Effects of Aromatherapy on Anxiety and Pain During Dental Treatment in Adults: a Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS)
Time Frame: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation
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.
Pain scale - Visual Analog Scale (VAS)
Time Frame: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation
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.
Secondary Outcomes
- Vital sign 2 - diastolic blood pressure (DBP)(5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation)
- Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S)(5 minutes before operation/ immediately after operation)
- Vital sign 1 - systolic blood pressure (SBP)(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）(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）(5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation)
Investigators
He Cai
Assistant Researcher
Sichuan University