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

Universitas Islam Indonesia

Status

Completed

Conditions

Aromatherapy

Anxiety

Pain

Treatments

Combination Product: Lavender Extract Aromatherapy

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT07305493

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

Details and patient eligibility

About

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.

Full 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

Enrollment

68 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.