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

NCT06066073 | Completed DMC

• 1 other identifier: EA/3006/2018
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Pain; Anxiety; Fear; Stress

Outcome Measures

Primary Outcomes (2)

• Anxiety score

  Measured by Dental anxiety was measured by the Modified Dental Anxiety Scale (MDAS) questionnaire

  20 minutes after exposure

• 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 Outcomes (1)

• Blood pressure

  20 minutes after exposure

Study Arms (2)

Lavender group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Drug: Distal Water

Interventions

Lavender Oil 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

Also known as: Lavandula angustifolia.

Lavender group

Distal Water DRUG

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

Also known as: Deionized water

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

College of Dentistry, Qassim University

Buraidah, Al-Qassim Region, 1162, Saudi Arabia

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ghada A Khalifa, Professor

  College of Dentistry, Qassim University, Saudi Arabia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Maxillofacial Surgery and Diagnostic Science

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: October 4, 2023
• Study Start: December 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: January 15, 2021
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)