Pain SyndromeNCT06068777
The Impact of Aromatherapy on Alleviating Dental Anxiety in Children
A study testing Rosmary and Lemongrass Oil in people with Pain Syndrome, run by Suez Canal University at 1 site in Egypt.
Trial summary
Dealing with dental anxiety in children is the most problematic responsibilities for pedodontists in the dental office. Essential oils had been used for reducing dental anxiety in adults; this study is a challenge to understand their effects on children. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Pain Syndrome
- What is being tested?
- Rosmary and Lemongrass Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Mar 2022to 21 Aug 2022
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged from six to nine years old
- Both girls and boys will be included.
- Patients who need extraction in at least one primary molar.
- Parents who will agree to contribute in the study.
- Patients with Frankl Behavior Rating Scale, categories 2, 3 and 4
Who cannot join
- Medically compromised patient
- Allergic children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scentsational Smiles: The Impact of Aromatherapy on Alleviating Dental Anxiety in Children
Dealing with dental anxiety in children is the most problematic responsibilities for pedodontists in the dental office. Essential oils had been used for reducing dental anxiety in adults; this study is a challenge to understand their effects on children. Aromatherapy is considered as a reasonable, potent, safe, and non-pharmacological way, which has been taken into consideration, especially for children who are supposed to go through any dental procedure under local anesthesia. The aim of this study is to explore and compare the effect of Rosemary versus Lemongrass essential oils on dental anxiety levels and vital signs of children during dental anesthesia and extraction of a lower primary molar in a dental office. Forty-five children, aged between 4 to 7 years, who had a minimum of one mandibular primary molar with deep caries indicated for extraction were selected. Patients are divided, randomly, into three groups (15 children each): Group I (control group): with no interference before dental anesthesia and extraction, Group II (Rosemary group): children inhaled two drops of rosemary oil for 3 minutes before the procedures of dental anesthesia and extraction of a primary molar, Group III (Lemongrass group): children inhaled two drops of lemongrass oil, for 3 minutes before the procedure of dental anesthesia and extraction of a primary molar. Wong Baker Scale and the physiological measures of the children's anxiety will be evaluated and recorded for each child by measuring (pulse rate, oxygen saturation, and blood pressure) before, during and after the dental procedures.
- Conditions
- Pain Syndrome
- Being tested
- Rosmary, Lemongrass Oil
- Medical subject headings
- Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosmaryDrug
inhale two drops of rosemary oil, from a gauze, for 3 minutes before the procedure of extraction of a primary molar
Lemongrass OilDrug
inhale two drops of lemongrass oil, from a gauze, for three minutes before the procedure of extraction.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | with no interference before dental anesthesia and extraction |
| Rosemary group | Active comparator | children inhaled two drops of rosemary oil for 3 minutes before the procedures of dental anesthesia and extraction of a primary molar, Receives: Drug: Rosmary |
| Lemongrass group | Active comparator | children inhaled two drops of lemongrass oil, for 3 minutes before the procedure of dental anesthesia and extraction of a primary molar Receives: Drug: Lemongrass Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring pulse rate " heart rate"
Measured: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
oxygen saturation
oxygen saturation using pulse oximeter.
Measured: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
blood pressure using a sphygmomanometer
systolic and diastolic blood pressure will be measured
Measured: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
pain level
the Wong-Baker Scale will be used where 0 no pain and 7 hurts worst
Measured: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start23 Mar 2022
- Primary completion23 Jul 2022
- Study completion21 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068777
- Sponsor's protocol ID
- 455/2022
- Status last verified
- Sep 2023
- First submitted
- 8 Jul 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scentsational Smiles: The Impact of Aromatherapy on Alleviating Dental Anxiety in Children
- ClinicalTrials.gov ID
- NCT06068777
- Acronym / sponsor ID
- 455/2022
- Conditions
- Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 23 Jul 2022 (actual)
- Study completion
- 21 Aug 2022 (actual)
- First posted
- 5 Oct 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.
Dealing with dental anxiety in children is the most problematic responsibilities for pedodontists in the dental office. Essential oils had been used for reducing dental anxiety in adults; this study is a challenge to understand their effects on children. Aromatherapy is considered as a reasonable, potent, safe, and non-pharmacological way, which has been taken into consideration, especially for children who are supposed to go through any dental procedure under local anesthesia. The aim of this study is to explore and compare the effect of Rosemary versus Lemongrass essential oils on dental anxiety levels and vital signs of children during dental anesthesia and extraction of a lower primary molar in a dental office. Forty-five children, aged between 4 to 7 years, who had a minimum of one mandibular primary molar with deep caries indicated for extraction were selected. Patients are divided, randomly, into three groups (15 children each): Group I (control group): with no interference before dental anesthesia and extraction, Group II (Rosemary group): children inhaled two drops of rosemary oil for 3 minutes before the procedures of dental anesthesia and extraction of a primary molar, Group III (Lemongrass group): children inhaled two drops of lemongrass oil, for 3 minutes before the procedure of dental anesthesia and extraction of a primary molar. Wong Baker Scale and the physiological measures of the children's anxiety will be evaluated and recorded for each child by measuring (pulse rate, oxygen saturation, and blood pressure) before, during and after the dental procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –with no interference before dental anesthesia and extraction |
| Rosemary group | Active comparator | Drug: Rosmarychildren inhaled two drops of rosemary oil for 3 minutes before the procedures of dental anesthesia and extraction of a primary molar, |
| Lemongrass group | Active comparator | Drug: Lemongrass Oilchildren inhaled two drops of lemongrass oil, for 3 minutes before the procedure of dental anesthesia and extraction of a primary molar |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients aged from six to nine years old
- Both girls and boys will be included.
- Patients who need extraction in at least one primary molar.
- Parents who will agree to contribute in the study.
- Patients with Frankl Behavior Rating Scale, categories 2, 3 and 4
Key exclusion criteria (2 listed)
- Medically compromised patient
- Allergic children
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 |
|---|---|---|
| Rosmaryinhale two drops of rosemary oil, from a gauze, for 3 minutes before the procedure of extraction of a primary molar | Drug | Rosemary group |
| Lemongrass Oilinhale two drops of lemongrass oil, from a gauze, for three minutes before the procedure of extraction. | Drug | Lemongrass group |
Primary outcome
measuring pulse rate " heart rate"
Time frame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
oxygen saturation
Time frame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
oxygen saturation using pulse oximeter.
blood pressure using a sphygmomanometer
Time frame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
systolic and diastolic blood pressure will be measured
pain level
Time frame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"
the Wong-Baker Scale will be used where 0 no pain and 7 hurts worst
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 5 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosmary and Lemongrass Oil in people with Pain Syndrome, run by Suez Canal University at 1 site in Egypt.
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 2 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 5 Oct 2023. 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 Egypt. 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. 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?
measuring pulse rate " heart rate" (time frame: baseline before procedure, during procedure "extraction" and immediately after procedure "extraction"). 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?
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 5 Oct 2023.