Dental AnxietyNCT05369936
Pain Perception: on Relationships Between Dental Anxiety and Olfaction
A study testing Aromatherapy in people with Dental Anxiety and Dental Pain, run by Qassim University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 19 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Dental Pain, Essential Oil
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Mar 2018to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Dental Anxiety, Dental Pain, Essential Oil
- Being tested
- Aromatherapy, Placebo
- Keywords
- Dental Anxiety, Dental Pain, Emotional changes, Olfaction, Essential Oil, Lavender
- Medical subject headings
- Toothache, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Also called Lavender
Lavender will be inhaled through three phases
PlaceboOther
Also called Plain distal water
Vapors of the distal water will be inhaled through three phases
| Study group | Role | What they receive |
|---|---|---|
| Lavender group | Experimental | 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. Receives: Other: Aromatherapy |
| Placebo group | Placebo comparator | 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 24 hours After exposure to vapors
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 24 hours after exposure to vapors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start12 Mar 2018
- Primary completion25 Apr 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Khalifa, Qassim University
- Investigators
- Sarah AM Alkanan, Resident, Principal investigator, Qusaiba Hospital, Qassim, Saudi ArabiaHadeel S Alhaweri, Resident, Principal investigator, Aljarirr Alshamali primary health care center, Qassim, Saudi ArabiaGhada A Khalifa, Professor, Study director, College of Dentistry, Qassim University, Saudi ArabiaShaimaa MS Ata, Lecturer, Study chair, College of Dentistry, Qassim University, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369936
- Sponsor's protocol ID
- EA/3006/20018
- Status last verified
- May 2022
- First submitted
- 20 Dec 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to our authority regulations. It is not accepted to share date with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception: on Relationships Between Dental Anxiety and Olfaction
- ClinicalTrials.gov ID
- NCT05369936
- Acronym / sponsor ID
- EA/3006/20018
- Conditions
- Dental Anxiety, Dental Pain, Essential Oil
- Keywords
- Dental Anxiety, Dental Pain, Emotional changes, Olfaction, Essential Oil, Lavender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Lavender group | Experimental | Other: AromatherapyOn 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. |
| Placebo group | Placebo comparator | Other: PlaceboThe 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 |
Who may qualify
- Ages
- 19 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyAlso: LavenderLavender will be inhaled through three phases | Other | Lavender group |
| PlaceboAlso: Plain distal waterVapors of the distal water will be inhaled through three phases | Other | Placebo group |
Primary outcome
Anxiety score
Time frame: 20 minutes before 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
Anxiety score
Time frame: 20 minutes 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
Anxiety score
Time frame: 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
3 secondary outcomes
Pain Score
Time frame: 20 minutes before exposure to vapors
Pain Score
Time frame: 20 minutes after exposure to vapors
Pain Score
Time frame: 24 hours after exposure to vapors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: No. According to our authority regulations. It is not accepted to share date with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah AM Alkanan, Resident principal investigator
Qusaiba Hospital, Qassim, Saudi Arabia
Hadeel S Alhaweri, Resident principal investigator
Aljarirr Alshamali primary health care center, Qassim, Saudi Arabia
Ghada A Khalifa, Professor study director
College of Dentistry, Qassim University, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Dental Anxiety and Dental Pain, run by Qassim University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety score (time frame: 20 minutes before exposure to vapors). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.