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Recruiting NCT06347679

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

No phase Interventional Dental Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aroma diffuser with single-note sweet orange essential oil, Aroma diffuser with single-note tea tree essential oil, Aroma diffuser with water.
Who it may be relevant to
Registry conditions: Dental Anxiety. Basic parameters: 18 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • 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]
  • Pain scale - Visual Analog Scale (VAS) [Time frame: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation]
Secondary outcome measures (5)
  • Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S) [Time frame: 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • West China Hospital of Stomatology SIchuan University — Chengdu

Identifiers

NCT: NCT06347679 · WCHSIRB-CT-2024-160

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