Clinical trial NCT06598904: The Effect of Aromatherapy for First Dental Visit Patients
Official title: The Effect of Aromatherapy on Anxiety and Pain for First Dental Visit Patients: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Anxiety
Keywords: dental anxiety
aromatherapy
first dental visit
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients who never visited dental clinics before;
* Patients who need dental treatment, such as resin filling, root canal treatment, periodontal initial treatment, tooth extraction, etc;
* Patients and their guardians who are able to understand the purpose of the study and volunteer to take part in the study;
* Patients who are intellectually sufficient to complete the anxiety scale;
* Be able to complete all assessments and follow-up during the study.

Exclusion Criteria:

* Patients who are allergic to the ingredients of the essential oils used in the experiment or to the materials used in the dental treatment;
* Patients who underwent only an oral examination;
* Patients with severe heart disease, hypertension, respiratory disease, or other systemic conditions that were not eligible for trial participation;
* Pregnant or lactating women;
* People with depressive symptoms, anxiety disorders or other mental illnesses that affect their mood state;
* People who are using sedative or analgesic drugs;
* Recent or current users of essential oils;
* Any circumstances considered by the investigator to be inappropriate for participation in this study.

Primary outcomes:
measure: Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS)
timeFrame: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation.
measure: Pain scale - Visual Analog Scale (VAS)
timeFrame: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation.
Secondary outcomes:
measure: Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S)
timeFrame: 5 minutes before operation/ immediately after operation.
measure: Vital sign 1 - systolic blood pressure (SBP)
timeFrame: 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.
measure: Vital sign 2 - diastolic blood pressure (DBP)
timeFrame: 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.
measure: Vital sign 3 - heart rate (HR）
timeFrame: 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.
measure: Vital sign 4 - oxygen saturation (SpO2）
timeFrame: 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Stomatology SIchuan University
state: Sichuan
Study officials:
References: