search
Back to results

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

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Aromatherapy
Music
Control
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety focused on measuring aromatherapy, music, lavender, neroli, anxiety

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

aromatherapy group

music group

combination group music and aromatherapy

control group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

change in diastolic blood pressure
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
change in systolic blood pressure
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
change in pulse rate
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
change in O2 saturation
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

Full Information

First Posted
February 8, 2023
Last Updated
October 6, 2023
Sponsor
Damascus University
search

1. Study Identification

Unique Protocol Identification Number
NCT05759286
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
March 20, 2022 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
Keywords
aromatherapy, music, lavender, neroli, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aromatherapy group
Arm Type
Experimental
Arm Description
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
Arm Title
music group
Arm Type
Experimental
Arm Description
children in this group will receive IANB injections by listening to music as background from a recorder.
Arm Title
combination group music and aromatherapy
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
children in this group will receive IANB injections with behavioral management techniques l
Intervention Type
Behavioral
Intervention Name(s)
Aromatherapy
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Control
Other Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Self report anxiety assessment
Description
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
Time Frame
directly 1second after anesthesia administration
Title
Observation pain assessment
Description
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
Time Frame
5 second from starting the anesthesia
Secondary Outcome Measure Information:
Title
change in diastolic blood pressure
Description
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
Time Frame
5 minutes before anesthesia/20 second after anesthesia
Title
change in systolic blood pressure
Description
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
Time Frame
5 minutes before anesthesia/20 second after anesthesia
Title
change in pulse rate
Description
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
Time Frame
5 minutes before anesthesia/20second after anesthesia
Title
change in O2 saturation
Description
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
Time Frame
5 minutes before anesthesia/20 second after anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chaza Kouchaji, Professor
Organizational Affiliation
Supervisal
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rasha Al-khatib, professor
Organizational Affiliation
Co- supervisal
Official's Role
Study Director
Facility Information:
Facility Name
College of Dentistry
City
Damascus
State/Province
Al-Mazzeh Saint
ZIP/Postal Code
Damascus P.O.Box 3062
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30374854
Citation
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.
Results Reference
background
PubMed Identifier
32304038
Citation
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.
Results Reference
background
PubMed Identifier
32030454
Citation
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.
Results Reference
background
PubMed Identifier
27886431
Citation
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.
Results Reference
background
PubMed Identifier
33245591
Citation
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.
Results Reference
background
PubMed Identifier
27376925
Citation
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.
Results Reference
background
PubMed Identifier
31148444
Citation
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.
Results Reference
background
PubMed Identifier
29854097
Citation
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.
Results Reference
background
PubMed Identifier
28827872
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs