A Blend of Lavender-neroli Oils Aromatherapy and Music for Managing Anxiety in a Pediatric Patient

November 14, 2025 updated by: Damascus University

Effect of Aromatherapy Using Lavender- Neroli Oils Blend and Music in the Management of Dental Anxiety in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syria
    • Al-Mazzeh Saint
      • Damascus, Al-Mazzeh Saint, Syria, Damascus P.O.Box 3062
        • College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aromatherapy group
Children in this group will receive IANB injection with a nasal mask (similar to a nitrous oxide mask), the way the mask work is by putting on its circular hole a 3d printed perforated box containing cotton balls loaded with lavender-neroli oils blend
Behavioral: Aromatherapy
Aroma therapy will apply before 5 minutes and during IANB injection in children, aromatherapy will apply through a nasal mask similar to one that uses when applying nitrous oxide after putting a 3d printed perforated box on the mask's circular halo on its surface, in this box cotton bolls impregnated with 3 drops of a 15% lavender-neroli oils blend are placed and then the child will smell the scent of aromatic oil blend from the box's perforated bottom surface which faces child's nose
Experimental: music group
children in this group will receive IANB injections by listening to music as background from a recorder.
Behavioral: Music
Music will be played from a speaker in the treatment environment and will start 5 minutes before anesthesia and will be played through the whole anesthesia process, the music used will be chosen by the child from his favourite cartoon
Experimental: combination group music and aromatherapy
children in this group will receive aromatherapy using the nasal mask with an aromatherapy box as well as music for 5 minutes and through the injection
Behavioral: Aromatherapy
Aroma therapy will apply before 5 minutes and during IANB injection in children, aromatherapy will apply through a nasal mask similar to one that uses when applying nitrous oxide after putting a 3d printed perforated box on the mask's circular halo on its surface, in this box cotton bolls impregnated with 3 drops of a 15% lavender-neroli oils blend are placed and then the child will smell the scent of aromatic oil blend from the box's perforated bottom surface which faces child's nose
Behavioral: Music
Music will be played from a speaker in the treatment environment and will start 5 minutes before anesthesia and will be played through the whole anesthesia process, the music used will be chosen by the child from his favourite cartoon
Other: control group
children in this group will receive IANB injections with behavioral management techniques l
Behavioral: Control
using a tell-show-do approach and children will put on a nasal mask without the box that contains an aromatic oil blend for the placebo effect
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self report anxiety assessment
Time Frame: directly 1second after anesthesia administration
5 faces rang from very happy to very sad, one point is given to the most postive face and 5 point gives to the most negative face
directly 1second after anesthesia administration
Observation pain assessment
Time Frame: 5 second from starting the anesthesia
Face, Legs, Activity, Cry, Consolability(FLACC), it has five categories of behavior to assess pain, namely , facial expression, leg movement, activity, cry, and Consolability, the score of each category are between 0and 2, the total score can rang from 0 to 10, defined as mild(1-3), moderate (4-6), and severe (7-10). for each patient, FLACC would be assess through video recorded during administration the IANB injection and then were evaluated by an external evaluator to determine the children behavior score according to this scale
5 second from starting the anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in diastolic blood pressure
Time Frame: 5 minutes before anesthesia/20 second after anesthesia
digital blood pressure monitor will be placed in the child's left elbow and the difference between the reading 5 minutes before anesthesia and after 20 sec from it
5 minutes before anesthesia/20 second after anesthesia
change in systolic blood pressure
Time Frame: 5 minutes before anesthesia/20 second after anesthesia
digital blood pressure monitor will be placed in the child's left elbow and the difference between the reading 5 minutes before anesthesia and after 20 sec from it
5 minutes before anesthesia/20 second after anesthesia
change in pulse rate
Time Frame: 5 minutes before anesthesia/20second after anesthesia
an oximeter will be placed on the finger of the left hand and the difference between the pulse reading 5 minutes before anesthesia and 20 sec after it
5 minutes before anesthesia/20second after anesthesia
change in O2 saturation
Time Frame: 5 minutes before anesthesia/20 second after anesthesia
an oximeter will be placed on the finger of the left hand and the difference between the saturation reading 5 minutes before anesthesia and 20 sec after it
5 minutes before anesthesia/20 second after anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Director: Chaza Kouchaji, Professor, Supervisal
  • Study Director: Rasha Al-khatib, professor, Co- supervisal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

March 20, 2022

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 25, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Estimated)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-01-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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