Dental AnxietyNCT04285385
Aromatherapy With Lavender Essential Oil as a Complementary Treatment for the Control of Dental Anxiety
A study testing Lavender aromatherapy in people with Dental Anxiety, run by Universidad Autónoma Benito Juárez de Oaxaca.
Trial summary
Dental anxiety is a common problem in dental care, the aim of this protocol is to evaluate the effect of lavender for the control of anxiety during a surgical dental extraction. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Lavender aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to May 2020
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteer to take part in the study
- Healthy patients
- Patients signing the informed consent
- Patients who need surgical removal of third molars
Who cannot join
- Hypertensive patients
- Patients with nasal congestion problems
- Patients allergic to lavender.
- Patients under treatment with anti depressants
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Aromatherapy With Lavender Essential Oil as a Complementary Treatment for the Control of Dental Anxiety in Patients Requiring Third Molar Surgery of the "University Autonomus Benito Juarez of Oaxaca" UABJO School of Dentistry
Dental anxiety is a common problem in dental care, the aim of this protocol is to evaluate the effect of lavender for the control of anxiety during a surgical dental extraction.
- Conditions
- Dental Anxiety
- Being tested
- Lavender aromatherapy, Sham aromatherapy
- Keywords
- aromatherapy, lavender, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender aromatherapyOther
0.10 ml of lavender essential oil
Sham aromatherapyOther
0.10 ml of mineral oil
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy | Experimental | 0.10 ml of lavender essential oil 30 minutes prior surgery Receives: Other: Lavender aromatherapy |
| Sham Aromatherapy | Sham comparator | 0.10 ml mineral oil 30 minutes prior surgery Receives: Other: Sham aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corah
Corah's Dental Anxiety Scale (1-25). Non anxiety (0-8), moderate (9-12), high (13-14), severe (over 15)
Measured: 45 minutes before dental treatment
Cortisol
Salivary Cortisol Testing (ng/mL)
Measured: 5 minutes Before aromatherapy
Cortisol
Salivary Cortisol Testing (ng/mL)
Measured: 30 minutes after aromatherapy
Secondary outcomes (6)
Heart rate
The speed of the heartbeat measured by the number of contractions of the heart per minute
Measured: 5 minutes Before aromatherapy
Heart rate
The speed of the heartbeat measured by the number of contractions of the heart per minute
Measured: 30 minutes after aromatherapy
Respiratory rate
The number of breaths per minute.
Measured: 5 minutes Before aromatherapy
Respiratory rate
The number of breaths per minute.
Measured: 30 minutes after aromatherapy
Arterial pressure
The pressure of circulating blood on the walls of blood vessels. (mm/Hg) sphingomanometer OMRON model HEM-7114
Measured: 5 minutes Before aromatherapy
Arterial pressure
The pressure of circulating blood on the walls of blood vessels. (mm/Hg) sphingomanometer OMRON model HEM-7114
Measured: 30 minutes after aromatherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMay 2020 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma Benito Juárez de Oaxaca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liliana Argueta Figueroa, Universidad Autónoma Benito Juárez de Oaxaca
- Investigators
- Liliana Argueta-Figueroa, DMD PhD, Principal investigator, UABJO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285385
- Sponsor's protocol ID
- 19PEC001FO
- Status last verified
- Feb 2020
- First submitted
- 21 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Measures of cortisol, vital sign, Corah scale, sex and age.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy With Lavender Essential Oil as a Complementary Treatment for the Control of Dental Anxiety in Patients Requiring Third Molar Surgery of the "University Autonomus Benito Juarez of Oaxaca" UABJO School of Dentistry
- ClinicalTrials.gov ID
- NCT04285385
- Acronym / sponsor ID
- 19PEC001FO
- Conditions
- Dental Anxiety
- Keywords
- aromatherapy, lavender, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidad Autónoma Benito Juárez de OaxacaUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 26 Feb 2020 (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.
Dental anxiety is a common problem in dental care, the aim of this protocol is to evaluate the effect of lavender for the control of anxiety during a surgical dental extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Experimental | Other: Lavender aromatherapy0.10 ml of lavender essential oil 30 minutes prior surgery |
| Sham Aromatherapy | Sham comparator | Other: Sham aromatherapy0.10 ml mineral oil 30 minutes prior surgery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteer to take part in the study
- Healthy patients
- Patients signing the informed consent
- Patients who need surgical removal of third molars
Key exclusion criteria (4 listed)
- Hypertensive patients
- Patients with nasal congestion problems
- Patients allergic to lavender.
- Patients under treatment with anti depressants
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 |
|---|---|---|
| Lavender aromatherapy0.10 ml of lavender essential oil | Other | Aromatherapy |
| Sham aromatherapy0.10 ml of mineral oil | Other | Sham Aromatherapy |
Primary outcome
Corah
Time frame: 45 minutes before dental treatment
Corah's Dental Anxiety Scale (1-25). Non anxiety (0-8), moderate (9-12), high (13-14), severe (over 15)
Cortisol
Time frame: 5 minutes Before aromatherapy
Salivary Cortisol Testing (ng/mL)
Cortisol
Time frame: 30 minutes after aromatherapy
Salivary Cortisol Testing (ng/mL)
6 secondary outcomes
Heart rate
Time frame: 5 minutes Before aromatherapy
Heart rate
Time frame: 30 minutes after aromatherapy
Respiratory rate
Time frame: 5 minutes Before aromatherapy
Respiratory rate
Time frame: 30 minutes after aromatherapy
Arterial pressure
Time frame: 5 minutes Before aromatherapy
Arterial pressure
Time frame: 30 minutes after aromatherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: Yes. Measures of cortisol, vital sign, Corah scale, sex and age.
Related trials for Dental Anxiety
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Evaluating Operation Calm With Children, Parents, and Clinicians
Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
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Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children
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Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
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Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
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.
Liliana Argueta-Figueroa, DMD PhD principal investigator
UABJO
Questions about this trial
What is this clinical trial studying?
A study testing Lavender aromatherapy in people with Dental Anxiety, run by Universidad Autónoma Benito Juárez de Oaxaca.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rafael Torres, MD PhD ((52) (951) 1448276, rtorres.cat@uabjo.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corah (time frame: 45 minutes before dental treatment). 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 26 Feb 2020.