Clinical trial NCT06066073: "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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Pain
Anxiety
Fear
Stress
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Anxiety score
timeFrame: 20 minutes after exposure
measure: Pain Score
timeFrame: 20 minutes after exposure
Secondary outcomes:
measure: Blood pressure
timeFrame: 20 minutes after exposure
Other outcomes:
Locations:
city: Buraydah
country: Saudi Arabia
facility: College of Dentistry, Qassim University
state: Qassim Region
Study officials:
affiliation: College of Dentistry, Qassim University, Saudi Arabia
name: Ghada A Khalifa, Professor
role: STUDY_DIRECTOR
References: