Clinical trial NCT05759286: A Blend of Lavender-neroli Oils Aromatherapy and Music for Managing Anxiety in a Pediatric Patient
Official title: Effect of Aromatherapy Using Lavender- Neroli Oils Blend and Music in the Management of Dental Anxiety in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: aromatherapy
music
lavender
neroli
anxiety
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 108
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The study sample will be divided randomly into 4 groups, each group will contain 27 children who need treatment in mandibular teeth and require anesthesia with inferior alveolar nerve block which is considered a painful procedure.

In the aromatherapy group, 3 drops of lavender-Neroli will be applied to cotton balls, which will be placed in a box designed with 3D printing to be placed on the nasal mask that is similar to the one used when administering nitrous oxide, so that the child inhales the aroma of the essential oil through the nasal mask. The mask is applied 5 minutes before administering local anesthesia in order to allow the child to inhale the oil aroma prior to and during local anesthesia.

In the music group, the music will be played from the recorder prior to local anesthesia and during it, music will be chosen by the child from the cartoon movies/tv shows they watch so that it is from his environment and familiar to them.

In The third group, both music and aromatherapy will drive the anesthesia process.

In The control groups, the child will put on the same nasal mask without an aromatherapy box to obtain a placebo effect and then receive the anesthesia.

Detailed description: The sample of this study were children attending the department of pediatric dentistry faculty of dentistry, Damascus university, who need treatment in the mandibular teeth with an IANB injection After taking informed consent from the parent, the children were divided into 4 groups: aromatherapy intervention, music intervention, both aroma, and music intervention, and control groups

In the aromatherapy group:

firstly the essential oils were obtained from Biocham Natural Extracts co, Damascus, Syria(100%pure lavender (L.angustifolia), 100% pure Neroli (C. aranium)) and the main components of the oils were determined by gas chromatography, which was found to be 47% linalool acetate in lavender oil, and 37% linalool 9% limonene in Neroli oil Then A 15% lavender-Neroli oil was prepared by blending 2.3 ml lavender oil with 0.9 ml Neroli oil and diluting with grape seed oil to 20 ml which was done in the department of pharmacognosy, Faculty of pharmacy Damascus university In the dental treatment, A child will be allowed to inhale the aromatic scent of the oil blend through a cylindrical box which is 3D printed and contains cavities inside it and perforated from its upper and lower surface. It will be applied to the circular hole of the mask which is similar to the one that uses when supplying nitrous oxide. so that this box allows for safer aromatherapy, as it can be removed in the event of any allergy symptoms appearing on the child and provide him oxygen through the mask.

3 drops of 15%lavender-Neroli blend were poured on cotton balls and then put on the aroma box, the box then was placed on the mask which was applied to the child's nose, so that the child inhales the scent of the aromatic blend through the holes in the bottom of the box, which faces the child's nose.

The children were asked to inhale the aromatic oils blend 5 minutes before intervention and during needle insertion when administrating IANB injection.

In the music group:

The child asks to choose a song from their cartoons and program to make it familiar to them and desirable and then listen to it through a recorder So that the music is heard as a background in the environment surrounding the work to avoid isolating the child from his environment and the ability to continue audio communication between the doctor and the child.

The songs will play 5 minutes before and during needle administrating. In the combination group: aromatherapy and music were used above In the control group: the children who received IANB injection-s will be treated with child behavior management like tell-show-do and the nitrous oxide nasal mask was used without the box which was used to carry inside it the scent of the aromatic oils blend to obtain a placebo effect.

The child's anxiety level would be assessed through FLACC, Facial image scale, heart rate, systolic, Diastolic blood pressure, and respiratory saturation before and after injection.

The IANB injection was performed using a 27-gauge needle and a local anesthetic of 2% lidocaine with 1:100,000 epinephrine by one researcher.

Eligibility criteria: Inclusion Criteria:

* 1) 6-11 age children
* 2)children category 2,3 on Frankle behavior rating scale,
* 3) need treatment in mandibular molars to need anesthesia with IANB injection

Exclusion Criteria:

* 1) children with the mental or systematic disease
* 2) with a history of allergy, asthma, or have influenza
* 3)having a hearing problem or refusing to listen to music

Primary outcomes:
measure: Self report anxiety assessment
timeFrame: directly 1second after anesthesia administration
measure: Observation pain assessment
timeFrame: 5 second from starting the anesthesia
Secondary outcomes:
measure: change in diastolic blood pressure
timeFrame: 5 minutes before anesthesia/20 second after anesthesia
measure: change in systolic blood pressure
timeFrame: 5 minutes before anesthesia/20 second after anesthesia
measure: change in pulse rate
timeFrame: 5 minutes before anesthesia/20second after anesthesia
measure: change in O2 saturation
timeFrame: 5 minutes before anesthesia/20 second after anesthesia
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: College of Dentistry
state: Al-Mazzeh Saint
Study officials:
affiliation: Supervisal
name: Chaza Kouchaji, Professor
role: STUDY_DIRECTOR
affiliation: Co- supervisal
name: Rasha Al-khatib, professor
role: STUDY_DIRECTOR
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