## Protocol Section
### Identification Module
**NCT ID:** NCT06347679

**Brief Title:** Effects of Aromatherapy on Anxiety and Pain During Dental Treatments in Adults: a Randomized Controlled Clinical Trial

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

#### Organization Study ID Info
**ID:** WCHSIRB-CT-2024-160
#### Organization
**Class:** OTHER
**Full Name:** Sichuan University
### Status Module
#### Completion Date
**Date:** 2026-04-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-04

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-04-04
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-28
**Study First Submit QC Date:** 2024-03-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sichuan University

#### Responsible Party

**Investigator Affiliation:** Sichuan University

**Investigator Full Name:** He Cai

**Investigator Title:** Postdoc

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Dental Anxiety

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Aroma diffuser with single-note sweet orange essential oil

**Label:** Group 1: single-note sweet orange essential oil

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Aroma diffuser with single-note tea tree essential oil

**Label:** Group 2: single-note tea tree essential oil

**Type:** EXPERIMENTAL

#### Arm Group 3

**Intervention Names:**

- Other: Aroma diffuser with water

**Label:** Group 3: water

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1: single-note sweet orange essential oil

**Description:** 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.

**Name:** Aroma diffuser with single-note sweet orange essential oil

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Group 2: single-note tea tree essential oil

**Description:** 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.

**Name:** Aroma diffuser with single-note tea tree essential oil

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Group 3: water

**Description:** 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.

**Name:** Aroma diffuser with water

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

**Description:** 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.

**Measure:** Pain scale - Visual Analog Scale (VAS)

**Time Frame:** 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation

#### Secondary Outcomes

**Description:** 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,

**Measure:** Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S)

**Time Frame:** 5 minutes before operation/ immediately after operation

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

**Measure:** 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

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

**Measure:** 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

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

**Measure:** 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

**Description:** oxygen saturation (SpO2）is measured using an oximeter, before, during and after operation.

**Measure:** 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 Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** caihe.dr@scu.edu.cn

**Name:** He Cai, MD PhD

**Phone:** +86-13281167556

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T312

- Name: Tea

- Relevance: LOW

- As Found: Unknown

- ID: T244

- Name: Orange

- Relevance: HIGH

- As Found: Blood cells

- ID: T313

- Name: Tea Tree

- Relevance: HIGH

- As Found: Intrapulmonary

### Misc Info Module

- Version Holder: 2024-05-24
