Dental AnxietyNCT03722771
Influence of Lavender Oil on Vital Signs in Oral Surgery Patients
A study testing Inhalation, Anxiety Questionnaires 1 and Anxiety Questionnaires 2 in people with Dental Anxiety and Sedative; Anxiety Disorder, run by Nazife Begüm KARAN at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, mood, vital signs (blood pressure, respiratory rate, heart rate and saturation) for oral surgery patients. Read more about this study
- Who is it for?
- Ages 18 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Sedative; Anxiety Disorder
- What is being tested?
- Inhalation, Anxiety Questionnaires 1 and Anxiety Questionnaires 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 2 Nov 2018
- 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 37 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of wisdom tooth
- Must be similar in age-height-weight
- Must be similar socio-culturally
Who cannot join
- Under 18 years of age
- Taking psychotropic medication or psychiatric treatment
- Systemically unhealthy patients
- Pregnants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Lavender Oil on Vital Signs and Anxiety in Oral Surgery Patients: a Randomized Controlled Clinical Trial
The aim of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, mood, vital signs (blood pressure, respiratory rate, heart rate and saturation) for oral surgery patients.
Read the detailed description
Lavender oil has sedative properties. Oral surgical procedures have been proven as to be the greatest concern among dental practices for patients. Limited randomized clinical trials have demonstrated evidence-based results of lavender oil, despite being the most effective essential oil for anxiety and stress. The hypothesis of the present study was that the inhalation of lavender oil prior to oral surgical procedures may reduce anxiety and consequently may effect intra and post-operative blood pressure, inspiration and heart rate.
- Conditions
- Dental Anxiety, Sedative; Anxiety Disorder
- Being tested
- Inhalation, Anxiety Questionnaires 1, Anxiety Questionnaires 2, Vital Signs 1, Vital Signs 2
- Keywords
- Lavandula, phytotherapy, aromatherapy, dental anxiety, anaesthesia
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InhalationBehavioural
Also called lavender oil application
lavender oil inhalation in a separate room for 3 minutes prior to surgery
Anxiety Questionnaires 1Other
Also called Modified Dental Anxiety Scale
Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.
Anxiety Questionnaires 2Other
Also called State-Trait Anxiety Inventory-State Scale
State-Trait Anxiety Inventory-State Scale was used to distinguish the true anxiety level of the patients from the anxiety level for a particular situation.
Vital Signs 1Diagnostic test
Also called Blood Pressure
Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.
Vital Signs 2Diagnostic test
Also called Respiratory rate
Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.
Vital Signs 3Diagnostic test
Also called Heart rate
Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.
Vital Signs 4Diagnostic test
Also called Saturation
Changes in vital signs 4 - saturation - before, during and after the procedure were noted.
| Study group | Role | What they receive |
|---|---|---|
| lavender oil group (A) | Experimental | 100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to surgery.
Anxiety questionnaires 1 (MDAS) Anxiety questionnaires 2 (STAI-S) Vital signs 1 (Blood pressure) Vital signs 2 (respiratory rate,) Vital signs 3 (heart rate) Vital signs 4 (saturation) Receives: Behavioral: Inhalation; Other: Anxiety Questionnaires 1; Other: Anxiety Questionnaires 2; Diagnostic Test: Vital Signs 1; Diagnostic Test: Vital Signs 2; Diagnostic Test: Vital Signs 3; Diagnostic Test: Vital Signs 4 |
| control group (B) | Sham comparator | No application of lavender oil, prior to surgery. Anxiety questionnaires 1 (MDAS) Anxiety questionnaires 2 (STAI-S) Vital signs 1 (Blood pressure) Vital signs 2 (respiratory rate,) Vital signs 3 (heart rate) Vital signs 4 (saturation) Receives: Other: Anxiety Questionnaires 1; Other: Anxiety Questionnaires 2; Diagnostic Test: Vital Signs 1; Diagnostic Test: Vital Signs 2; Diagnostic Test: Vital Signs 3; Diagnostic Test: Vital Signs 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Sign Measurements - 1 - changes in blood pressure
changes in blood pressure
Measured: through study completion an average of 3 months
Vital Sign Measurements - 2 - changes in respiratory rate
changes in respiratory rate
Measured: through study completion an average of 3 months
Vital Sign Measurements - 3 - changes in heart rate
changes in heart rate
Measured: through study completion an average of 3 months
Vital Sign Measurements - 4 - changes in saturation level
changes in saturation level
Measured: through study completion an average of 3 months
Secondary outcomes (2)
Anxiety Test 1 - MDAS tests
MDAS tests
Measured: through study completion an average of 3 months
Anxiety Test 2 - STAI-S tests
STAI-S tests
Measured: through study completion an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Sep 2017
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nazife Begüm KARAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazife Begüm KARAN, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Nazife Begüm KARAN, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722771
- Sponsor's protocol ID
- 106
- Status last verified
- Jun 2020
- First submitted
- 22 Oct 2018
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karan NB. Influence of lavender oil inhalation on vital signs and anxiety: A randomized clinical trial. Physiol Behav. 2019 Nov 1;211:112676. doi: 10.1016/j.physbeh.2019.112676. Epub 2019 Sep 7.
