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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavender oil group | Experimental | 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) |
|
| Control group | Sham Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anxiety scale | Other | Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nazife Begüm KARAN | Ankara | Merkez | 83TR2WATUF | Turkey (Türkiye) | ||
| Nazife Begüm KARAN |
Beginning 3 months and ending 5 years following article publication all data will be shared with other researchers
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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Double (Investigator, Outcomes Assessor)
| Pain scale - 1 | Other | Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction |
|
| Pain scale - 2 | Other | Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction |
|
| Inhalation | Behavioral | lavender oil inhalation in a separate room for 3 minutes prior to interventions |
|
|
| 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 |
| Rize |
| Merkez |
| 053100 |
| Turkey (Türkiye) |