The Effect of Aromatherapy for First Dental Visit Patients

NCT06598904 | Not Yet Recruiting DMC

• 1 other identifier: WCHS-CRSE-2024-128-R1-P
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety

Keywords

dental anxiety; aromatherapy; first dental visit

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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 2 - diastolic blood pressure (DBP)

  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.

Study Arms (3)

Group 1: single-note lavender essential oil

EXPERIMENTAL

Aroma diffuser with single-note lavender essential oil.

Other: Aroma diffuser with single-note lavender essential oil

Group 2: single-note orange essential oil

EXPERIMENTAL

Aroma diffuser with single-note orange essential oil

Other: Aroma diffuser with single-note orange essential oil

Group 3: deionized water

PLACEBO COMPARATOR

Aroma diffuser with deionized water.

Other: Aroma diffuser with deionized water

Interventions

Aroma diffuser with single-note lavender essential oil OTHER

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.

Group 1: single-note lavender essential oil

Aroma diffuser with single-note orange essential oil OTHER

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.

Group 2: single-note orange essential oil

Aroma diffuser with deionized water OTHER

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.

Group 3: deionized water

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Stomatology SIchuan University

Chengdu, Sichuan, 610041, China

Location

Central Study Contacts

He Cai, MD PhD

CONTACT

+86-13281167556; caihe.dr@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Doctor

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)