PubMed 31505191
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lavender Oil on Vital Signs and Anxiety in Oral Surgery Patients: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03722771
- Acronym / sponsor ID
- 106
- Conditions
- Dental Anxiety, Sedative; Anxiety Disorder
- Keywords
- Lavandula, phytotherapy, aromatherapy, dental anxiety, anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Nazife Begüm KARANUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 29 Oct 2018 (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 aim of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, mood, vital signs (blood pressure, respiratory rate, heart rate and saturation) for oral surgery patients.
Detailed description
Lavender oil has sedative properties. Oral surgical procedures have been proven as to be the greatest concern among dental practices for patients. Limited randomized clinical trials have demonstrated evidence-based results of lavender oil, despite being the most effective essential oil for anxiety and stress. The hypothesis of the present study was that the inhalation of lavender oil prior to oral surgical procedures may reduce anxiety and consequently may effect intra and post-operative blood pressure, inspiration and heart rate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lavender oil group (A) | Experimental | Behavioral: Inhalation, Other: Anxiety Questionnaires 1, Other: Anxiety Questionnaires 2, Diagnostic Test: Vital Signs 1, Diagnostic Test: Vital Signs 2, Diagnostic Test: Vital Signs 3, Diagnostic Test: Vital Signs 4100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to surgery. Anxiety questionnaires 1 (MDAS) Anxiety questionnaires 2 (STAI-S) Vital signs 1 (Blood pressure) Vital signs 2 (respiratory rate,) Vital signs 3 (heart rate) Vital signs 4 (saturation) |
| control group (B) | Sham comparator | Other: Anxiety Questionnaires 1, Other: Anxiety Questionnaires 2, Diagnostic Test: Vital Signs 1, Diagnostic Test: Vital Signs 2, Diagnostic Test: Vital Signs 3, Diagnostic Test: Vital Signs 4No application of lavender oil, prior to surgery. Anxiety questionnaires 1 (MDAS) Anxiety questionnaires 2 (STAI-S) Vital signs 1 (Blood pressure) Vital signs 2 (respiratory rate,) Vital signs 3 (heart rate) Vital signs 4 (saturation) |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of wisdom tooth
- Must be similar in age-height-weight
- Must be similar socio-culturally
Key exclusion criteria (4 listed)
- Under 18 years of age
- Taking psychotropic medication or psychiatric treatment
- Systemically unhealthy patients
- Pregnants
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 |
|---|---|---|
| InhalationAlso: lavender oil applicationlavender oil inhalation in a separate room for 3 minutes prior to surgery | Behavioural | lavender oil group (A) |
| Anxiety Questionnaires 1Also: Modified Dental Anxiety ScaleModified Dental Anxiety Scale was used to describe the level of the dental anxiety. | Other | control group (B), lavender oil group (A) |
| Anxiety Questionnaires 2Also: State-Trait Anxiety Inventory-State ScaleState-Trait Anxiety Inventory-State Scale was used to distinguish the true anxiety level of the patients from the anxiety level for a particular situation. | Other | control group (B), lavender oil group (A) |
| Vital Signs 1Also: Blood PressureChanges in vital signs 1 - blood pressure - before, during and after the procedure were noted. | Diagnostic test | control group (B), lavender oil group (A) |
| Vital Signs 2Also: Respiratory rateChanges in vital signs 2 - respiratory rate - before, during and after the procedure were noted. | Diagnostic test | control group (B), lavender oil group (A) |
| Vital Signs 3Also: Heart rateChanges in vital signs 3 - heart rate - before, during and after the procedure were noted. | Diagnostic test | control group (B), lavender oil group (A) |
| Vital Signs 4Also: SaturationChanges in vital signs 4 - saturation - before, during and after the procedure were noted. | Diagnostic test | control group (B), lavender oil group (A) |
Primary outcome
Vital Sign Measurements - 1 - changes in blood pressure
Time frame: through study completion an average of 3 months
changes in blood pressure
Vital Sign Measurements - 2 - changes in respiratory rate
Time frame: through study completion an average of 3 months
changes in respiratory rate
Vital Sign Measurements - 3 - changes in heart rate
Time frame: through study completion an average of 3 months
changes in heart rate
Vital Sign Measurements - 4 - changes in saturation level
Time frame: through study completion an average of 3 months
changes in saturation level
2 secondary outcomes
Anxiety Test 1 - MDAS tests
Time frame: through study completion an average of 3 months
Anxiety Test 2 - STAI-S tests
Time frame: through study completion an average of 3 months
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 Jun 2020.
- Derived from this study: PubMed 31505191Karan NB. Influence of lavender oil inhalation on vital signs and anxiety: A randomized clinical trial. Physiol Behav. 2019 Nov 1;211:112676. doi: 10.1016/j.physbeh.2019.112676. Epub 2019 Sep 7.
- Individual participant dataSharing planned: No
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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.
Nazife Begüm KARAN principal investigator
Recep Tayyip Erdogan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhalation, Anxiety Questionnaires 1 and Anxiety Questionnaires 2 in people with Dental Anxiety and Sedative; Anxiety Disorder, run by Nazife Begüm KARAN at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 11 Jun 2020. 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 Turkey (Türkiye). 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?
Vital Sign Measurements - 1 - changes in blood pressure (time frame: through study completion an average of 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722771, which also lists 1 linked publication.
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 Jun 2020.