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

NCT05759286 | Completed

• 1 other identifier: UDDS-Pedo-01-2023
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Anxiety

Keywords

aromatherapy; music; lavender; neroli; anxiety

Outcome Measures

Primary Outcomes (2)

• Self report anxiety assessment

  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

  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 Outcomes (4)

• change in diastolic blood pressure

  5 minutes before anesthesia/20 second after anesthesia

• change in systolic blood pressure

  5 minutes before anesthesia/20 second after anesthesia

• change in pulse rate

  5 minutes before anesthesia/20second after anesthesia

• change in O2 saturation

  5 minutes before anesthesia/20 second after anesthesia

Study Arms (4)

aromatherapy group

EXPERIMENTAL

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

music group

EXPERIMENTAL

children in this group will receive IANB injections by listening to music as background from a recorder.

Behavioral: Music

combination group music and aromatherapy

EXPERIMENTAL

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; Behavioral: Music

control group

OTHER

children in this group will receive IANB injections with behavioral management techniques l

Behavioral: Control

Interventions

Aromatherapy BEHAVIORAL

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

aromatherapy group; combination group music and aromatherapy

Music BEHAVIORAL

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

combination group music and aromatherapy; music group

Control BEHAVIORAL

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

Also known as: Placebo

control group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \) children with the mental or systematic disease
• \) with a history of allergy, asthma, or have influenza
• )having a hearing problem or refusing to listen to music

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

College of Dentistry

Damascus, Al-Mazzeh Saint, Damascus P.O.Box 3062, Syria

Location

Related Publications (9)

• Ainscough SL, Windsor L, Tahmassebi JF. A review of the effect of music on dental anxiety in children. Eur Arch Paediatr Dent. 2019 Feb;20(1):23-26. doi: 10.1007/s40368-018-0380-6. Epub 2018 Oct 29.

  PMID: 30374854 BACKGROUND

• Agatonovic-Kustrin S, Kustrin E, Gegechkori V, Morton DW. Anxiolytic Terpenoids and Aromatherapy for Anxiety and Depression. Adv Exp Med Biol. 2020;1260:283-296. doi: 10.1007/978-3-030-42667-5_11.

  PMID: 32304038 BACKGROUND

• Arslan I, Aydinoglu S, Karan NB. Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial. Eur J Pediatr. 2020 Jun;179(6):985-992. doi: 10.1007/s00431-020-03595-7. Epub 2020 Feb 6.

  PMID: 32030454 BACKGROUND

• Bradt J, Teague A. Music interventions for dental anxiety. Oral Dis. 2018 Apr;24(3):300-306. doi: 10.1111/odi.12615. Epub 2017 Jan 5.

  PMID: 27886431 BACKGROUND

• Grisolia BM, Dos Santos APP, Dhyppolito IM, Buchanan H, Hill K, Oliveira BH. Prevalence of dental anxiety in children and adolescents globally: A systematic review with meta-analyses. Int J Paediatr Dent. 2021 Mar;31(2):168-183. doi: 10.1111/ipd.12712. Epub 2020 Sep 9.

  PMID: 33245591 BACKGROUND

• Morgan AG, Rodd HD, Porritt JM, Baker SR, Creswell C, Newton T, Williams C, Marshman Z. Children's experiences of dental anxiety. Int J Paediatr Dent. 2017 Mar;27(2):87-97. doi: 10.1111/ipd.12238. Epub 2016 Jul 4.

  PMID: 27376925 BACKGROUND

• Zhang N, Yao L. Anxiolytic Effect of Essential Oils and Their Constituents: A Review. J Agric Food Chem. 2019 Dec 18;67(50):13790-13808. doi: 10.1021/acs.jafc.9b00433. Epub 2019 Jun 13.

  PMID: 31148444 BACKGROUND

• Suntar I, Khan H, Patel S, Celano R, Rastrelli L. An Overview on Citrus aurantium L.: Its Functions as Food Ingredient and Therapeutic Agent. Oxid Med Cell Longev. 2018 May 2;2018:7864269. doi: 10.1155/2018/7864269. eCollection 2018.

  PMID: 29854097 BACKGROUND

• Ota M, Sato N, Sone D, Ogura J, Kunugi H. (-)-Linalool influence on the cerebral blood flow in healthy male volunteers revealed by three-dimensional pseudo-continuous arterial spin labeling. Indian J Psychiatry. 2017 Apr-Jun;59(2):225-227. doi: 10.4103/psychiatry.IndianJPsychiatry_323_16.

  PMID: 28827872 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Aromatherapy; Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Chaza Kouchaji, Professor

  Supervisal

  STUDY DIRECTOR

• Rasha Al-khatib, professor

  Co- supervisal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 8, 2023
• Study Start: September 15, 2021
• Primary Completion: March 20, 2022
• Study Completion: June 20, 2023
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)