Dental AnxietyNCT04115891
Lavender Oil Inhalation Help to Overcome Dental Anxiety Among Children
A study testing Anxiety scale, Pain scale - 1 and Pain scale - 2 in people with Dental Anxiety and Anxiety Disorder, run by Recep Tayyip Erdogan University Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Anxiety Disorder, Aromatherapy
- What is being tested?
- Anxiety scale, Pain scale - 1 and Pain scale - 2
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 30 Sep 2019
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being between 6 and 12 years of age
- children who are determined as Frankl 2, 3 or 4
- intellectually sufficient to complete the anxiety scale
- volunteer to take part in the study
- whose parents were willing to participate into the study
Who cannot join
- aged under 6
- has cognitive, cooperation (i.ex. Frankl 1) or systemic problems
- common allergies or dental pain
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Nazife Begüm KARAN
Ankara, Merkez, 83TR2WATUF
Nazife Begüm KARAN
Rize, Merkez, 053100
About this study
Official title: Can Lavender Oil Inhalation Help to Overcome Dental Anxiety and Pain in Children? A Randomized Clinical Trial
The purpose of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention.
Read the detailed description
Lavender oil has sedative properties. Dental anxiety is one of the most common obstacles to dental care, especially for children ranges from 3% to 43% in different populations. To the best of our knowledge, this is the first study to investigate the use of lavender oil inhalation and to assess the correlation of anxiety and vital signs among children during a stressful surgical dental intervention. This study design was constructed according to the vital sign evaluations, anxiety and pain scores. Primary hypothesis was that of lavender oil inhalation prior to surgical dental interventions would affect vital signs and consequently reduce anxiety and perception of pain in children.
- Conditions
- Dental Anxiety, Anxiety Disorder, Aromatherapy
- Being tested
- Anxiety scale, Pain scale - 1, Pain scale - 2, Inhalation
- 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.
Anxiety scaleOther
Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.
Pain scale - 1Other
Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction
Pain scale - 2Other
Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction
InhalationBehavioural
Also called 100 % pure, high strength lavender oil inhalation
lavender oil inhalation in a separate room for 3 minutes prior to interventions
| Study group | Role | What they receive |
|---|---|---|
| Lavender oil group | Experimental | 100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to tooth extractions.
Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale 2 (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation) Receives: Other: Anxiety scale; Other: Pain scale - 1; Other: Pain scale - 2; Behavioral: Inhalation |
| Control group | Sham comparator | No application prior to interventions. No lavender oil inhalation.
Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation) Receives: Other: Anxiety scale; Other: Pain scale - 1; Other: Pain scale - 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Sign Measurements - 1 (sistolic and diastolic blood pressure)
changes in systolic and diastolic blood pressure pre-operatively, intra-operatively, post-operatively
Measured: through study completion an average of 9 months
Vital Sign Measurements - 2 (heart rate)
changes in heart rate pre-operatively, intra-operatively, post-operatively
Measured: through study completion an average of 9 months
Vital Sign Measurements - 3 (saturation)
changes in saturation pre-operatively, intra-operatively, post-operatively
Measured: through study completion an average of 9 months
Secondary outcomes (3)
Anxiety Scale - Face Image Scale (FIS)
Five cartoon faces symbolized different emotions from very happy to very unhappy. The children chose one face at which they feel most like at that moment. One point is given to most positive face and 5 point is given to most negative face.
Measured: through study completion an average of 9 months
Pain Scale 1 - Face, Legs, Activity, Cry, Consolability (FLACC)
FLACC has five categories of behavior to rate pain as follows; facial expression, leg movement, activity, cry and consolability. The scores of each category are between 0 and 2. The total scores can change from 0 to 10 defined as mild (1-3), moderate (4-6) and severe (7-10).
