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

May 13, 2025 updated by: He Cai, Sichuan University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Stomatology Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: single-note sweet orange essential oil
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.
Experimental: Group 2: single-note tea tree essential oil
Other: 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.
Sham Comparator: Group 3: water
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS)
Time Frame: 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.
5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation
Pain scale - Visual Analog Scale (VAS)
Time Frame: 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.
5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S)
Time Frame: 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,
5 minutes before operation/ immediately after operation
Vital sign 1 - systolic blood pressure (SBP)
Time Frame: 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.
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)
Time Frame: 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.
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）
Time Frame: 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.
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）
Time Frame: 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.
5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • WCHSIRB-CT-2024-160

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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