The Effect of Aromatherapy for First Dental Visit Patients

The Effect of Aromatherapy on Anxiety and Pain for First Dental Visit Patients: a Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Anxiety
• Intervention / Treatment: Other: Aroma diffuser with single-note lavender essential oil; Other: Aroma diffuser with single-note orange essential oil; Other: Aroma diffuser with deionized 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
      • 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 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.

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 lavender essential oil; Aroma diffuser with single-note lavender essential oil.	Other: Aroma diffuser with single-note lavender 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 lavender essential oil into the aroma diffuser reservoir containing 120 ml of water.
Experimental: Group 2: single-note orange essential oil; Aroma diffuser with single-note orange essential oil	Other: Aroma diffuser with single-note 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 orange essential oil into the aroma diffuser reservoir containing 120 ml of water.
Placebo Comparator: Group 3: deionized water; 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 water into the aroma diffuser reservoir containing 120 ml of deionized 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 (Estimated): September 20, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: aromatherapy; dental anxiety; first dental visit
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: WCHS-CRSE-2024-128-R1-P

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