The Effect of Aromatherapy for First Dental Visit Patients

NCT ID: NCT06598904

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-20

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Group 1: single-note lavender essential oil

Aroma diffuser with single-note lavender essential oil.

Group Type EXPERIMENTAL

Aroma diffuser with single-note lavender essential oil

Intervention Type 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.

Group 2: single-note orange essential oil

Aroma diffuser with single-note orange essential oil

Group Type EXPERIMENTAL

Aroma diffuser with single-note orange essential oil

Intervention Type 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.

Group 3: deionized water

Aroma diffuser with deionized water.

Group Type PLACEBO_COMPARATOR

Aroma diffuser with deionized water

Intervention Type 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.

Interventions

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

Intervention Type OTHER

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

Intervention Type OTHER

Aroma diffuser with deionized 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 deionized water.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sichuan University

OTHER

Sponsor Role lead

Responsible Party

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He Cai

Post Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital of Stomatology SIchuan University

Chengdu, Sichuan, China

Site Status

Countries

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China

Central Contacts

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He Cai, MD PhD

Role: CONTACT

+86-13281167556

Facility Contacts

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He Cai, Phd

Role: primary

+86-13281167556

Other Identifiers

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WCHS-CRSE-2024-128-R1-P

Identifier Type: -

Identifier Source: org_study_id

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