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
1 other identifier
interventional
60
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedNovember 18, 2023
November 1, 2023
6 months
November 9, 2023
November 14, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
immediately after the intervention
pain
Faces, legs ,activity ,cry , and consolability Score (0-10) high score means worse outcome
immediately after the intervention
Secondary Outcomes (3)
Blood pressure (BP)
immediately after the intervention
Pulse rate
immediately after the intervention
3. Oxygen saturation
immediately after the intervention
Study Arms (3)
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.
- 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
- 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.
Interventions
essential oils
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- clinical professorcollaborator
Related Publications (1)
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.
PMID: 33454232BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adel Albardisy, professor
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
November 9, 2023
First Posted
November 18, 2023
Study Start
December 1, 2023
Primary Completion
June 1, 2024
Study Completion
September 1, 2024
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share