Protocol summary

Study aim
Determining the effect of lavender aromatherapy on emotional disturbance in patients referred to the psychiatric emergency department
Design
An experimental study, with a control group and parallel groups on 70 patients.
Settings and conduct
The research setting is the psychiatric emergency department of Farabi Hospital in Isfahan. Study samples are patients who have been referred to the emergency department for mood disorders, schizophrenia, anxiety disorders, or relapse of their illness.Patients in the test group will undergo aromatherapy with lavender essential oil from the Geya Kala Company, which has health license number 31/10193. Patients will receive lavender aroma upon arrival to the emergency room and within the first 20 minutes of the patient's arrival in the emergency room using a fogger. The same applies to the control group, except that distilled water will be used as a placebo instead of lavender aroma.
Participants/Inclusion and exclusion criteria
Patients referred to the emergency department of Farabi Hospital for men and women with mood disorders (depression and bipolar disorder), schizophrenia, anxiety disorders, or relapse of their illness. The patient's partner consented to their patient's participation in the study. The patient had a normal sense of smell according to the partner's statements. The patient had no history of any respiratory allergies. The patient had no cold. Exclusion criteria: History of any allergies.
Intervention groups
Intervention group: Patients in the test group will undergo aromatherapy with lavender essential oil. Patients will receive lavender aroma upon arrival to the emergency room and within the first 20 minutes of the patient's arrival in the emergency room using a misting device. Control group: Patients in the control group are exposed to distilled water instead of lavender.
Main outcome variables
Emotional disturbance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101213005385N3
Registration date: 2025-05-05, 1404/02/15
Registration timing: prospective

Last update: 2025-05-05, 1404/02/15
Update count: 0
Registration date
2025-05-05, 1404/02/15
Registrant information
Name
Mohammad Akbari kaji
Name of organization / entity
Medical university of isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1867 3632
Email address
akbari129@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-10, 1404/02/20
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The Effect of Aromatherapy with Lavender Scent on The Emotional Disturbance of Patients Referred to The Psychiatric Emergency Room
Public title
Investigating The Effect of Aromatherapy with Lavender Scent on The Emotional Disturbance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient is referred to the Men's and Women's Psychiatric Emergency Department at Farabi Hospital. The patient has visited the emergency room due to mood disorders (depression and bipolar disorder), schizophrenia, anxiety disorders, or a relapse of their illness. The patient's companion must consent to their patient's participation in the research. According to the patient's companion, the patient has a normal sense of smell. The patient should not have a history of any respiratory allergies. The patient does not have a cold.
Exclusion criteria:
The patient may develop an allergy during the intervention.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected based on the inclusion criteria. This study will be conducted with the participation of 70 patients referred to the male and female psychiatric emergency department of Farabi Hospital, Isfahan in 1404.The selection of the control and experimental groups will be random. Patients in the experimental group will undergo aromatherapy with lavender essential oil prepared from the Gea Kala Company, which has health license number 31/10193.The nurses will receive the lavender scent upon arrival at the emergency room and within the first 20 minutes of the patient's arrival at the emergency room using a nebulizer. The control group will be treated similarly, except that distilled water will be used as a placebo instead of the lavender scent.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Comittee in Research Faculty of Nursing, Management and Rehabilitation-Isfahan University
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2025-04-23, 1404/02/03
Ethics committee reference number
IR.MUI.NUREMA.REC.1404.011

Health conditions studied

1

Description of health condition studied
Anxiety disorders
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders

2

Description of health condition studied
Mood disorders
ICD-10 code
F30
ICD-10 code description
Manic episode

3

Description of health condition studied
Mood disorders
ICD-10 code
F31
ICD-10 code description
Bipolar disorder

4

Description of health condition studied
Anxiety disorders
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

5

Description of health condition studied
Mood disorders
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
The Emotional Disturbance of Patients Referred to The Psychiatric Emergency Room
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Researcher-made Emotional Disturbance checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in the test group will undergo aromatherapy with lavender essential oil from the Geya Kala Company, which has health license number 31/10193. Patients will receive lavender aroma upon arrival to the emergency room and within the first 20 minutes of the patient's arrival in the emergency room using a misting device.
Category
Other

2

Description
Control group: Patients in the control group receive no specific intervention and are exposed to distilled water instead of lavender.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Mahdi Jokar
Street address
Farabi Specialized and Subspecialized Hospital, Arghawaniye Blvd, Mushtaq 3rd St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8155113153
Phone
+98 31 3531 2000
Email
farabi@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Asgari
Street address
Nursing and Midwifery Faculty, Esfahan University of Medical Sciences, Hezarjerib Ave
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Akbari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery Faculty, Esfahan University of Medical Sciences, Hezarjerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7502
Email
mohammadakbari@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Akbari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery Faculty, Esfahan University of Medical Sciences, Hezarjerib Ave
City
Esfahan
Province
Isfehan
Postal code
9174673461
Phone
+98 31 3792 7502
Email
mohammadakbari@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Akbari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery Faculty, Esfahan University of Medical Sciences, Hezarjerib Ave
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7502
Email
mohammadakbari@nm.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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