Anxiety, DentalNCT06133868
The Efficacy of Lavender and Chamomile Essential Oils Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anesthesia Administration and Primary Tooth Extraction
A study testing Lavender and Chamomile Essential Oils in people with Anxiety, Dental, run by Cairo University.
Trial summary
The Efficacy of Lavender and Chamomile Essential Oils Inhalation in Management of Dental Anxiety in Children Undergoing Local Anesthesia Administration and Primary Tooth Extraction. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Dental
- What is being tested?
- Lavender and Chamomile Essential Oils
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Sep 2024
- 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
The inclusion criteria:
- Patients with primary a mandibular molar that needs to be extracted.
- Patients aged between 6 and 12 years.
- Patients in their first dental visit.
- Patients who are intellectually sufficient to complete the anxiety scale.
- Children category 2, 3, 4 according to the Frankl Behaviour Rating Scale.
- Patients whose parents were willing to participate in the study.
The exclusion criteria:
- Patients with common allergies; Paediatric dental local anaesthesia allergies should be excluded to prevent bad reactions. Dental professionals should know how to treat local anaesthetic side effects such allergic and toxic responses. Consider the patient's medical history and physical condition before choosing a local anaesthetic dose and type. Identifying latex allergy patients and avoiding latex-containing products during dental operations is also important. For paediatric dental operations to be safe and effective, individuals with dental local anaesthesia allergies must be excluded.
- Patients with respiratory tract infections or lung diseases; There is a potential increased susceptibility for paediatric patients to experience unfavourable respiratory tract effects following exposure to essential oils such as lavender and chamomile. The literature has demonstrated that upon inhalation, essential oils has the ability to effectively penetrate both the upper and lower regions of the respiratory tract
- Patients with systemic problems; Lavender and chamomile essential oils may cause side effects in children with systemic diseases including impaired immune systems or chronic illnesses. Epidemiological studies have revealed no link between lavender essential oils and endocrine disturbance in youngsters. Children routinely exposed to these essential oils have similar endocrine abnormalities as those who are not .
Trial locations and contacts
No sites are listed yet.
Reem wahby, phd contact
About this study
The Efficacy of Lavender and Chamomile Essential Oils Inhalation in Management of Dental Anxiety in Children Undergoing Local Anesthesia Administration and Primary Tooth Extraction.
Read the detailed description
Dental anxiety refers to an atypical and excessive fear of seeking dental care for preventative purposes or treatment, as well as an unreasonable level of anxiety in relation to dental operations. According to reports, dental anxiety frequently leads to elevated levels of caries and behavioral management difficulties in children. Furthermore, it has been observed that they exhibit impaired oral function and compromised oral esthetics. In the context of pediatric dentistry, several stimuli such as visual cues (e.g., needles), auditory cues (e.g., drilling sounds), olfactory cues (e.g., scents of cut dentin and eugenol), and tactile cues (e.g., high frequency vibrations) commonly contribute to the provoking of anxiety .
Aromatherapy is a form of complementary medicine where the use of essential oils has been found to contribute to the improvement of emotional well-being, the promotion of tranquillity, and the induction of relaxation in the human body . Aromatherapy has attracted interest in the dentistry area because to its alternative nature, since it is considered a possible method for preventative and analgesic purposes. This entails the application of vital aromatic compounds through the methods of inhalation, massage, or ingestion.
Lavender oil is widely recognized as a prominent fragrant oil within the field of aromatherapy, renowned for its anxiolytic properties The calming qualities of lavender oil have been historically acknowledged, making it a highly effective essential oil in the realm of aromatherapy. According to an article titled "Effect of Lavender Oil on Anxiety" it has been shown that lavender oil possesses stimulating properties on the parasympathetic system, leading to a subsequent decrease in both blood pressure and levels of anxiety. Multiple investigations have elucidated the existence of pharmacological actions with sedative properties, which exhibit dose-dependent characteristics. Furthermore, the incorporation of supplements exhibiting these benefits has recently been introduced into clinical practice .
Moreover, Kreidel et al., in 2021, suggested that lavender oil can be safely inhaled as a kind of aromatherapy, as no adverse effects have been reported. Therefore, the administration of lavender oil through inhalation is widely regarded as the most secure method among all available options. In their study. , it was determined that aromatherapy has the potential to serve as a non-aversive approach, wherein patients are exposed to pleasant aromas during dental procedures. Due to the favorable outcomes observed in medical contexts and among adult dental patients, a considerable number of dental professionals hold the belief that employing these methodologies could be efficacious in the treatment of children dental patients.
