An interventional study of Aroma diffuser with single-note lavender essential oil and Aroma diffuser with single-note orange essential oil in Dental Anxiety, sponsored by Sichuan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Sichuan University · Not applicable, Interventional, and Treatment
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Sichuan University is the lead sponsor of 106 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Aroma diffuser with single-note lavender essential oil.
Other: Aroma diffuser with single-note lavender essential oil
Aroma diffuser with single-note orange essential oil
Other: Aroma diffuser with single-note orange essential oil
Aroma diffuser with deionized water.
Other: Aroma diffuser with deionized water
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.
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.
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.
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.
Time frame: 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.
Time frame: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Sichuan University