).
Method of measurement
Clinical assessment/0-8 points
3
Description
Patient’s level of consciousness, sedation, and agitation.
Timepoint
Daily from the beginning of the intervention for 5 days (or until discharge from the intensive care unit).
Method of measurement
Richmond Agitation-Sedation Scale.
Secondary outcomes
1
Description
Length of stay in the intensive care unit
Timepoint
From the time of admission until discharge from the intensive care unit
Method of measurement
Recording the number of hospitalization days based on the clinical records
2
Description
Length of hospital stay
Timepoint
From admission to final discharge from the hospital
Method of measurement
Recording the total number of hospitalization days by reviewing the medical records
3
Description
Duration of mechanical ventilation
Timepoint
From intubation to successful extubation (weaning from the ventilator)
Method of measurement
Calculating the days and hours on mechanical ventilation recorded in nursing reports
4
Description
Consumption of sedative and antipsychotic medications
Timepoint
Daily during the intervention period (up to 5 days) or until discharge from the intensive care unit
Method of measurement
Recording the total dose and type of received medications by reviewing physician orders and pharmacological records
5
Description
Pain intensity
Timepoint
Daily assessment for 5 days or until discharge from the intensive care unit
Method of measurement
Using standard pain assessment tools (e.g., behavioral pain scales for unconscious patients or Visual Analogue Scale)
6
Description
Mortality rate
Timepoint
During the hospitalization period
Method of measurement
Recording the patient’s survival or death status in the medical records
Intervention groups
1
Description
Intervention group: After randomization, patients in the first intervention group receive aromatherapy with pure lavender essential oil in addition to standard ICU care. The essential oil is certified for purity and quality and has a minimum purity of 98%. A sterile 4×44×4 gauze pad is impregnated with 5 drops of lavender essential oil and placed approximately 10 cm from the patient’s nose (attached to the patient’s collar). Patients are instructed to inhale the aroma for 30 minutes. The intervention is performed once daily between 8–9 AM for five consecutive days or until ICU discharge, whichever occurs first.
Category
Treatment - Other
2
Description
Intervention group: Patients in the second intervention group receive aromatherapy with pure Rosa damascena (rose) essential oil in addition to standard care. The administration protocol is identical to the lavender group. A sterile 4×44×4 gauze pad impregnated with 5 drops of rose essential oil is placed approximately 10 cm from the patient’s nose, and the patient inhales the aroma for 30 minutes. The intervention is administered once daily between 8–9 AM for five consecutive days or until ICU discharge.
Category
Treatment - Other
3
Description
Control group: Patients in the control group receive standard ICU care only and no aromatherapy intervention. To maintain blinding, a similar container with distilled water is placed near the patient’s pillow to mimic the intervention conditions.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The Great Prophet's (PBUH) educational, therapeutic and research center
Full name of responsible person
Pejman Shahrokhi
Street address
Shahid Mohammadi Hospital, Islamic Republic Blvd., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Fax
+98 76 3333 3280
Email
miladmohammadi981@gmail.com
Web page address
https://shmh.hums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Shahram Zare
Street address
Shahid Mohammadi Hospital, Islamic Republic Blvd., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 917 161 3924
Fax
+98 76 3333 3280
Email
miladmohammadi981@gmail.com
Web page address
https://hums.ac.ir/
Grant name
Grant code / Reference number
4040438
Is the source of funding the same sponsor organization/entity?