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

Dental Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06347679
• Other study ID #: WCHSIRB-CT-2024-160
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2024
• Source: Sichuan University
• Contact: He Cai, MD PhD
• Phone: +86-13281167556
• Email: caihe.dr[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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