Pain Perception: on Relationships Between Dental Anxiety and Olfaction

Not Applicable

Completed

• Conditions: Dental Anxiety; Dental Pain; Essential Oil
• Interventions: Other: Placebo; Other: Aromatherapy

• Registration Number: NCT05369936
• Lead Sponsor: Qassim University

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.

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 Timeline

• Study Start: 2018-03-12
• Primary Completion: 2020-04-25
• Study Completion: 2021-01-30
• Study First Submitted: 2021-12-20
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-06
• Last Update Submitted: 2022-05-06
• Study First Posted: 2022-05-11
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	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
Lavender group	Aromatherapy	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.

Primary Outcome Measures

Name	Time	Method
Anxiety score	24 hours After exposure to vapors	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

Secondary Outcome Measures

Name	Time	Method
Pain Score	24 hours after exposure to vapors	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

Trial Locations

Locations (1)

Ghada Amin Khalifa; 🇸🇦 Buraidah, Buraydah, Saudi Arabia