The Effect of Aromatherapy for First Dental Visit Patients

Not Applicable

Not yet recruiting

• Conditions: Dental Anxiety
• Interventions: Other: Aroma diffuser with single-note lavender essential oil; Other: Aroma diffuser with single-note orange essential oil; Other: Aroma diffuser with deionized water

• Registration Number: NCT06598904
• Lead Sponsor: Sichuan University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-09-20
• Primary Completion: 2025-03-31
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: single-note lavender essential oil	Aroma diffuser with single-note lavender essential oil	Aroma diffuser with single-note lavender essential oil.
Group 2: single-note orange essential oil	Aroma diffuser with single-note orange essential oil	Aroma diffuser with single-note orange essential oil
Group 3: deionized water	Aroma diffuser with deionized water	Aroma diffuser with deionized water.

Primary Outcome Measures

Name	Time	Method
Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS)	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)	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 Outcome Measures

Name	Time	Method
Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S)	5 minutes before operation/ immediately after operation.	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.
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.	Systolic blood pressure (SBP) is measured using a manual sphygmomanometer, before, during and after operation.
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.	Diastolic blood pressure (DBP) is measured using a manual sphygmomanometer, before, during and 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.	Heart rate (HR) is measured as pulse rate using an oximeter, before, during and 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.	Oxygen saturation (SpO2）is measured using an oximeter, before, during and after operation.

Trial Locations

Locations (1)

West China Hospital of Stomatology SIchuan University; 🇨🇳 Chengdu, Sichuan, China