Back to resultsPain Perception: on Relationships Between Dental Anxiety and Olfaction
Primary Purpose
Dental Anxiety, Dental Pain, Essential Oil
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Aromatherapy
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Dental Anxiety focused on measuring Dental Anxiety, Dental Pain, Emotional changes, Olfaction, Essential Oil, Lavender
Eligibility Criteria
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
Sites / Locations
- Ghada Amin Khalifa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lavender group
Placebo group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05369936
Brief Title
Pain Perception: on Relationships Between Dental Anxiety and Olfaction
Official Title
Pain Perception: on Relationships Between Dental Anxiety and Olfaction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
April 25, 2020 (Actual)
Study Completion Date
January 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety, Dental Pain, Essential Oil
Keywords
Dental Anxiety, Dental Pain, Emotional changes, Olfaction, Essential Oil, Lavender
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lavender group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Aromatherapy
Other Intervention Name(s)
Lavender
Intervention Description
Lavender will be inhaled through three phases
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Plain distal water
Intervention Description
Vapors of the distal water will be inhaled through three phases
Primary Outcome Measure Information:
Title
Anxiety score
Description
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
Time Frame
20 minutes before exposure to vapors
Title
Anxiety score
Description
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
Time Frame
20 minutes After exposure to vapors
Title
Anxiety score
Description
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
Time Frame
24 hours After exposure to vapors
Secondary Outcome Measure Information:
Title
Pain Score
Description
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
Time Frame
20 minutes before exposure to vapors
Title
Pain Score
Description
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
Time Frame
20 minutes after exposure to vapors
Title
Pain Score
Description
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
Time Frame
24 hours after exposure to vapors
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pain perception and anxiety is affected by gender. More common and exaggerated in females more than males
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah AM Alkanan, Resident
Organizational Affiliation
Qusaiba Hospital, Qassim, Saudi Arabia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hadeel S Alhaweri, Resident
Organizational Affiliation
Aljarirr Alshamali primary health care center, Qassim, Saudi Arabia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ghada A Khalifa, Professor
Organizational Affiliation
College of Dentistry, Qassim University, Saudi Arabia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shaimaa MS Ata, Lecturer
Organizational Affiliation
College of Dentistry, Qassim University, Saudi Arabia
Official's Role
Study Chair
Facility Information:
Facility Name
Ghada Amin Khalifa
City
Buraidah
State/Province
Buraydah
ZIP/Postal Code
51452
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
According to our authority regulations. It is not accepted to share date with other researchers
Learn more about this trial
Pain Perception: on Relationships Between Dental Anxiety and Olfaction
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