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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05369936
Other study ID # EA/3006/20018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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