. Abd Alkhalek et al. (2023) examined the effects of lavender and orange essential oil inhalation on children's vital signs and anxiety during dental treatment. The study comprised 60 children who needed primary tooth extractions. Lavender, Orange, and Control oils were inhaled by the children. Before treatment, the patient's pulse, blood pressure, and oxygen saturation were checked. After the essential oil inhalation, anaesthetic, and extraction, measurements were taken. The Wong Baker Scale measured child anxiety. The Lavender and Orange groups showed a statistically significant reduction in anxiety levels after therapy, according to the Wong Packer Pain Scale. Heart rate and breathing rate also decreased. The experiments showed lavender outperformed orange.
Chamomile is a further medicinal plant employed in the practice of aromatherapy . Chamomile essential oil, derived from the herbaceous plant belonging to the Asteraceae family, is one of the several oils that can be effectively used in the practice of inhalation aromatherapy. Apigenin, a chemical included in chamomile, demonstrates the capacity to interact with gamma-aminobutyric acid (GABA) receptors, potentially resulting in sedative and anti-anxiety effects. Chamomile also functions by stimulating the release of cortisol, has been found to alleviate anxiety. Previous studies have investigated the effects of this essential oil in various therapeutic contexts. A recent investigation carried out by (Ebrahimi et al., 2022) revealed the potential advantages associated with the use of chamomile essential oil aromatherapy in the reduction of anxiety levels among individuals having esophagogastroduodenoscopy. Additionally, this intervention was found to alleviate sensations of sorrow and improve the quality of sleep experienced by these patients. Currently, there is a lack of scholarly investigation about the concurrent utilization of lavender and chamomile essential oils by inhalation and its effects on reducing anxiety and pain in the field of pediatric dentistry.
Interestingly; The guidelines set forth by the American Academy of Pediatric Dentistry (AAPD) in 2023 suggest the utilization of aromatherapy as a non-pharmacological approach for alleviating anxiety and pain. Recommendations for Oral Health Policies The concept of endorsements refers to the act of publicly expressing support or approval for a person, According to Resources (The Reference Manual of Pediatric Dentistry 2022-2023 Definitions Oral Health Policies Recommendations Endorsements Resources, n.d.), the effectiveness and analgesic properties of lavender and chamomile oils have been the subject of previous research; yet, the majority of studies have mostly focused on adult populations. To the best of our current understanding, this research represents the inaugural investigation into the utilization of lavender oil inhalation as a means to examine the potential relationship between anxiety levels and vital signs in youngsters undergoing a stressful surgical dental intervention
- Conditions
- Anxiety, Dental
- Being tested
- Lavender and Chamomile Essential Oils
- 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 and Chamomile Essential OilsDrug
essential oils
| Study group | Role | What they receive |
|---|---|---|
| Group I (Experimental group) Chamomile | Active comparator | - · Describing the method for the child to become familiar with
· The patient will inhale natural chamomile oil in a separate room prior to the intervention. Three drops (0.1 cc per drop) will be poured on a cotton roll, and patients will inhale the oil without skin contact for 3 min. Receives: Drug: Lavender and Chamomile Essential Oils |
| - Group II (Experimental group) Lavender | Active comparator | * Describing the method for the child to become familiar with.
