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

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Lavender Oil
Distal Water
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring Pain, Anxiety, Fear, Stress

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Adult females over 18 years, Attending morning sessions of clinics (9 am), Liable for administration of local anesthesia, tooth preparation either for: Filling procedures or crown preparations Endodontic treatment Teeth extraction Eubgingival scaling Exclusion Criteria: Males Females who had: Allergies Bronchial asthma Common cold Pulmonary diseases Migraine Females who taking: Antidepressants Anxiolytic drugs Opioids Other medications that affect emotional responses Pregnant females

Sites / Locations

  • College of Dentistry, Qassim University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lavender group

Control group

Arm Description

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

Patients who were included in this group were subjected to vapors of distal water in waiting rooms and during dental therapy

Outcomes

Primary Outcome Measures

Anxiety score
Measured by Dental anxiety was measured by the Modified Dental Anxiety Scale (MDAS) questionnaire
Pain Score
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."

Secondary Outcome Measures

Blood pressure
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

Full Information

First Posted
May 18, 2021
Last Updated
September 30, 2023
Sponsor
Qassim University
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1. Study Identification

Unique Protocol Identification Number
NCT06066073
Brief Title
"Pain and Emotional Changes on Relationships Between Anxiety and Olfaction"
Official Title
Pain Perception and Emotional Changes On The Relationships Between Dental Anxiety And Olfaction: A Double-blinded Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Pain, Anxiety, Fear, Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lavender group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients who were included in this group were subjected to vapors of distal water in waiting rooms and during dental therapy
Intervention Type
Drug
Intervention Name(s)
Lavender Oil
Other Intervention Name(s)
Lavandula angustifolia.
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Distal Water
Other Intervention Name(s)
Deionized water
Intervention Description
The patients inhaled vapors of the distal water in the waiting room 20 minutes before starting dental procedures
Primary Outcome Measure Information:
Title
Anxiety score
Description
Measured by Dental anxiety was measured by the Modified Dental Anxiety Scale (MDAS) questionnaire
Time Frame
20 minutes after exposure
Title
Pain Score
Description
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."
Time Frame
20 minutes after exposure
Secondary Outcome Measure Information:
Title
Blood pressure
Description
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
Time Frame
20 minutes after exposure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adult females over 18 years, Attending morning sessions of clinics (9 am), Liable for administration of local anesthesia, tooth preparation either for: Filling procedures or crown preparations Endodontic treatment Teeth extraction Eubgingival scaling Exclusion Criteria: Males Females who had: Allergies Bronchial asthma Common cold Pulmonary diseases Migraine Females who taking: Antidepressants Anxiolytic drugs Opioids Other medications that affect emotional responses Pregnant females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghada A Khalifa, Professor
Organizational Affiliation
College of Dentistry, Qassim University, Saudi Arabia
Official's Role
Study Director
Facility Information:
Facility Name
College of Dentistry, Qassim University
City
Buraydah
State/Province
Qassim Region
ZIP/Postal Code
1162
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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