Anxiety, DentalESAANCT05908981
The Effects of Sandalwood Aromatherapy on Anxiety Levels of Pediatric
A study testing sandalwood aromatherapy (Santalum album) in people with Anxiety, Dental, run by Aisha Mohammed Hamzi.
Trial summary
Aim of the study: Evaluate the anxiety in the child before treatment. Detection of the sandalwood and lavender oil effect on dental anxiety. 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?
- sandalwood aromatherapy (Santalum album)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Nov 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
Who may be able to join
- Egyptian children from 6 to 12 years old undergo primary tooth extraction.
- Absence of any systemic problems, physical and mental disabilities.
- Children intellectually sufficient to complete the anxiety scale and those whose parents were willing to participate in the study.
- Frankel rating 3 in cooperation.
Who cannot join
- Presence of dental or medical emergency and systemic disorders.
- Special needs children.
- Children with any respiratory tract illnesses, common cold, or allergy.
Trial locations and contacts
No sites are listed yet.
Reem wahby, phd contact
About this study
Official title: The Effects of Sandalwood Aromatherapy (Santalum Album) and Lavender Oil on Anxiety Levels of Pediatric Patients Undergoing Dental Extraction
Aim of the study:
Evaluate the anxiety in the child before treatment. Detection of the sandalwood and lavender oil effect on dental anxiety.
Read the detailed description
Anxiety is a kind of emotional disorder associated with unexpected or considered dangerous situations. Physiological signs that can be observed are sweating, increased blood pressure, tachycardia, dry mouth, diarrhea, muscle tension, and hyperventilation. The prevalence of anxiety for worldwide dental patients is considered high, reaching 6-15% of the population and usually starting from childhood (51%) and adolescents (22%). A study showed that 25% of primary-school-age children undergoing dental treatment experienced severe anxiety, 50% moderate anxiety, and 20% mild anxiety.
Aromatherapy is a relaxation therapy media that uses aromatic essence extracts from plant parts. Aromatherapy is used to treat and improve physical and psychological health. Aromatherapy essential oil stimulates receptors in the nose, then the information is transmitted further to areas in the brain that control emotions and provide information to the hypothalamus, which is a regulator of the internal system of the body so that it reacts to stress.
Sandalwood is one of 22 species of the genus Santalum in the world and is a commercial species through Santalol oil that is widely used as a feedstock for aromatherapy. Sandalwood has a distinctive aroma. This aroma comes from the main content of sandalwood, Santa lol. The quality of sandalwood oil is determined by the content of a-santalol and P-santalol. a-santalol and P-santalol are sesquiterpene organic compounds. Through aromatherapy, sandalwood oil is widely used to relieve anxiety, stress, and depression. This oil has neuroleptic, calming, and bronchial dilatation effects.
This study aims to analyze sandalwood aromatherapy's effect on the anxiety level of pediatric patients undergoing dental treatment. The analysis was seen through three indicators of anxiety, namely systolic blood pressure, diastolic blood pressure, and heart rate per minute.
- Conditions
- Anxiety, Dental
- Being tested
- sandalwood aromatherapy (Santalum album)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sandalwood aromatherapy (Santalum album)Other
Also called Lavender oil
Aromatherapy is a relaxation therapy media that uses aromatic essence extracts from plant parts. Aromatherapy is used to treat and improve physical and psychological health
| Study group | Role | What they receive |
|---|---|---|
| The effects of sandalwood oils on anxiety levels of pediatric | Active comparator | first group sandalwood aromatherapy Receives: Other: sandalwood aromatherapy (Santalum album) |
| The effects of Lavender oils on anxiety levels of pediatric | Active comparator | second group lavender oil Receives: Other: sandalwood aromatherapy (Santalum album) |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary outcome it is pulse rate for child undergoing extraction
It is measurement by Automated pressure device ((unit of M blood minute (1-5)
Measured: 3 month
Secondary outcomes (1)
Secondary outcome anxiety level of anxiety and blood pressure
measurement by Dental anxiety faces version ( MCDAS-simplified) scores from 1to 5 minimal it is 1 maximal it is 20 maximam it is wors Blood pressure measurement by Automated blood pressure device unit Millimetres of mercury
Measured: 3month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study startOct 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety, DentalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aisha Mohammed Hamzi
- Sponsor type
- University, hospital or other
- Collaborators
- clinical professor
- Responsible party
- Sponsor-investigator, Aisha Mohammed Hamzi, Cairo University
- Investigators
- Kamal El-Motayam, Professor, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908981
- Sponsor's protocol ID
- effects sandalwood on anxiety
- Acronym
- ESAA
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Mahendra, V. G., Dewi, A. M., Tedjosasongko, U., & Wibowo, T. B. (2020). The Effects of Sandalwood Aromatherapy (Santalum Album) and Bossa Nova Music on Anxiety Levels of Pediatric Patients Undergoing Topical Fluoride Treatment. European Journal of Molecular & Clinical Medicine, 7(5), 860-865.