* The patient will inhale natural lavender oil (100% pure Lavandula) in a separate room prior to the intervention. Three drops (0.1 cc per drop) of lavender oil will be poured on a cotton roll, and patients will inhale the oil without skin contact for 3 min Receives: Drug: Lavender and Chamomile Essential Oils |
| - Group III (Control group) Cotton with saline | Placebo comparator | * Describing the method for the child to become familiar with
* The patient will inhale a clear cotton roll with saline. Receives: Drug: Lavender and Chamomile Essential Oils |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Facial Image Scale (FIS) Score from (1-5) high score means worse outcome Score from (1-5) counting from left to right from 1 = not nervous at all to 5 = very very nervous
Measured: immediately after the intervention
pain
Faces, legs ,activity ,cry , and consolability Score (0-10) high score means worse outcome
Measured: immediately after the intervention
Secondary outcomes (3)
Blood pressure (BP)
Sphygmomanometer
mmHg
Measured: immediately after the intervention
Pulse rate
Manual Beat/min
Measured: immediately after the intervention
3. Oxygen saturation
Pulse oximeter Percentage (%)
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
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 Anxiety, DentalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- clinical professor
- Responsible party
- Principal investigator, Sara Ibrahim Mansour Elsherbini, Cairo University
- Investigators
- Adel Albardisy, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133868
- Sponsor's protocol ID
- Lavander vs chamomile
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ebrahimi H, Mardani A, Basirinezhad MH, Hamidzadeh A, Eskandari F. The effects of Lavender and Chamomile essential oil inhalation aromatherapy on depression, anxiety and stress in older community-dwelling people: A randomized controlled trial. Explore (NY). 2022 May-Jun;18(3):272-278. doi: 10.1016/j.explore.2020.12.012. Epub 2021 Jan 9.
PubMed 33454232
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Lavender and Chamomile Essential Oils Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anesthesia Administration and Primary Tooth Extraction
- ClinicalTrials.gov ID
- NCT06133868
- Acronym / sponsor ID
- Lavander vs chamomile
- Conditions
- Anxiety, Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- clinical professor
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 18 Nov 2023 (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 Efficacy of Lavender and Chamomile Essential Oils Inhalation in Management of Dental Anxiety in Children Undergoing Local Anesthesia Administration and Primary Tooth Extraction.
Detailed description
Dental anxiety refers to an atypical and excessive fear of seeking dental care for preventative purposes or treatment, as well as an unreasonable level of anxiety in relation to dental operations. According to reports, dental anxiety frequently leads to elevated levels of caries and behavioral management difficulties in children. Furthermore, it has been observed that they exhibit impaired oral function and compromised oral esthetics. In the context of pediatric dentistry, several stimuli such as visual cues (e.g., needles), auditory cues (e.g., drilling sounds), olfactory cues (e.g., scents of cut dentin and eugenol), and tactile cues (e.g., high frequency vibrations) commonly contribute to the provoking of anxiety .
Aromatherapy is a form of complementary medicine where the use of essential oils has been found to contribute to the improvement of emotional well-being, the promotion of tranquillity, and the induction of relaxation in the human body . Aromatherapy has attracted interest in the dentistry area because to its alternative nature, since it is considered a possible method for preventative and analgesic purposes. This entails the application of vital aromatic compounds through the methods of inhalation, massage, or ingestion.
Lavender oil is widely recognized as a prominent fragrant oil within the field of aromatherapy, renowned for its anxiolytic properties The calming qualities of lavender oil have been historically acknowledged, making it a highly effective essential oil in the realm of aromatherapy. According to an article titled "Effect of Lavender Oil on Anxiety" it has been shown that lavender oil possesses stimulating properties on the parasympathetic system, leading to a subsequent decrease in both blood pressure and levels of anxiety. Multiple investigations have elucidated the existence of pharmacological actions with sedative properties, which exhibit dose-dependent characteristics. Furthermore, the incorporation of supplements exhibiting these benefits has recently been introduced into clinical practice .
Moreover, Kreidel et al., in 2021, suggested that lavender oil can be safely inhaled as a kind of aromatherapy, as no adverse effects have been reported. Therefore, the administration of lavender oil through inhalation is widely regarded as the most secure method among all available options. In their study. , it was determined that aromatherapy has the potential to serve as a non-aversive approach, wherein patients are exposed to pleasant aromas during dental procedures. Due to the favorable outcomes observed in medical contexts and among adult dental patients, a considerable number of dental professionals hold the belief that employing these methodologies could be efficacious in the treatment of children dental patients.
. Abd Alkhalek et al. (2023) examined the effects of lavender and orange essential oil inhalation on children's vital signs and anxiety during dental treatment. The study comprised 60 children who needed primary tooth extractions. Lavender, Orange, and Control oils were inhaled by the children. Before treatment, the patient's pulse, blood pressure, and oxygen saturation were checked. After the essential oil inhalation, anaesthetic, and extraction, measurements were taken. The Wong Baker Scale measured child anxiety. The Lavender and Orange groups showed a statistically significant reduction in anxiety levels after therapy, according to the Wong Packer Pain Scale. Heart rate and breathing rate also decreased. The experiments showed lavender outperformed orange.
