Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:29 AM
Study NCT ID:
NCT07305493
Status:
COMPLETED
Last Update Posted:
2026-01-02
First Post:
2025-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Treatment for Pain
Sponsor:
Universitas Islam Indonesia
Organization:
Study Overview
Official Title:
The Use of Lavender (Lavandula Angustifolia) Aromatherapy Inhalation as an Anti-Anxiety Toward Pain
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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: 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: