Pain Perception: on Relationships Between Dental Anxiety and Olfaction

Study Overview
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Brief Summary
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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
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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

Official Title
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Pain Perception: on Relationships Between Dental Anxiety and Olfaction

Conditions
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Dental Anxiety, Dental Pain, Essential Oil

Intervention / Treatment
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* Other: Aromatherapy
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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, or subgingival scaling Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavender group<br>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<br>* Lavender will be inhaled through three phases<br>* Other names: Lavender;|
| Placebo Comparator: Placebo group<br>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<br>* Vapors of the distal water will be inhaled through three phases<br>* Other names: Plain distal water;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Anxiety, Dental Pain, Emotional changes, Olfaction, Essential Oil, Lavender