AnxietyNCT07305493
Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Treatment for Pain
A study testing Lavender Extract Aromatherapy in people with Anxiety and Pain, run by Universitas Islam Indonesia at 1 site in Indonesia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anxiety, Pain, Aromatherapy
- What is being tested?
- Lavender Extract Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2022to 29 May 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Anxiety, Pain, Aromatherapy
- Being tested
- Lavender Extract Aromatherapy, Placebo
- Keywords
- Aromatherapy, Lavandula, Anxiety, Anxiety Disorder, Pain, Mind-Body Therapies
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender Extract AromatherapyCombination product
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
PlaceboOther
This intervention will be just an exposure of diffused water (H2O) for 30 minutes as a control to experimental group
| Study group | Role | What they receive |
|---|---|---|
| Lavender Aromatherapy Group | Experimental | This group will be consist of 34 participants that already randomized. This group will be exposed to lavender aromatherapy Receives: Combination Product: Lavender Extract Aromatherapy |
| Control Group | Placebo comparator | This control will be exposed to water diffused gas as a control to experimental group Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Score
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
Measured: Before exposure and 15 minutes after exposure has done
Secondary outcomes (1)
Pain Scale
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
Measured: Before exposure and 15 minutes after exposure has done
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Oct 2022
- Primary completion31 Mar 2023
- Study completion29 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be plotted into two groups, consist of experimental group and controls group, participation allocation will be randomized
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Islam Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angga Ardhan Derryawan, MD, Universitas Islam Indonesia
- Investigators
- Angga A Derryawan, MD, Principal investigator, Universitas Islam Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305493
- Sponsor's protocol ID
- 9/Ka.Kom.Et/70/KE/I/2023
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Toward Pain
- ClinicalTrials.gov ID
- NCT07305493
- Acronym / sponsor ID
- 9/Ka.Kom.Et/70/KE/I/2023
- Conditions
- Anxiety, Pain, Aromatherapy
- Keywords
- Aromatherapy, Lavandula, Anxiety, Anxiety Disorder, Pain, Mind-Body Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universitas Islam IndonesiaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 26 Dec 2025 (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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study will be plotted into two groups, consist of experimental group and controls group, participation allocation will be randomized
| Arm | Type | Receives |
|---|---|---|
| Lavender Aromatherapy Group | Experimental | Combination Product: Lavender Extract AromatherapyThis group will be consist of 34 participants that already randomized. This group will be exposed to lavender aromatherapy |
| Control Group | Placebo comparator | Other: PlaceboThis control will be exposed to water diffused gas as a control to experimental group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Lavender Extract AromatherapyThis 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 | Combination product | Lavender Aromatherapy Group |
| PlaceboThis intervention will be just an exposure of diffused water (H2O) for 30 minutes as a control to experimental group | Other | Control Group |
Primary outcome
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
1 secondary outcome
Pain Scale
Time frame: Before exposure and 15 minutes after exposure has done
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 2 Jan 2026.
- Individual participant dataSharing planned: Yes. 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
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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.
Angga A Derryawan, MD principal investigator
Universitas Islam Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Extract Aromatherapy in people with Anxiety and Pain, run by Universitas Islam Indonesia at 1 site in Indonesia.
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 4 inclusion and 4 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 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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. Some participants in this study may receive a placebo. 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?
Anxiety Score (time frame: Before exposure and 15 minutes after exposure has done). 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 2 Jan 2026.