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

Primary Purpose

Dental Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lavender aromatherapy
Sham aromatherapy
Sponsored by
Universidad Autónoma Benito Juárez de Oaxaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety focused on measuring aromatherapy, lavender, anxiety

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Aromatherapy

    Sham Aromatherapy

    Arm Description

    0.10 ml of lavender essential oil 30 minutes prior surgery

    0.10 ml mineral oil 30 minutes prior surgery

    Outcomes

    Primary Outcome Measures

    Corah
    Corah's Dental Anxiety Scale (1-25). Non anxiety (0-8), moderate (9-12), high (13-14), severe (over 15)
    Cortisol
    Salivary Cortisol Testing (ng/mL)
    Cortisol
    Salivary Cortisol Testing (ng/mL)

    Secondary Outcome Measures

    Heart rate
    The speed of the heartbeat measured by the number of contractions of the heart per minute
    Heart rate
    The speed of the heartbeat measured by the number of contractions of the heart per minute
    Respiratory rate
    The number of breaths per minute.
    Respiratory rate
    The number of breaths per minute.
    Arterial pressure
    The pressure of circulating blood on the walls of blood vessels. (mm/Hg) sphingomanometer OMRON model HEM-7114
    Arterial pressure
    The pressure of circulating blood on the walls of blood vessels. (mm/Hg) sphingomanometer OMRON model HEM-7114

    Full Information

    First Posted
    February 21, 2020
    Last Updated
    February 24, 2020
    Sponsor
    Universidad Autónoma Benito Juárez de Oaxaca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04285385
    Brief Title
    Aromatherapy With Lavender Essential Oil as a Complementary Treatment for the Control of Dental Anxiety
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2020 (Anticipated)
    Primary Completion Date
    March 2020 (Anticipated)
    Study Completion Date
    May 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Autónoma Benito Juárez de Oaxaca

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Anxiety
    Keywords
    aromatherapy, lavender, anxiety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Aromatherapy
    Arm Type
    Experimental
    Arm Description
    0.10 ml of lavender essential oil 30 minutes prior surgery
    Arm Title
    Sham Aromatherapy
    Arm Type
    Sham Comparator
    Arm Description
    0.10 ml mineral oil 30 minutes prior surgery
    Intervention Type
    Other
    Intervention Name(s)
    Lavender aromatherapy
    Intervention Description
    0.10 ml of lavender essential oil
    Intervention Type
    Other
    Intervention Name(s)
    Sham aromatherapy
    Intervention Description
    0.10 ml of mineral oil
    Primary Outcome Measure Information:
    Title
    Corah
    Description
    Corah's Dental Anxiety Scale (1-25). Non anxiety (0-8), moderate (9-12), high (13-14), severe (over 15)
    Time Frame
    45 minutes before dental treatment
    Title
    Cortisol
    Description
    Salivary Cortisol Testing (ng/mL)
    Time Frame
    5 minutes Before aromatherapy
    Title
    Cortisol
    Description
    Salivary Cortisol Testing (ng/mL)
    Time Frame
    30 minutes after aromatherapy
    Secondary Outcome Measure Information:
    Title
    Heart rate
    Description
    The speed of the heartbeat measured by the number of contractions of the heart per minute
    Time Frame
    5 minutes Before aromatherapy
    Title
    Heart rate
    Description
    The speed of the heartbeat measured by the number of contractions of the heart per minute
    Time Frame
    30 minutes after aromatherapy
    Title
    Respiratory rate
    Description
    The number of breaths per minute.
    Time Frame
    5 minutes Before aromatherapy
    Title
    Respiratory rate
    Description
    The number of breaths per minute.
    Time Frame
    30 minutes after aromatherapy
    Title
    Arterial pressure
    Description
    The pressure of circulating blood on the walls of blood vessels. (mm/Hg) sphingomanometer OMRON model HEM-7114
    Time Frame
    5 minutes Before aromatherapy
    Title
    Arterial pressure
    Description
    The pressure of circulating blood on the walls of blood vessels. (mm/Hg) sphingomanometer OMRON model HEM-7114
    Time Frame
    30 minutes after aromatherapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rafael Torres, MD PhD
    Phone
    (52) (951) 1448276
    Email
    rtorres.cat@uabjo.mx
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liliana Argueta-Figueroa, DMD PhD
    Organizational Affiliation
    UABJO
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

    Learn more about this trial

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

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