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

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Drug: Distal Water; Drug: Lavender Oil

• Registration Number: NCT06066073
• Lead Sponsor: Qassim University

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.

Study Timeline

• Study Start: 2017-12-01
• Primary Completion: 2020-09-01
• Study Completion: 2021-01-15
• Study First Submitted: 2021-05-18
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-30
• Last Update Submitted: 2023-09-30
• Study First Posted: 2023-10-04
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 350

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Distal Water	Patients who were included in this group were subjected to vapors of distal water in waiting rooms and during dental therapy
Lavender group	Lavender Oil	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

Primary Outcome Measures

Name	Time	Method
Pain Score	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."
Anxiety score	20 minutes after exposure	Measured by Dental anxiety was measured by the Modified Dental Anxiety Scale (MDAS) questionnaire

Secondary Outcome Measures

Name	Time	Method
Blood pressure	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

Trial Locations

Locations (1)

College of Dentistry, Qassim University; 🇸🇦 Buraydah, Qassim Region, Saudi Arabia