Chamomile is a further medicinal plant employed in the practice of aromatherapy . Chamomile essential oil, derived from the herbaceous plant belonging to the Asteraceae family, is one of the several oils that can be effectively used in the practice of inhalation aromatherapy. Apigenin, a chemical included in chamomile, demonstrates the capacity to interact with gamma-aminobutyric acid (GABA) receptors, potentially resulting in sedative and anti-anxiety effects. Chamomile also functions by stimulating the release of cortisol, has been found to alleviate anxiety. Previous studies have investigated the effects of this essential oil in various therapeutic contexts. A recent investigation carried out by (Ebrahimi et al., 2022) revealed the potential advantages associated with the use of chamomile essential oil aromatherapy in the reduction of anxiety levels among individuals having esophagogastroduodenoscopy. Additionally, this intervention was found to alleviate sensations of sorrow and improve the quality of sleep experienced by these patients. Currently, there is a lack of scholarly investigation about the concurrent utilization of lavender and chamomile essential oils by inhalation and its effects on reducing anxiety and pain in the field of pediatric dentistry.
Interestingly; The guidelines set forth by the American Academy of Pediatric Dentistry (AAPD) in 2023 suggest the utilization of aromatherapy as a non-pharmacological approach for alleviating anxiety and pain. Recommendations for Oral Health Policies The concept of endorsements refers to the act of publicly expressing support or approval for a person, According to Resources (The Reference Manual of Pediatric Dentistry 2022-2023 Definitions Oral Health Policies Recommendations Endorsements Resources, n.d.), the effectiveness and analgesic properties of lavender and chamomile oils have been the subject of previous research; yet, the majority of studies have mostly focused on adult populations. To the best of our current understanding, this research represents the inaugural investigation into the utilization of lavender oil inhalation as a means to examine the potential relationship between anxiety levels and vital signs in youngsters undergoing a stressful surgical dental intervention
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Experimental group) Chamomile | Active comparator | Drug: Lavender and Chamomile Essential Oils- · Describing the method for the child to become familiar with · The patient will inhale natural chamomile oil in a separate room prior to the intervention. Three drops (0.1 cc per drop) will be poured on a cotton roll, and patients will inhale the oil without skin contact for 3 min. |
| - Group II (Experimental group) Lavender | Active comparator | Drug: Lavender and Chamomile Essential Oils* Describing the method for the child to become familiar with. * The patient will inhale natural lavender oil (100% pure Lavandula) in a separate room prior to the intervention. Three drops (0.1 cc per drop) of lavender oil will be poured on a cotton roll, and patients will inhale the oil without skin contact for 3 min |
| - Group III (Control group) Cotton with saline | Placebo comparator | Drug: Lavender and Chamomile Essential Oils* Describing the method for the child to become familiar with * The patient will inhale a clear cotton roll with saline. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 and Chamomile Essential Oilsessential oils | Drug | - Group II (Experimental group) Lavender, - Group III (Control group) Cotton with saline, Group I (Experimental group) Chamomile |
Primary outcome
Anxiety
Time frame: immediately after the intervention
Facial Image Scale (FIS) Score from (1-5) high score means worse outcome Score from (1-5) counting from left to right from 1 = not nervous at all to 5 = very very nervous
pain
Time frame: immediately after the intervention
Faces, legs ,activity ,cry , and consolability Score (0-10) high score means worse outcome
3 secondary outcomes
Blood pressure (BP)
Time frame: immediately after the intervention
Pulse rate
Time frame: immediately after the intervention
3. Oxygen saturation
Time frame: immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 33454232Ebrahimi H, Mardani A, Basirinezhad MH, Hamidzadeh A, Eskandari F. The effects of Lavender and Chamomile essential oil inhalation aromatherapy on depression, anxiety and stress in older community-dwelling people: A randomized controlled trial. Explore (NY). 2022 May-Jun;18(3):272-278. doi: 10.1016/j.explore.2020.12.012. Epub 2021 Jan 9.
- 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.
Reem wahby, phd contact
Adel Albardisy, professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Lavender and Chamomile Essential Oils in people with Anxiety, Dental, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 18 Nov 2023. 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 Sara Ibrahim El Sherbini, master (+201022922040, sara.mansour@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: immediately after the intervention). The study lists 2 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 NCT06133868, 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 18 Nov 2023.