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NCT Number: NCT06598904

The Effect of Aromatherapy for First Dental Visit Patients

First dental visit experience is strongly correlated with dental anxiety, the aim of this protocol is to explore the efficacy of olfactory aromatherapy for the reduce of dental anxiety and pain in first-visit patient.

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Key information

Conditions

Dental Anxiety

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who never visited dental clinics before;
  • Patients who need dental treatment, such as resin filling, root canal treatment, periodontal initial treatment, tooth extraction, etc;
  • Patients and their guardians who are able to understand the purpose of the study and volunteer to take part in the study;
  • Patients who are intellectually sufficient to complete the anxiety scale;
  • 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 oils;
  • Any circumstances considered by the investigator to be inappropriate for participation in this study.

Treatment and study plan

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

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

Aroma diffuser with deionized 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 deionized water.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

He Cai, MD PhD

CONTACT

[email protected]

+86-13281167556

Sponsors and collaborators

Lead sponsor

Sichuan University

Other

Registry information

Official study title

The Effect of Aromatherapy on Anxiety and Pain for First Dental Visit Patients: a Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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