Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Treatment for Pain

NCT07305493 | Completed DMC

• 1 other identifier: 9/Ka.Kom.Et/70/KE/I/2023
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pain; Aromatherapy; Anxiety

Keywords

Aromatherapy; Lavandula; Anxiety; Anxiety Disorder; Pain; Mind-Body Therapies

Outcome Measures

Primary Outcomes (1)

• 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

  Before exposure and 15 minutes after exposure has done

Secondary Outcomes (1)

• Pain Scale

  Before exposure and 15 minutes after exposure has done

Study Arms (2)

Lavender Aromatherapy Group

EXPERIMENTAL

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

Combination Product: Lavender Extract Aromatherapy

Control Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Placebo OTHER

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

Control Group

Lavender Extract Aromatherapy 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

Lavender Aromatherapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Islam Indonesia: lead

Study Sites (1)

Ludira Husada Hospital

Yogyakarta, D.I.Yogyakarta, 55244, Indonesia

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Angga A Derryawan, MD

  Universitas Islam Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will be plotted into two groups, consist of experimental group and controls group, participation allocation will be randomized

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: October 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 29, 2023
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Supporting information will be available until end of December 2027 (4 years after the study has completed)
• Access Criteria: Anyone who studying / researching and needed raw data can contact this study principal investigator to access this study raw data

Locations

ID (1)