Dental AnxietyNCT06598904
The Effect of Aromatherapy for First Dental Visit Patients
A study testing Aroma diffuser with single-note lavender essential oil, Aroma diffuser with single-note orange essential oil and Aroma diffuser with deionized water in people with Dental Anxiety, run by Sichuan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Aroma diffuser with single-note lavender essential oil, Aroma diffuser with single-note orange essential oil and Aroma diffuser with deionized water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital of Stomatology SIchuan University
Chengdu, Sichuan, 610041
He Cai, Phd, +86-13281167556, caihe.dr@scu.edu.cn
About this study
Official title: The Effect of Aromatherapy on Anxiety and Pain for First Dental Visit Patients: a Randomized Controlled Clinical Trial
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.
- Conditions
- Dental Anxiety
- Being tested
- Aroma diffuser with single-note lavender essential oil, Aroma diffuser with single-note orange essential oil, Aroma diffuser with deionized water
- Keywords
- dental anxiety, aromatherapy, first dental visit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aroma diffuser with single-note lavender essential oilOther
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 oilOther
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 waterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: single-note lavender essential oil | Experimental | Aroma diffuser with single-note lavender essential oil. Receives: Other: Aroma diffuser with single-note lavender essential oil |
| Group 2: single-note orange essential oil | Experimental | Aroma diffuser with single-note orange essential oil Receives: Other: Aroma diffuser with single-note orange essential oil |
| Group 3: deionized water | Placebo comparator | Aroma diffuser with deionized water. Receives: Other: Aroma diffuser with deionized water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation.
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.
Measured: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation.
Secondary outcomes (5)
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.
Measured: 5 minutes before operation/ immediately after operation.
Vital sign 1 - systolic blood pressure (SBP)
Systolic blood pressure (SBP) is measured using a manual sphygmomanometer, before, during and after operation.
Measured: 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)
Diastolic blood pressure (DBP) is measured using a manual sphygmomanometer, before, during and after operation.
Measured: 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）
Heart rate (HR) is measured as pulse rate using an oximeter, before, during and after operation.
Measured: 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）
Oxygen saturation (SpO2）is measured using an oximeter, before, during and after operation.
Measured: 5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Cai, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598904
- Sponsor's protocol ID
- WCHS-CRSE-2024-128-R1-P
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy on Anxiety and Pain for First Dental Visit Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06598904
- Acronym / sponsor ID
- WCHS-CRSE-2024-128-R1-P
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, aromatherapy, first dental visit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: single-note lavender essential oil | Experimental | Other: Aroma diffuser with single-note lavender essential oilAroma diffuser with single-note lavender essential oil. |
| Group 2: single-note orange essential oil | Experimental | Other: Aroma diffuser with single-note orange essential oilAroma diffuser with single-note orange essential oil |
| Group 3: deionized water | Placebo comparator | Other: Aroma diffuser with deionized waterAroma diffuser with deionized water. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aroma diffuser with single-note lavender essential oilIn 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. | Other | Group 1: single-note lavender essential oil |
| Aroma diffuser with single-note orange essential oilIn 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. | Other | Group 2: single-note orange essential oil |
| Aroma diffuser with deionized waterIn 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. | Other | Group 3: deionized water |
Primary outcome
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.
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 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aroma diffuser with single-note lavender essential oil, Aroma diffuser with single-note orange essential oil and Aroma diffuser with deionized water in people with Dental Anxiety, run by Sichuan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Cai, MD PhD (+86-13281167556, caihe.dr@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.