"Pain and Emotional Changes on Relationships Between Anxiety and Olfaction"

September 30, 2023 updated by: Ghada Amin Khalifa, PhD, Qassim University

Pain Perception and Emotional Changes On The Relationships Between Dental Anxiety And Olfaction: A Double-blinded Randomized Control Trial

Introduction: This prospective study aimed to assess the impact of olfaction on providing positive emotional responses and reducing dental anxiety and pain.

Material: A randomized double-blinded controlled study was enrolled on female patients. The olfaction was stimulated via lavender essential oils. Patients were divided into lavender and control groups. Patients in lavender group inhaled 2 % lavender vapors. In control group, patients inhaled distal water vapors. The variables included pain, anxiety, and vital signs. Anxiety was measured through Modified Dental Anxiety Scale (MDAS) and Speilberger State-Trait Anxiety Inventory (STAI) questionnaires. Pain was evaluated through visual analog scales (VAS). Vital signs included the systolic (SBP) and diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR), and oxygen saturation (Spo2). All variables were assessed before the intervention, 20 minutes after inhalation of vapors, and at the end of dental settings. The last evaluation was on the day after visits. P-values < 0.05 were considered significant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ABSTRACT:

Background: The purpose of the study was to determine to what extent olfactory aromatherapy reduces the intensity of dental pain and the level of dental anxiety. It also attempted to corelate between olfactory aromatherapy, stages of dental visits, and various dental procedures.

Methods: Female patients were enrolled in a randomized controlled study. Olfactory aromatherapy was performed using lavender oils. Patients were randomly assigned to one of two groups: the lavender group, in which patients inhaled 2% lavender vapors, and the control group, in which patients inhaled water vapors. Pain score, anxiety score, and changes in vital signs were among the predictable variables. Anxiety and pain were assessed using the Modified Dental Anxiety Scale (MDAS), Speilberger State-Trait Anxiety Inventory (STAI), and visual analog scales (VAS). The vital signs were systolic (SBP) and diastolic (DBP), heart rate (HR), respiratory rate (RR), and oxygen saturation (Spo2). Variables were evaluated before inhalations, 20 minutes after inhalations, at the end of settings, and on the following day.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Qassim Region
      • Buraydah, Qassim Region, Saudi Arabia, 1162
        • College of Dentistry, Qassim University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult females over 18 years,
  • Attending morning sessions of clinics (9 am),

  • Liable for administration of local anesthesia, tooth preparation either for:

    1. Filling procedures or crown preparations
    2. Endodontic treatment
    3. Teeth extraction
    4. Eubgingival scaling

Exclusion Criteria:

  • Males

  • Females who had:

    1. Allergies
    2. Bronchial asthma
    3. Common cold
    4. Pulmonary diseases
    5. Migraine

  • Females who taking:

    1. Antidepressants
    2. Anxiolytic drugs
    3. Opioids
    4. Other medications that affect emotional responses
  • Pregnant females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lavender group
Patients who were included in this group were subjected to vapors of the lavender oil in waiting rooms, during dental therapy, and on day after dental procedures
Drug: Lavender Oil
Twenty drops of lavender oil was added the distal water which fill the vaporizer which were placed in the waiting room. The patients inhaled the vapors of the lavender oil 20 minutes before starting the dental procedures
Other Names:
  • Lavandula angustifolia.
Placebo Comparator: Control group
Patients who were included in this group were subjected to vapors of distal water in waiting rooms and during dental therapy
Drug: Distal Water
The patients inhaled vapors of the distal water in the waiting room 20 minutes before starting dental procedures
Other Names:
  • Deionized water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety score
Time Frame: 20 minutes after exposure
Measured by Dental anxiety was measured by the Modified Dental Anxiety Scale (MDAS) questionnaire
20 minutes after exposure
Pain Score
Time Frame: 20 minutes after exposure
Measured by a visual analog scale (VAS).These pain scales give people a simple way to rate their pain intensity using a verbal or visual descriptor of their pain. Some examples would be the words "mild," "discomforting," "distressing," "horrible," and "excruciating."
20 minutes after exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 20 minutes after exposure
The patients were asked to stand up straight, and the sphygmomanometer cuff was inserted around their upper left arms, with a 2.5-inch distance between the antecubital fossa of the arm and the lower edge of the cuff. The blood pressure was measured after the stethoscope was placed over the brachial artery
20 minutes after exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qassim University

Investigators

  • Study Director: Ghada A Khalifa, Professor, College of Dentistry, Qassim University, Saudi Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

September 30, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 30, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA/3006/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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