Measured: through study completion an average of 9 months
Pain Scale 2 - Wong Baker Pain Rating Scales (WBS)
WBS combines pictures and numbers to rate pain. The scale has six faces assigned numerical ratings from 0 'no hurt' to 10 'hurts worst'. Administration of WBS is easy, not time consuming and requires minimal instructions
Measured: through study completion an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start1 Jan 2019
- Primary completion1 Sep 2019
- Study completion30 Sep 2019
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
- 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
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazife Begüm KARAN, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115891
- Sponsor's protocol ID
- 07
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Beginning 3 months and ending 5 years following article publication all data will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Lavender Oil Inhalation Help to Overcome Dental Anxiety and Pain in Children? A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04115891
- Acronym / sponsor ID
- 07
- Conditions
- Dental Anxiety, Anxiety Disorder, Aromatherapy
- Keywords
- lavandula, phytotherapy, aromatherapy, dental anxiety, anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 4 Oct 2019 (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 purpose of this study is to investigate the impact of lavender oil (Lavandula angustifolia) on anxiety, pain and vital signs (blood pressure, heart rate and saturation) among children planned to undergone surgical intervention.
Detailed description
Lavender oil has sedative properties. Dental anxiety is one of the most common obstacles to dental care, especially for children ranges from 3% to 43% in different populations. To the best of our knowledge, this is the first study to investigate the use of lavender oil inhalation and to assess the correlation of anxiety and vital signs among children during a stressful surgical dental intervention. This study design was constructed according to the vital sign evaluations, anxiety and pain scores. Primary hypothesis was that of lavender oil inhalation prior to surgical dental interventions would affect vital signs and consequently reduce anxiety and perception of pain in children.
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 | Experimental | Other: Anxiety scale, Other: Pain scale - 1, Other: Pain scale - 2, Behavioral: Inhalation100 % pure, high strength lavender oil inhalation in a separate room for 3 minutes, prior to tooth extractions. Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale 2 (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation) |
| Control group | Sham comparator | Other: Anxiety scale, Other: Pain scale - 1, Other: Pain scale - 2No application prior to interventions. No lavender oil inhalation. Anxiety scale (FIS) Pain scale 1 (FLACC) Pain scale (WBS) Vital signs 1 (systolic and diastolic blood pressure) Vital signs 2 (heart rate) Vital signs 3 (saturation) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- being between 6 and 12 years of age
- children who are determined as Frankl 2, 3 or 4
- intellectually sufficient to complete the anxiety scale
- volunteer to take part in the study
- whose parents were willing to participate into the study
Key exclusion criteria (3 listed)
- aged under 6
- has cognitive, cooperation (i.ex. Frankl 1) or systemic problems
- common allergies or dental pain
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 |
|---|---|---|
| Anxiety scaleAnxiety Face Image Scale (FIS) assessment in a separate room with face to face interview. | Other | Control group, Lavender oil group |
| Pain scale - 1Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction | Other | Control group, Lavender oil group |
| Pain scale - 2Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction | Other | Control group, Lavender oil group |
| InhalationAlso: 100 % pure, high strength lavender oil inhalationlavender oil inhalation in a separate room for 3 minutes prior to interventions | Behavioural | Lavender oil group |
Primary outcome
Vital Sign Measurements - 1 (sistolic and diastolic blood pressure)
Time frame: through study completion an average of 9 months
changes in systolic and diastolic blood pressure pre-operatively, intra-operatively, post-operatively
Vital Sign Measurements - 2 (heart rate)
Time frame: through study completion an average of 9 months
changes in heart rate pre-operatively, intra-operatively, post-operatively
Vital Sign Measurements - 3 (saturation)
Time frame: through study completion an average of 9 months
changes in saturation pre-operatively, intra-operatively, post-operatively
3 secondary outcomes
Anxiety Scale - Face Image Scale (FIS)
Time frame: through study completion an average of 9 months
Pain Scale 1 - Face, Legs, Activity, Cry, Consolability (FLACC)
Time frame: through study completion an average of 9 months
Pain Scale 2 - Wong Baker Pain Rating Scales (WBS)
Time frame: through study completion an average of 9 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 8 Oct 2019.
- Individual participant dataSharing planned: Undecided. Beginning 3 months and ending 5 years following article publication all data will be shared 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety scale, Pain scale - 1 and Pain scale - 2 in people with Dental Anxiety and Anxiety Disorder, run by Recep Tayyip Erdogan University Training and Research Hospital at 2 sites 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 5 inclusion and 3 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (sistolic and diastolic blood pressure) (time frame: through study completion an average of 9 months). 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 8 Oct 2019.