Pain Perception: on Relationships Between Dental Anxiety and Olfaction

Dental Anxiety Clinical Trial

Official title:

Pain Perception: on Relationships Between Dental Anxiety and Olfaction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05369936
• Other study ID #: EA/3006/20018
• Status: Completed
• Phase: N/A
• Start date: March 12, 2018
• Est. completion date: January 30, 2021

Study information

• Verified date: May 2022
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 30, 2021
• Est. primary completion date: April 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Dental Anxiety
• Dental Pain
• Essential Oil
• Toothache

Intervention

Other:
• Aromatherapy
Lavender will be inhaled through three phases
• Placebo
Vapors of the distal water will be inhaled through three phases

Locations

Country	Name	City	State
Saudi Arabia	Ghada Amin Khalifa	Buraidah	Buraydah

Sponsors (1)

Lead Sponsor	Collaborator
Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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