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NCT Number: NCT06066073

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, Qassim University

Buraidah, Al-Qassim Region, 1162, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: Lavandula angustifolia.

Distal Water

Drug

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

Other names: Deionized water

Primary outcomes

  1. Anxiety score

    Time frame: 20 minutes after exposure

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

  2. Pain Score

    Time frame: 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."

Secondary outcomes

  1. Blood pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 4, 2023
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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