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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06066073
• Other study ID #: EA/3006/2018
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: January 15, 2021

Study information

• Verified date: September 2023
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 15, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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
• Distal Water
The patients inhaled vapors of the distal water in the waiting room 20 minutes before starting dental procedures

Locations

Country	Name	City	State
Saudi Arabia	College of Dentistry, Qassim University	Buraydah	Qassim Region

Sponsors (1)

Lead Sponsor	Collaborator
Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety score	Measured by Dental anxiety was measured by the Modified Dental Anxiety Scale (MDAS) questionnaire	20 minutes after exposure
Primary	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."	20 minutes after exposure
Secondary	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	20 minutes after exposure