Pain Perception: on Relationships Between Dental Anxiety and Olfaction

NCT05369936 | Completed DMC

• 1 other identifier: EA/3006/20018
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety; Dental Pain; Essential Oil

Keywords

Dental Anxiety; Dental Pain; Emotional changes; Olfaction; Essential Oil; Lavender

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Pain Score

  20 minutes before exposure to vapors

• Pain Score

  20 minutes after exposure to vapors

• Pain Score

  24 hours after exposure to vapors

Study Arms (2)

Lavender group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Aromatherapy OTHER

Lavender will be inhaled through three phases

Also known as: Lavender

Lavender group

Placebo OTHER

Vapors of the distal water will be inhaled through three phases

Also known as: Plain distal water

Placebo group

Eligibility Criteria

• Age: 19 Years - 25 Years
• Gender Eligibility Details: Pain perception and anxiety is affected by gender. More common and exaggerated in females more than males
• 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, or subgingival scaling

You may not qualify if:

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

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

Ghada Amin Khalifa

Buraidah, Buraydah, 51452, Saudi Arabia

Location

MeSH Terms

Conditions

Toothache; Anosmia

Interventions

Aromatherapy; lavender oil

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Olfaction Disorders; Sensation Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sarah AM Alkanan, Resident

  Qusaiba Hospital, Qassim, Saudi Arabia

  PRINCIPAL INVESTIGATOR

• Hadeel S Alhaweri, Resident

  Aljarirr Alshamali primary health care center, Qassim, Saudi Arabia

  PRINCIPAL INVESTIGATOR

• Ghada A Khalifa, Professor

  College of Dentistry, Qassim University, Saudi Arabia

  STUDY DIRECTOR

• Shaimaa MS Ata, Lecturer

  College of Dentistry, Qassim University, Saudi Arabia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization will be performed according to patients' sequences where all odd numbers of patients will be incorporated into control group, while even numbers will be included in lavender group. The patients will not be informed about the type of the essential oil. T This was achieved by inserting lavender vaporizers in all setting rooms and clinics. So that the patients will believe that there is no extraordinary maneuver in the clinics. Also, all the dentists who treated the patients and evaluators who will interview the patients and questionnaires, will not be informed of the type of the essential oil which will be used. The statistician who will analyze the questionnaires will be informed that the study's groups are named as group A or B.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Maxillofacial Surgery and Diagnostic Science

Model Details: The patients will be divided into a control group in which the patients will be subjected to vapors of plain distal water, and lavender group where the patients will inhale vapors of the lavender oil to stimulate olfaction

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: May 11, 2022
• Study Start: March 12, 2018
• Primary Completion: April 25, 2020
• Study Completion: January 30, 2021
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)