Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Treatment for Pain
December 27, 2025 updated by: Angga Ardhan Derryawan, MD, Universitas Islam Indonesia
The Use of Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Toward Pain
This clinical trial will assess whether aromatherapy inhalation (especially lavender extract essential oil) can be used as a complementary therapy for anxiety and pain.
In this study, outcomes will be measured using the Numeric Rating Scale (NRS) for pain score and State-Trait Anxiety Inventory (STAI) questionnaire to assess state and trait anxiety scores.
The two questionnaires above will be used to determine pre-post pain and anxiety scores after exposure.
This study's primary research question is "Does linalool in lavender extract essential oil aromatherapy reduce anxiety in patients with pain complaints ?".
With the question above, it is hypothesized that linalool can be an anti-anxiety towards pain.
The product of aromatherapy will be tested in a GC-MS assay for every substance inside and proving linalool as a key substance.
To prove the effect of linalool, this study will compare diffused lavender extract essential oil aromatherapy with a placebo to determine its effect as an anxiety reliever.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective in this clinical trial is to evaluate the effect of linalool in lavender extract essential oil aromatherapy as anti-anxiety treatment for pain. The linalool inside lavender extract will be proven with GC-MS assay first. Then, after linalool has been confirmed as a key substance inside the extract, the lavender extract essential oil will be mixed with water to dilute it before it is exposed to participants in the experimental group. This study will assess anxiety and pain scale using the Numeric Rating Scale (NRS) for pain score and the State-Trait Anxiety Inventory (STAI) before exposure and 15 minutes after the exposure has been done. This complementary therapy can be an innovation in addition to conventional pain therapy, with the theory that anxiety towards pain can amplify the pain, and GABA-ergic activity in the brain can help inhibit the pain.
Study design: This study is using a Randomized Controlled Trials (RCT) with pre and post test assessment. This study will be blinding the participants and care provider.
Allocation:
- Participant will be allocated using simple randomization to the experimental or placebo group
- All the participants who agreed to the informed consent will be included and randomized to the experimental or placebo group
- Then every participant will be exposed to the intervention as scheduled personally
Group/Arm:
- Experimental Group (Lavender Aromatherapy group)
- Placebo Control Group
Intervention:
- The experimental group will use Young Living Lavender Extract Essential Oil to be diffused and exposed to participants as inhalation therapy in the experimental group. It consists 2 mL of lavender essential oil diluted in 40 mL of water (H2O). It will be exposed to participants for 30 minutes
- Placebo / Control group will be exposed to diffused water (H2O) for 30 minutes
Data Analysis Plan: The data will be analyzed using univariate analysis and bivariate analysis (Independent T-Test, Paired T-Test, Wilcoxon Test, ANOVA, and/or Mann-Whitney test)
Anticipated outcome:
- Reduction in anxiety score
- Reduction in pain score
- Low risk of allergies
- No adverse event
Risks:
- Allergies
- Adverse event
Benefits:
- Innovation in addition to pain conventional therapy as a complementary therapy
- Widely accessible
- Prices vary
- Enhances treatment and prevents reduced function or reduced quality of life
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
D.I.Yogyakarta
-
Yogyakarta, D.I.Yogyakarta, Indonesia, 55244
- Ludira Husada Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient that complains about pain (acute or chronic) that do not have any allergic history of lavender
- Patient doesnt have any abnormalities / disease in olfactory/respiratory
- Pain are classified as moderate to severe pain (higher than 4 points in NRS)
- Patient is not in pregnant conditions
Exclusion Criteria:
- Exposure are not completed for 30 minutes due to any cause
- Consuming any pain relieving drug (such as NSAID) 1 hour before exposure or in the middle between pre and post-test period
- Any adverse event that associated to exposure or did not associated to exposure
- There is or appears to be an allergy to lavender aromatherapy ingredients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lavender Aromatherapy Group
This group will be consist of 34 participants that already randomized.
This group will be exposed to lavender aromatherapy
|
This group will be exposed to diffused Lavender Extract Essential Oil Aromatherapy.
Aromatherapy given to this group will be linalool concentrate (verificated with GC-MS of the essential oil) in forms of 2 mL Lavender Essential Oil from Young Living diluted in 40 mL water for 30 minutes
|
|
Placebo Comparator: Control Group
This control will be exposed to water diffused gas as a control to experimental group
|
This intervention will be just an exposure of diffused water (H2O) for 30 minutes as a control to experimental group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Score
Time Frame: Before exposure and 15 minutes after exposure has done
|
This parameter measured using State Trait Anxiety Inventory (STAI) Questionnaire.
This questionnaire can be used to assess state and trait anxiety.
It is consist of 2 segment, state segment for current anxiety scale and trait segment for any consistent anxiety feeling scale.
This questionnaire have score range between 20 (minimum) and 80 (maximum).
It is classified as mild anxiety for 20-39 points, moderate anxiety for 40-59 points, and severe anxiety for 60-80 points.
This questionnaire has been tested for its validity by McDowell in 2006 with interval value 0,88.
For its reliability, it has been tested by McDowell too in 2006 with alpha for S part 0,93 and T part 0,91
|
Before exposure and 15 minutes after exposure has done
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Scale
Time Frame: Before exposure and 15 minutes after exposure has done
|
This parameter measured with NRS questionnaire for assessing pre-post exposure pain scale changes.
This questionnaire will have score range between 0-10 points.
0 point stands for no pain, 1-3 points will stands for mild pain, 4-6 for moderate pain, and 7-10 stands for severe pain
|
Before exposure and 15 minutes after exposure has done
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Angga A Derryawan, MD, Universitas Islam Indonesia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2022
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
May 29, 2023
Study Registration Dates
First Submitted
December 12, 2025
First Submitted That Met QC Criteria
December 12, 2025
First Posted (Estimated)
December 26, 2025
Study Record Updates
Last Update Posted (Estimated)
January 2, 2026
Last Update Submitted That Met QC Criteria
December 27, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9/Ka.Kom.Et/70/KE/I/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data that will be shared will be raw data of anxiety and pain score.
If requested, participant demographic data will be shared in limited information due to privacy
IPD Sharing Time Frame
Supporting information will be available until end of December 2027 (4 years after the study has completed)
IPD Sharing Access Criteria
Anyone who studying / researching and needed raw data can contact this study principal investigator to access this study raw data
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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