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The Use of Lavender (Lavandula Angustifolia) Aromatherapy Inhalation As An Anti-Anxiety Towards Pain

NCT ID: NCT07305493

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-05-29

Brief Summary

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This clinical trial will assess the effect of aromatherapy inhalation (especially lavender extract essential oil) can be used as complementary therapy for anxiety toward pain. In this study, outcome will be measured using Numeric Rating Scale (NRS) for pain score and State-Trait Anxiety Inventory (STAI) questionnaire to assess state and trait anxiety score. Two questionnaire above will be used to assess pre-post pain and anxiety score after exposure. This study primary research questions "Does linalool in lavender extract essential oil aromatherapy can reduce anxiety in patients with pain complaint ?". With the question above, it is hipothesized that linalool can be an anti-anxiety towards pain. The product of aromatherapy will be tested in GC-MS assay for every substances inside and proving linalool as a key substance. To prove the effect of linalool then, this study will compare diffused lavender extract essential oil aromatherapy with placebo to determine its effect as anxiety reliever

Detailed Description

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The objective in this clinical trial is to evaluate linalool effect in lavender extract essential oil aromatherapy as anti-anxiety towards pain. The linalool inside lavender extract will be proven with GC-MS assay first. Then after linalool has been confirmed as key substances inside the extract, the lavender extract essential oil will be mixed with water to dilute before it is exposed to participants in experimental group. This study will assess anxiety and pain scale using Numeric Rating Scale (NRS) for pain score and State-Trait Anxiety Inventory (STAI) before exposure and 15 minutes after the exposure has 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 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.

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.

Allocation:

\- Participant will be alloted using simple randomization to experimental or placebo group

Group/Arm:

* Experimental Group (Lavender Aromatherapy group)
* Placebo Control Group

Intervention:

* Experimental group using Young Living Lavender Extract Essential Oil to be diffused and exposed to participants as inhalation therapy in experimental group. It consist 2 mL of lavender extract essential oil diluted in 40 mL water (H2O). It will be exposed to participants for 30 minutes
* Placebo / Control group will be exposed to diffused water (H2O) for 30 minutes

Outcome:

* Primary Outcome: Anxiety scale assessed using STAI Questionnaire
* Secondary Outcome : Pain scale assessed using NRS Questionnaire

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 pain conventional therapy as a complementary therapy
* Widely accessible
* Prices range vary
* Enhances treatment and prevent reduce function or reduced quality of life

Conditions

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Anxiety Pain Aromatherapy

Keywords

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Aromatherapy Lavandula Anxiety Anxiety Disorder Pain Mind-Body Therapies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be plotted into two groups, consist of experimental group and controls group, participation allocation will be randomized
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers
Participant will not get any information of what substances that will be the exposure or what group they are added in Care provider will received bottle A and B without any explanation what substances inside the bottle. Then the care provider will set the diffuser and diffused the substances for 30 minutes to participants

Study Groups

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Lavender Aromatherapy Group

This group will be consist of 34 participants that already randomized. This group will be exposed to lavender aromatherapy

Group Type EXPERIMENTAL

Lavender Extract Aromatherapy

Intervention Type COMBINATION_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

Control Group

This control will be exposed to water diffused gas as a control to experimental group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

This intervention will be just an exposure of diffused water (H2O) for 30 minutes as a control to experimental group

Interventions

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Lavender Extract 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

Intervention Type COMBINATION_PRODUCT

Placebo

This intervention will be just an exposure of diffused water (H2O) for 30 minutes as a control to experimental group

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitas Islam Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Angga Ardhan Derryawan, MD

Mr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angga A Derryawan, MD

Role: PRINCIPAL_INVESTIGATOR

Universitas Islam Indonesia

Locations

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Ludira Husada Hospital

Yogyakarta, D.I.Yogyakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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9/Ka.Kom.Et/70/KE/I/2023

Identifier Type: -

Identifier Source: org_study_id