Health TrialsbyHealthPanel

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

ConditionDental Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorSichuan University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aroma diffuser with single-note sweet orange essential oil

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Group 1: single-note sweet orange essential oilExperimental treatment 1 intervention
Group B: Group 2: single-note tea tree essential oilExperimental treatment 1 intervention
Group C: Group 3: waterSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation
2

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.

Time frame
5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation

Secondary outcomes

1

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,

Time frame
5 minutes before operation/ immediately after operation
2

Vital sign 1 - systolic blood pressure (SBP)

systolic blood pressure (SBP) is measured using a manual sphygmomanometer, before, during and after operation.

Time frame
5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation
3

Vital sign 2 - diastolic blood pressure (DBP)

diastolic blood pressure (DBP) is measured using a manual sphygmomanometer, before, during and after operation.

Time frame
5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation
4

Vital sign 3 - heart rate (HR）

Heart rate (HR）is measured as pulse rate using an oximeter, before, during and after operation.

Time frame
5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Source ClinicalTrials.gov
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