Pain Perception: on Relationships Between Dental Anxiety and Olfaction

the objective of this study is to evaluate the ability of olfaction in obtaining positive emotional and behavioral responses toward dental anxiety and pain in patients undergoing different dental procedures.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Dental Pain; Essential Oil
• Intervention / Treatment: Other: Aromatherapy; Other: Placebo

Detailed Description

All patients who meet inclusion criteria of the study will be given a written consent and enrolled into a randomized double-blinded controlled study (investigator and patients are blinded about the study). Patients will be divided into lavender and control groups. Patients in lavender group will subjected 2 % lavender vapors. In control group, patients will inhale distal water vapors

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Buraydah
    • Buraidah, Buraydah, Saudi Arabia, 51452
      • Ghada Amin Khalifa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Adult females over 18 years,
2. Attending morning sessions of clinics (9 am)
3. Liable for administration of local anesthesia, tooth preparation either for filling procedures or crown preparations, endodontic treatment, teeth extraction, or subgingival scaling

Exclusion Criteria:

1. Males
2. Females who had allergies, bronchial asthma, common cold, pulmonary diseases, migraine, or taking antidepressants, anxiolytic drugs, opioids, or other medications that affect our results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lavender group; On the day of the lavender group, after filling the first phase questionnaire, 20 drops of the lavender oil will be added to the electrical aromatherapy vaporizer near the patient's chair at a distance of 20 cm in the waiting room. After 20 minutes, the second phase questionnaire will be given to the patient, and then the patient will be transformed to dental clinics in which the lavender vaporizer will be placed near the dental unit at a distance of 20 cm. The vaporizer will be also prepared by adding 20 drops of the lavender which will be added added every 20 minutes until the dental sitting will be finalized, and the third questionnaire will be answered. At home, the patients will be asked to pour 3 drops of the lavender on a pad and inhale it for 5 minutes from 10 cm distance every one hour until they attend on the next day to answer the fourth questionnaire.	Other: Aromatherapy; Lavender will be inhaled through three phases; Other Names: Lavender
Placebo Comparator: Placebo group; The plain distal water vapors will be used as placebo, the good ventilation of the waiting room and clinics will be performed to ensure that the lavender scent is completely removed from the environment. The patients will inhale the vapors of the plain distal water	Other: Placebo; Vapors of the distal water will be inhaled through three phases; Other Names: Plain distal water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety score	This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety	20 minutes before exposure to vapors
Anxiety score	This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety	20 minutes After exposure to vapors
Anxiety score	This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." GAD-7 total score for the seven items ranges from 0 to 21. 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety	24 hours After exposure to vapors

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	A person rates their pain on a scale of 0 to 10 Zero means "no pain," 1 to 3 means mild pin 4 to 6 means moderate pain 7 to 10 means severe pain	20 minutes before exposure to vapors
Pain Score	A person rates their pain on a scale of 0 to 10 Zero means "no pain," 1 to 3 means mild pin 4 to 6 means moderate pain 7 to 10 means severe pain	20 minutes after exposure to vapors
Pain Score	A person rates their pain on a scale of 0 to 10 Zero means "no pain," 1 to 3 means mild pin 4 to 6 means moderate pain 7 to 10 means severe pain	24 hours after exposure to vapors

Collaborators and Investigators

• Sponsor: Qassim University
• Investigators: Principal Investigator: Sarah AM Alkanan, Resident, Qusaiba Hospital, Qassim, Saudi Arabia; Principal Investigator: Hadeel S Alhaweri, Resident, Aljarirr Alshamali primary health care center, Qassim, Saudi Arabia; Study Director: Ghada A Khalifa, Professor, College of Dentistry, Qassim University, Saudi Arabia; Study Chair: Shaimaa MS Ata, Lecturer, College of Dentistry, Qassim University, Saudi Arabia

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2018
• Primary Completion (Actual): April 25, 2020
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Dental Anxiety; Dental Pain; Olfaction; Essential Oil; Emotional changes; Lavender
• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Anxiety Disorders; Toothache
• Other Study ID Numbers: EA/3006/20018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: According to our authority regulations. It is not accepted to share date with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No