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

NCT06347679 | Recruiting

• 1 other identifier: WCHSIRB-CT-2024-160
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety

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 sweet orange essential oil

EXPERIMENTAL

Other: Aroma diffuser with single-note sweet orange essential oil

Group 2: single-note tea tree essential oil

EXPERIMENTAL

Other: Aroma diffuser with single-note tea tree essential oil

Group 3: water

SHAM COMPARATOR

Other: Aroma diffuser with water

Interventions

Aroma diffuser with single-note sweet 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 sweet orange essential oil into the aroma diffuser reservoir containing 120 ml of water.

Group 1: single-note sweet orange essential oil

Aroma diffuser with single-note tea tree 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 tea tree essential oil into the aroma diffuser reservoir containing 120 ml of water.

Group 2: single-note tea tree essential oil

Aroma diffuser with 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 water.

Group 3: water

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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 oil.
• 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

RECRUITING

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

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: Assistant Researcher

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

CN (1)