Clinical trial NCT06347679: Effects of Aromatherapy on Anxiety and Pain During Dental Treatment in Adults
Official title: Effects of Aromatherapy on Anxiety and Pain During Dental Treatment in Adults: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Anxiety
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dental anxiety is a common problem in dental care. The aim of this protocol is to evaluate the effect of orange and tea essential oil for the control of anxiety and pain in adults during dental treatments.


Eligibility criteria: Inclusion Criteria:

* Patients who need dental treatment, such as resin filling, root canal treatment, periodontal initial treatment, tooth extraction, etc.
* Be able to understand the purpose of the study and volunteer to take part in the study.
* 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 oil.
* 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: