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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04285385
Other study ID # 19PEC001FO
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2020
Est. completion date May 2020

Study information

Verified date February 2020
Source Universidad Autónoma Benito Juárez de Oaxaca
Contact Rafael Torres, MD PhD
Phone (52) (951) 1448276
Email rtorres.cat@uabjo.mx
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date May 2020
Est. primary completion date March 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Lavender aromatherapy
0.10 ml of lavender essential oil
Sham aromatherapy
0.10 ml of mineral oil

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad Autónoma Benito Juárez de Oaxaca

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Cortisol Salivary Cortisol Testing (ng/mL) 5 minutes Before aromatherapy
Primary Cortisol Salivary Cortisol Testing (ng/mL) 30 minutes after aromatherapy
Secondary Heart rate The speed of the heartbeat measured by the number of contractions of the heart per minute 5 minutes Before aromatherapy
Secondary Heart rate The speed of the heartbeat measured by the number of contractions of the heart per minute 30 minutes after aromatherapy
Secondary Respiratory rate The number of breaths per minute. 5 minutes Before aromatherapy
Secondary Respiratory rate The number of breaths per minute. 30 minutes after aromatherapy
Secondary Arterial pressure The pressure of circulating blood on the walls of blood vessels. (mm/Hg) sphingomanometer OMRON model HEM-7114 5 minutes Before aromatherapy
Secondary Arterial pressure The pressure of circulating blood on the walls of blood vessels. (mm/Hg) sphingomanometer OMRON model HEM-7114 30 minutes after aromatherapy
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