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

NCT ID: NCT06066073

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2021-01-15

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.

Conditions

Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Lavender Oil

Intervention Type: DRUG

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

Control group

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

Group Type: PLACEBO_COMPARATOR

Distal Water

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Distal Water

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

Intervention Type: DRUG

Other Intervention Names

Lavandula angustifolia.; Deionized water

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:

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Qassim University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Amin Khalifa, PhD

Professor of Maxillofacial Surgery and Diagnostic Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada A Khalifa, Professor

Role: STUDY_DIRECTOR

College of Dentistry, Qassim University, Saudi Arabia

Locations

College of Dentistry, Qassim University

Buraidah, Al-Qassim Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

EA/3006/2018

Identifier Type: -

Identifier Source: org_study_id