Effects of Aromatherapy on Anxiety and Pain During Dental Treatment in Adults

Effects of Aromatherapy on Anxiety and Pain During Dental Treatment in Adults: a Randomized Controlled Clinical Trial

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 Overview

• Status: Recruiting
• Conditions: Dental Anxiety
• Intervention / Treatment: Other: Aroma diffuser with single-note sweet orange essential oil; Other: Aroma diffuser with single-note tea tree essential oil; Other: Aroma diffuser with water

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: He Cai, MD PhD; Phone Number: +86-13281167556; Email: caihe.dr@scu.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Stomatology Sichuan University
      • Contact: He Cai, Phd; Phone Number: +86-13281167556; Email: caihe.dr@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: single-note sweet orange essential oil	Other: Aroma diffuser with single-note sweet orange essential oil; 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 sweet orange essential oil into the aroma diffuser reservoir containing 120 ml of water.
Experimental: Group 2: single-note tea tree essential oil	Other: Aroma diffuser with single-note tea tree essential oil; 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 tea tree essential oil into the aroma diffuser reservoir containing 120 ml of water.
Sham Comparator: Group 3: water	Other: Aroma diffuser with 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 water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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,	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

Collaborators and Investigators

• Sponsor: Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: WCHSIRB-CT-2024-160

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No