Investigating the effect of lavender (Lavandula angustifolia) inhalation aroma therapy on stress, anxiety and depression of addicts under treatment hospitalized in the addiction wards
Determining the effect of lavender inhalation aromatherapy on stress, anxiety, and depression in addicts undergoing drug treatment
Design
A randomized, controlled clinical trial with parallel groups on 56 addicts. Random allocation software is used for randomization.
Settings and conduct
Addicts hospitalized in the addiction wards of Modares Hospital in Isfahan will be enrolled in the study on a convenience basis and then randomly assigned to two experimental and control groups. Inhaled aromatherapy will be administered to the intervention group. Blinding will not be performed in this study.
Participants/Inclusion and exclusion criteria
Entry requirements:
1. Age 18 years and above
2. Be able to read and write in Persian.
3. Consent to participate in the study.
4. Not be participating in another similar study at the same time as the research.
5. Be under methadone maintenance treatment.
Exclusion criteria:
1. History of allergic rhinitis, eczema or known respiratory problems such as asthma
2. Having a cold or any other condition that affects the person's ability to smell.
3. History of lavender allergy (skin or inhalation) as self-reported and tested
Intervention groups
For the intervention group, in addition to receiving drug treatment and routine care, aromatherapy with lavender will be performed. In the intervention group, the samples participating in the study will undergo aromatherapy with lavender essential oil for 3 days at 10 am and 6 pm. Thus, the researcher drops 2 drops of 100% pure lavender essential oil with a dropper onto a 10 x 10 gauze and attaches it to the research subject's collar 20 cm from the nose with a clip. After that, the patient is asked to breathe normally for 20 minutes; their stress, anxiety, and depression levels are measured immediately before and after the end of the intervention.
Main outcome variables
Stress, anxiety, depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141127020108N9
Registration date:2025-06-12, 1404/03/22
Registration timing:prospective
Last update:2025-06-12, 1404/03/22
Update count:0
Registration date
2025-06-12, 1404/03/22
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 2856
Email address
musarezaie@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-11, 1404/04/20
Expected recruitment end date
2026-03-20, 1404/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of lavender (Lavandula angustifolia) inhalation aroma therapy on stress, anxiety and depression of addicts under treatment hospitalized in the addiction wards
Public title
Investigating the effect of lavender (Lavandula angustifolia) inhalation aroma therapy on stress, anxiety and depression of addicts
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and above
be able to read and write in Persian.
Consent to participate in the study.
Exclusion criteria:
Having a history of allergic rhinitis, eczema, or known respiratory problems such as asthma
Having a cold or anything else that affects a person's ability to smell.
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with size of 4. Randomization unit: individual. Randomization tool: Random allocation software. Random chain concealment is by placing participants' codes in opaque envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan
Street address
sfahan University of Medical Sciences, Hezar Jarib St, Isfahan, Isfahan Province, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2025-03-10, 1403/12/20
Ethics committee reference number
IR.MUI.NUREMA.REC.1403.185
Health conditions studied
1
Description of health condition studied
Drug addiction
ICD-10 code
Z63.72
ICD-10 code description
Alcoholism and drug addiction in family
Primary outcomes
1
Description
stress
Timepoint
Immediately before and three days after the start of the intervention
Intervention group: In the Intervention group, the samples participating in the study were subjected to aromatherapy with lavender essential oil for 3 days at 10 am and 6 pm. Thus, the researcher drops 2 drops of lavender essential oil (product of Barij Essential Oil Company, Kashan) with a dropper on a sterile cloth measuring 10 cm by 10 cm and attaches it to the collar of the research unit's clothing with a clip at a distance of 20 cm from the nose. Immediately before and after the end of the intervention, their stress, anxiety, and depression levels are measured using a questionnaire.
Category
N/A
2
Description
Control group: The control group will be hospitalized in the ward, receive routine treatments and care, and like the intervention group, their levels of stress, anxiety, and depression will be assessed using questionnaires immediately before the study and three days after the start of the study.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modares Hospital
Full name of responsible person
Shahid Modares Hospital
Street address
18 km of Isfahan-Najaf Abad road
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Building number 4, Isfahan University of Medical Sciences, Hezar Jarib St, Isfahan, Isfahan Province, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.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
Amir Musarezaie
Position
Nursing faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musarezaie
Position
Nursing faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Musarezaie
Position
Nursing faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hazar Jarib Street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
musarezaie@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available