Influence of Lavender Oil on Vital Signs in Oral Surgery Patients

Study Overview
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Brief Summary
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The aim of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, mood, vital signs (blood pressure, respiratory rate, heart rate and saturation) for oral surgery patients.

Detailed Description
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Lavender oil has sedative properties. Oral surgical procedures have been proven as to be the greatest concern among dental practices for patients. Limited randomized clinical trials have demonstrated evidence-based results of lavender oil, despite being the most effective essential oil for anxiety and stress. The hypothesis of the present study was that the inhalation of lavender oil prior to oral surgical procedures may reduce anxiety and consequently may effect intra and post-operative blood pressure, inspiration and heart rate.

Official Title
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Influence of Lavender Oil on Vital Signs and Anxiety in Oral Surgery Patients: a Randomized Controlled Clinical Trial

Conditions
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Dental Anxiety, Sedative; Anxiety Disorder

Intervention / Treatment
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* Behavioral: Inhalation
* Other: Anxiety Questionnaires 1
* Other: Anxiety Questionnaires 2
* Diagnostic Test: Vital Signs 1
* Diagnostic Test: Vital Signs 2
* Diagnostic Test: Vital Signs 3
* Diagnostic Test: Vital Signs 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of wisdom tooth Must be similar in age-height-weight Must be similar socio-culturally Exclusion Criteria: Under 18 years of age Taking psychotropic medication or psychiatric treatment Systemically unhealthy patients Pregnants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lavender oil group (A)<br>100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to surgery. Anxiety questionnaires 1 (MDAS) Anxiety questionnaires 2 (STAI-S) Vital signs 1 (Blood pressure) Vital signs 2 (respiratory rate,) Vital signs 3 (heart rate) Vital signs 4 (saturation) | Behavioral: Inhalation<br>* lavender oil inhalation in a separate room for 3 minutes prior to surgery<br>* Other names: lavender oil application;Other: Anxiety Questionnaires 1<br>* Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.<br>* Other names: Modified Dental Anxiety Scale;Other: Anxiety Questionnaires 2<br>* State-Trait Anxiety Inventory-State Scale was used to distinguish the true anxiety level of the patients from the anxiety level for a particular situation.<br>* Other names: State-Trait Anxiety Inventory-State Scale;Diagnostic Test: Vital Signs 1<br>* Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.<br>* Other names: Blood Pressure;Diagnostic Test: Vital Signs 2<br>* Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.<br>* Other names: Respiratory rate;Diagnostic Test: Vital Signs 3<br>* Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.<br>* Other names: Heart rate;Diagnostic Test: Vital Signs 4<br>* Changes in vital signs 4 - saturation - before, during and after the procedure were noted.<br>* Other names: Saturation;|
| Sham Comparator: control group (B)<br>No application of lavender oil, prior to surgery. Anxiety questionnaires 1 (MDAS) Anxiety questionnaires 2 (STAI-S) Vital signs 1 (Blood pressure) Vital signs 2 (respiratory rate,) Vital signs 3 (heart rate) Vital signs 4 (saturation) | Other: Anxiety Questionnaires 1<br>* Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.<br>* Other names: Modified Dental Anxiety Scale;Other: Anxiety Questionnaires 2<br>* State-Trait Anxiety Inventory-State Scale was used to distinguish the true anxiety level of the patients from the anxiety level for a particular situation.<br>* Other names: State-Trait Anxiety Inventory-State Scale;Diagnostic Test: Vital Signs 1<br>* Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.<br>* Other names: Blood Pressure;Diagnostic Test: Vital Signs 2<br>* Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.<br>* Other names: Respiratory rate;Diagnostic Test: Vital Signs 3<br>* Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.<br>* Other names: Heart rate;Diagnostic Test: Vital Signs 4<br>* Changes in vital signs 4 - saturation - before, during and after the procedure were noted.<br>* Other names: Saturation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital Sign Measurements - 1 - changes in blood pressure | changes in blood pressure | through study completion an average of 3 months | 
| Vital Sign Measurements - 2 - changes in respiratory rate | changes in respiratory rate | through study completion an average of 3 months | 
| Vital Sign Measurements - 3 - changes in heart rate | changes in heart rate | through study completion an average of 3 months | 
| Vital Sign Measurements - 4 - changes in saturation level | changes in saturation level | through study completion an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Test 1 - MDAS tests | MDAS tests | through study completion an average of 3 months | 
| Anxiety Test 2 - STAI-S tests | STAI-S tests | through study completion an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lavandula, phytotherapy, aromatherapy, dental anxiety, anaesthesia