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

NCT05759286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Dental Anxiety

Interventions

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

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

Sponsors & Collaborators

  • Damascus University

    lead OTHER

Principal Investigators

  • Chaza Kouchaji, Professor · Supervisal

  • Rasha Al-khatib, professor · Co- supervisal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-03-20
Completion
2023-06-20

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05759286 on ClinicalTrials.gov