Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children

Study Overview
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Brief Summary
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The purpose of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention.

Detailed Description
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Lavender oil has sedative properties. Dental anxiety is one of the most common obstacles to dental care, especially for children ranges from 3% to 43% in different populations. To the best of our knowledge, this is the first study to investigate the use of lavender oil inhalation and to assess the correlation of anxiety and vital signs among children during a stressful surgical dental intervention. This study design was constructed according to the vital sign evaluations, anxiety and pain scores. Primary hypothesis was that of lavender oil inhalation prior to surgical dental interventions would affect vital signs and consequently reduce anxiety and perception of pain in children.

Official Title
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Can Lavender Oil Inhalation Help to Overcome Dental Anxiety and Pain in Children? A Randomized Clinical Trial

Conditions
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Dental Anxiety, Anxiety Disorder, Aromatherapy

Intervention / Treatment
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* Other: Anxiety scale
* Other: Pain scale - 1
* Other: Pain scale - 2
* Behavioral: Inhalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being between 6 and 12 years of age children who are determined as Frankl 2, 3 or 4 intellectually sufficient to complete the anxiety scale volunteer to take part in the study whose parents were willing to participate into the study Exclusion Criteria: aged under 6 has cognitive, cooperation (i.ex. Frankl 1) or systemic problems common allergies or dental pain

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 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<br>100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to tooth extractions. Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale 2 (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation) | Other: Anxiety scale<br>* Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.<br>Other: Pain scale - 1<br>* Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction<br>Other: Pain scale - 2<br>* Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction<br>Behavioral: Inhalation<br>* lavender oil inhalation in a separate room for 3 minutes prior to interventions<br>* Other names: 100 % pure, high strength lavender oil inhalation;|
| Sham Comparator: Control group<br>No application prior to interventions. No lavender oil inhalation. Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation) | Other: Anxiety scale<br>* Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.<br>Other: Pain scale - 1<br>* Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction<br>Other: Pain scale - 2<br>* Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital Sign Measurements - 1 (sistolic and diastolic blood pressure) | changes in systolic and diastolic blood pressure pre-operatively, intra-operatively, post-operatively | through study completion an average of 9 months | 
| Vital Sign Measurements - 2 (heart rate) | changes in heart rate pre-operatively, intra-operatively, post-operatively | through study completion an average of 9 months | 
| Vital Sign Measurements - 3 (saturation) | changes in saturation pre-operatively, intra-operatively, post-operatively | through study completion an average of 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety Scale - Face Image Scale (FIS) | Five cartoon faces symbolized different emotions from very happy to very unhappy. The children chose one face at which they feel most like at that moment. One point is given to most positive face and 5 point is given to most negative face. | through study completion an average of 9 months | 
| Pain Scale 1 - Face, Legs, Activity, Cry, Consolability (FLACC) | FLACC has five categories of behavior to rate pain as follows; facial expression, leg movement, activity, cry and consolability. The scores of each category are between 0 and 2. The total scores can change from 0 to 10 defined as mild (1-3), moderate (4-6) and severe (7-10). | through study completion an average of 9 months | 
| Pain Scale 2 - Wong Baker Pain Rating Scales (WBS) | WBS combines pictures and numbers to rate pain. The scale has six faces assigned numerical ratings from 0 'no hurt' to 10 'hurts worst'. Administration of WBS is easy, not time consuming and requires minimal instructions | through study completion an average of 9 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