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First dental visit experience is strongly correlated with dental anxiety, the aim of this protocol is to explore the efficacy of olfactory aromatherapy for the reduce of dental anxiety and pain in first-visit patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: single-note lavender essential oil | Experimental | Aroma diffuser with single-note lavender essential oil. |
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| Group 2: single-note orange essential oil | Experimental | Aroma diffuser with single-note orange essential oil |
|
| Group 3: deionized water | Placebo Comparator | Aroma diffuser with deionized water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aroma diffuser with single-note lavender essential oil | Other | In a space of 3*4*2.6 cubic meters, positioned 10 cm away from the patient, add 4-6 drops (each drop being 0.05 ml) of 100% concentration single-note lavender essential oil into the aroma diffuser reservoir containing 120 ml of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS) | The Modified Dental Anxiety Scale (MDAS) consists of 4 questions each with a 5 category rating scale, ranging from 'not anxious' to 'extremely anxious', hence, the total score varies from 4 to 20, with higher obtained scores describing more elevated levels of dental anxiety. MDAS is recorded before, during and after operation. | 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation. |
| Pain scale - Visual Analog Scale (VAS) | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." VAS is recorded before, during and after operation. | 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S) | The STAI-S evaluates the subjective feelings of tension, worry, nervousness, apprehension, and autonomic nervous system activation. This self-completed inventory consisted of 20 items on a four-point Likert scale running from one (i.e., not at all) to four (i.e., very much). Hence, the total score varies from 20 to 80, with higher obtained scores describing more elevated levels of anxiety. STAI-S is recorded before and after operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| He Cai, MD PhD | Contact | +86-13281167556 | caihe.dr@scu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Stomatology SIchuan University | Chengdu | Sichuan | 610041 | China |
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| Aroma diffuser with single-note orange essential oil | Other | In a space of 3*4*2.6 cubic meters, positioned 10 cm away from the patient, add 4-6 drops (each drop being 0.05 ml) of 100% concentration single-note orange essential oil into the aroma diffuser reservoir containing 120 ml of water. |
|
| Aroma diffuser with deionized water | Other | In a space of 3*4*2.6 cubic meters, positioned 10 cm away from the patient, add 4-6 drops (each drop being 0.05 ml) of water into the aroma diffuser reservoir containing 120 ml of deionized water. |
|
| 5 minutes before operation/ immediately after operation. |
| Vital sign 1 - systolic blood pressure (SBP) | Systolic blood pressure (SBP) is measured using a manual sphygmomanometer, before, during and after operation. | 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation. |
| Vital sign 2 - diastolic blood pressure (DBP) | Diastolic blood pressure (DBP) is measured using a manual sphygmomanometer, before, during and after operation. | 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation. |
| Vital sign 3 - heart rate (HR） | Heart rate (HR) is measured as pulse rate using an oximeter, before, during and after operation. | 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation. |
| Vital sign 4 - oxygen saturation (SpO2） | Oxygen saturation (SpO2）is measured using an oximeter, before, during and after operation. | 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation. |