Aromatherapy With Lavender Essential Oil as a Complementary Treatment for the Control of Dental Anxiety
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2020
CompletedFirst Posted
Study publicly available on registry
February 26, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedFebruary 26, 2020
February 1, 2020
Same day
February 21, 2020
February 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (6)
Heart rate
5 minutes Before aromatherapy
Heart rate
30 minutes after aromatherapy
Respiratory rate
5 minutes Before aromatherapy
Respiratory rate
30 minutes after aromatherapy
Arterial pressure
5 minutes Before aromatherapy
- +1 more secondary outcomes
Study Arms (2)
Aromatherapy
EXPERIMENTAL0.10 ml of lavender essential oil 30 minutes prior surgery
Sham Aromatherapy
SHAM COMPARATOR0.10 ml mineral oil 30 minutes prior surgery
Interventions
Eligibility Criteria
You may qualify if:
- Volunteer to take part in the study
- Healthy patients
- Patients signing the informed consent
- Patients who need surgical removal of third molars
You may not qualify if:
- Hypertensive patients
- Patients with nasal congestion problems
- Patients allergic to lavender.
- Patients under treatment with anti depressants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liliana Argueta-Figueroa, DMD PhD
UABJO
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 21, 2020
First Posted
February 26, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2020
Study Completion
May 1, 2020
Last Updated
February 26, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Starting 6 months after publication in journal
- Access Criteria
- For meta analysis purposes, after contact with the PI
Measures of cortisol, vital sign, Corah scale, sex and age.