Lakhan SE, Sheafer H, Tepper D. The Effectiveness of Aromatherapy in Reducing Pain: A Systematic Review and Meta-Analysis. Pain Res Treat. 2016;2016:8158693. doi: 10.1155/2016/8158693. Epub 2016 Dec 14.
PubMed 28070420
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sandalwood Aromatherapy (Santalum Album) and Lavender Oil on Anxiety Levels of Pediatric Patients Undergoing Dental Extraction
- ClinicalTrials.gov ID
- NCT05908981
- Acronym / sponsor ID
- ESAA / effects sandalwood on anxiety
- Conditions
- Anxiety, Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Aisha Mohammed HamziUniversity, hospital or other
- Collaborators
- clinical professor
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 18 Jun 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.
Aim of the study:
Evaluate the anxiety in the child before treatment. Detection of the sandalwood and lavender oil effect on dental anxiety.
Detailed description
Anxiety is a kind of emotional disorder associated with unexpected or considered dangerous situations. Physiological signs that can be observed are sweating, increased blood pressure, tachycardia, dry mouth, diarrhea, muscle tension, and hyperventilation. The prevalence of anxiety for worldwide dental patients is considered high, reaching 6-15% of the population and usually starting from childhood (51%) and adolescents (22%). A study showed that 25% of primary-school-age children undergoing dental treatment experienced severe anxiety, 50% moderate anxiety, and 20% mild anxiety.
Aromatherapy is a relaxation therapy media that uses aromatic essence extracts from plant parts. Aromatherapy is used to treat and improve physical and psychological health. Aromatherapy essential oil stimulates receptors in the nose, then the information is transmitted further to areas in the brain that control emotions and provide information to the hypothalamus, which is a regulator of the internal system of the body so that it reacts to stress.
Sandalwood is one of 22 species of the genus Santalum in the world and is a commercial species through Santalol oil that is widely used as a feedstock for aromatherapy. Sandalwood has a distinctive aroma. This aroma comes from the main content of sandalwood, Santa lol. The quality of sandalwood oil is determined by the content of a-santalol and P-santalol. a-santalol and P-santalol are sesquiterpene organic compounds. Through aromatherapy, sandalwood oil is widely used to relieve anxiety, stress, and depression. This oil has neuroleptic, calming, and bronchial dilatation effects.
This study aims to analyze sandalwood aromatherapy's effect on the anxiety level of pediatric patients undergoing dental treatment. The analysis was seen through three indicators of anxiety, namely systolic blood pressure, diastolic blood pressure, and heart rate per minute.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The effects of sandalwood oils on anxiety levels of pediatric | Active comparator | Other: sandalwood aromatherapy (Santalum album)first group sandalwood aromatherapy |
| The effects of Lavender oils on anxiety levels of pediatric | Active comparator | Other: sandalwood aromatherapy (Santalum album)second group lavender oil |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Egyptian children from 6 to 12 years old undergo primary tooth extraction.
- Absence of any systemic problems, physical and mental disabilities.
- Children intellectually sufficient to complete the anxiety scale and those whose parents were willing to participate in the study.
- Frankel rating 3 in cooperation.
Key exclusion criteria (3 listed)
- Presence of dental or medical emergency and systemic disorders.
- Special needs children.
- Children with any respiratory tract illnesses, common cold, or allergy.
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 |
|---|---|---|
| sandalwood aromatherapy (Santalum album)Also: Lavender oilAromatherapy is a relaxation therapy media that uses aromatic essence extracts from plant parts. Aromatherapy is used to treat and improve physical and psychological health | Other | The effects of Lavender oils on anxiety levels of pediatric, The effects of sandalwood oils on anxiety levels of pediatric |
Primary outcome
primary outcome it is pulse rate for child undergoing extraction
Time frame: 3 month
It is measurement by Automated pressure device ((unit of M blood minute (1-5)
1 secondary outcome
Secondary outcome anxiety level of anxiety and blood pressure
Time frame: 3month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Results publication1. Mahendra, V. G., Dewi, A. M., Tedjosasongko, U., & Wibowo, T. B. (2020). The Effects of Sandalwood Aromatherapy (Santalum Album) and Bossa Nova Music on Anxiety Levels of Pediatric Patients Undergoing Topical Fluoride Treatment. European Journal of Molecular & Clinical Medicine, 7(5), 860-865.
- Results publication: PubMed 28070420Lakhan SE, Sheafer H, Tepper D. The Effectiveness of Aromatherapy in Reducing Pain: A Systematic Review and Meta-Analysis. Pain Res Treat. 2016;2016:8158693. doi: 10.1155/2016/8158693. Epub 2016 Dec 14.
- 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
Kamal El-Motayam, Professor study director
Professor
Questions about this trial
What is this clinical trial studying?
A study testing sandalwood aromatherapy (Santalum album) in people with Anxiety, Dental, run by Aisha Mohammed Hamzi.
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 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: status not confirmed, as of the sponsor's last update on 18 Jun 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. 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 Aisha hamzi, mastar (96651430651, aisha.hamzi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary outcome it is pulse rate for child undergoing extraction (time frame: 3 month). 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 NCT05908981, which also lists 2 linked publications.
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 Jun 2023.