Dental AnxietyNCT06139640
The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children
A study testing Damask Rose Essential Oil in people with Dental Anxiety, run by Moushtaha Sayed Hamid.
Trial summary
This study aims to Evaluate and compare the role of Damask rose essential oils in reducing a child's dental anxiety and pain undergoing local anesthesia administration Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Damask Rose Essential Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Egyptian children from 7 to 12 years old require local anesthesia administration.
- 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 Mohammed contact
About this study
Official title: The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children Undergoing Local Anesthesia: A Randomized Clinical Trial
This study aims to Evaluate and compare the role of Damask rose essential oils in reducing a child's dental anxiety and pain undergoing local anesthesia administration
Read the detailed description
Dental anxiety is recognized as one of the major public health problems. It can lead to avoidance of necessary dental care, which affects oral health negatively, especially in children where dental care providers face a challenge to control dental anxiety to manage the child in the dental visit. Overall prevalence of dental anxiety was 23.9% with less prevalent in adolescents (13.3%), more prevalent in preschoolers (36.5%), and schoolchildren (25.8%).
Methods for managing anxiety in dentistry are both pharmacological and non-pharmacological. Aromatherapy is one of the non-pharmacological methods, it is a Simple, inexpensive, non-invasive method introduced by the use of aromatic essential oils through the sense of smell to produce positive physiological effects, relaxation and relieve anxiety symptoms. Aromatherapy can also decrease pain perception during local anesthetic injections in children.
Rosa damascene is commonly known as Damask roses, a plant belonging to the Rosaceae family. The flowers of this plant are large, showy and colorful. for its scent, it is also used in the production of essential oil and rose water. The R. damascena plant has also been used for medicinal applications it has analgesic, anti-inflammatory, anti-headache, and muscle-relaxing effects, and due to its strong depressing effect on the central nervous system it has hypnotic, anticonvulsant, antidepressant, and ant anxiety, effects.
The effect of rose oil in reducing pain has been conducted in children who are hospitalized for surgery, measuring the effect on post-operative pain intensity. Also, the effect of rose oil in the reduction of dental anxiety has already been studied but has been conducted on adults orthodontic patients.
- Conditions
- Dental Anxiety
- Being tested
- Damask Rose Essential Oil
- Keywords
- Aromatherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damask Rose Essential OilOther
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 rose oil on pain and anxiety level on pediatric dental patient | Active comparator | Rose oil aromatherapy Receives: Other: Damask Rose Essential Oil |
| The effects of no treatment on pain and anxiety level on pediatric dental patient | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse rate
will be recorded by an Automated blood pressure device
Measured: immediately after the intervention
Secondary outcomes (3)
Level of anxiety
will be recorded by Dental Anxiety Scale - Faces version [16] Modified Child Dental Anxiety Scale simplified Scores (1-5) higher scores mean worse outcome
Measured: immediately after the intervention
Blood pressure (systolic and diastolic blood pressure)
will be recorded by an Automated blood pressure device
Measured: immediately after the intervention
Pain rating scale
will be recorded by Faces, legs, activity, cry, and controllability scale (FLACC) Score(0-10) higher scores mean worse outcome
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 startOct 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moushtaha Sayed Hamid
- Sponsor type
- University, hospital or other
- Collaborators
- clinical professor
- Responsible party
- Sponsor-investigator, Moushtaha Sayed Hamid, Cairo University
- Investigators
- Kamal El-Motayam, Professor, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139640
- Sponsor's protocol ID
- Aromatherapy on Dental Anxiety
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 3 Jan 2024
- Results posted
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children Undergoing Local Anesthesia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06139640
- Acronym / sponsor ID
- Aromatherapy on Dental Anxiety
- Conditions
- Dental Anxiety
- Keywords
- Aromatherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Moushtaha Sayed HamidUniversity, hospital or other
- Collaborators
- clinical professor
- Study start
- Oct 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 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.
This study aims to Evaluate and compare the role of Damask rose essential oils in reducing a child's dental anxiety and pain undergoing local anesthesia administration
Detailed description
Dental anxiety is recognized as one of the major public health problems. It can lead to avoidance of necessary dental care, which affects oral health negatively, especially in children where dental care providers face a challenge to control dental anxiety to manage the child in the dental visit. Overall prevalence of dental anxiety was 23.9% with less prevalent in adolescents (13.3%), more prevalent in preschoolers (36.5%), and schoolchildren (25.8%).
Methods for managing anxiety in dentistry are both pharmacological and non-pharmacological. Aromatherapy is one of the non-pharmacological methods, it is a Simple, inexpensive, non-invasive method introduced by the use of aromatic essential oils through the sense of smell to produce positive physiological effects, relaxation and relieve anxiety symptoms. Aromatherapy can also decrease pain perception during local anesthetic injections in children.
Rosa damascene is commonly known as Damask roses, a plant belonging to the Rosaceae family. The flowers of this plant are large, showy and colorful. for its scent, it is also used in the production of essential oil and rose water. The R. damascena plant has also been used for medicinal applications it has analgesic, anti-inflammatory, anti-headache, and muscle-relaxing effects, and due to its strong depressing effect on the central nervous system it has hypnotic, anticonvulsant, antidepressant, and ant anxiety, effects.
The effect of rose oil in reducing pain has been conducted in children who are hospitalized for surgery, measuring the effect on post-operative pain intensity. Also, the effect of rose oil in the reduction of dental anxiety has already been studied but has been conducted on adults orthodontic patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The effects of rose oil on pain and anxiety level on pediatric dental patient | Active comparator | Other: Damask Rose Essential OilRose oil aromatherapy |
| The effects of no treatment on pain and anxiety level on pediatric dental patient | No intervention | – |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Egyptian children from 7 to 12 years old require local anesthesia administration.
- 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 |
|---|---|---|
| Damask Rose Essential 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 rose oil on pain and anxiety level on pediatric dental patient |
Primary outcome
Pulse rate
Time frame: immediately after the intervention
will be recorded by an Automated blood pressure device
3 secondary outcomes
Level of anxiety
Time frame: immediately after the intervention
Blood pressure (systolic and diastolic blood pressure)
Time frame: immediately after the intervention
Pain rating scale
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 3 Jan 2024.
- 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 Mohammed contact
Kamal El-Motayam, Professor study director
Professor
Questions about this trial
What is this clinical trial studying?
A study testing Damask Rose Essential Oil in people with Dental Anxiety, run by Moushtaha Sayed Hamid.
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 3 Jan 2024. 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 Moushtaha Sayed (00201145932261, moushtaha.himaida@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse rate (time frame: immediately after the intervention). 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 3 Jan 2024.