Aromatherapy With Lavender Essential Oil as a Complementary Treatment for the Control of Dental Anxiety

Aromatherapy With Lavender Essential Oil as a Complementary Treatment for the Control of Dental Anxiety in Patients Requiring Third Molar Surgery of the "University Autonomus Benito Juarez of Oaxaca" UABJO School of Dentistry

Dental anxiety is a common problem in dental care, the aim of this protocol is to evaluate the effect of lavender for the control of anxiety during a surgical dental extraction.

Study Overview

• Status: Unknown
• Conditions: Dental Anxiety
• Intervention / Treatment: Other: Lavender aromatherapy; Other: Sham aromatherapy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rafael Torres, MD PhD; Phone Number: (52) (951) 1448276; Email: rtorres.cat@uabjo.mx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Volunteer to take part in the study
• Healthy patients
• Patients signing the informed consent
• Patients who need surgical removal of third molars

Exclusion Criteria:

• Hypertensive patients
• Patients with nasal congestion problems
• Patients allergic to lavender.
• Patients under treatment with anti depressants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Aromatherapy; 0.10 ml of lavender essential oil 30 minutes prior surgery	Other: Lavender aromatherapy; 0.10 ml of lavender essential oil
SHAM_COMPARATOR: Sham Aromatherapy; 0.10 ml mineral oil 30 minutes prior surgery	Other: Sham aromatherapy; 0.10 ml of mineral oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corah	Corah's Dental Anxiety Scale (1-25). Non anxiety (0-8), moderate (9-12), high (13-14), severe (over 15)	45 minutes before dental treatment
Cortisol	Salivary Cortisol Testing (ng/mL)	5 minutes Before aromatherapy
Cortisol	Salivary Cortisol Testing (ng/mL)	30 minutes after aromatherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	The speed of the heartbeat measured by the number of contractions of the heart per minute	5 minutes Before aromatherapy
Heart rate	The speed of the heartbeat measured by the number of contractions of the heart per minute	30 minutes after aromatherapy
Respiratory rate	The number of breaths per minute.	5 minutes Before aromatherapy
Respiratory rate	The number of breaths per minute.	30 minutes after aromatherapy
Arterial pressure	The pressure of circulating blood on the walls of blood vessels. (mm/Hg) sphingomanometer OMRON model HEM-7114	5 minutes Before aromatherapy
Arterial pressure	The pressure of circulating blood on the walls of blood vessels. (mm/Hg) sphingomanometer OMRON model HEM-7114	30 minutes after aromatherapy

Collaborators and Investigators

• Sponsor: Universidad Autónoma Benito Juárez de Oaxaca
• Investigators: Principal Investigator: Liliana Argueta-Figueroa, DMD PhD, UABJO

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (ACTUAL): February 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: anxiety; aromatherapy; lavender
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 19PEC001FO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Measures of cortisol, vital sign, Corah scale, sex and age.
• IPD Sharing Time Frame: Starting 6 months after publication in journal
• IPD Sharing Access Criteria: For meta analysis purposes, after contact with the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No