The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children

The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children Undergoing Local Anesthesia: A Randomized Clinical Trial

This study aims to Evaluate and compare the role of Damask rose essential oils in reducing a child's dental anxiety and pain undergoing local anesthesia administration

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Anxiety
• Intervention / Treatment: Other: Damask Rose Essential Oil

Detailed Description

Dental anxiety is recognized as one of the major public health problems. It can lead to avoidance of necessary dental care, which affects oral health negatively, especially in children where dental care providers face a challenge to control dental anxiety to manage the child in the dental visit. Overall prevalence of dental anxiety was 23.9% with less prevalent in adolescents (13.3%), more prevalent in preschoolers (36.5%), and schoolchildren (25.8%).

Methods for managing anxiety in dentistry are both pharmacological and non-pharmacological. Aromatherapy is one of the non-pharmacological methods, it is a Simple, inexpensive, non-invasive method introduced by the use of aromatic essential oils through the sense of smell to produce positive physiological effects, relaxation and relieve anxiety symptoms. Aromatherapy can also decrease pain perception during local anesthetic injections in children.

Rosa damascene is commonly known as Damask roses, a plant belonging to the Rosaceae family. The flowers of this plant are large, showy and colorful. for its scent, it is also used in the production of essential oil and rose water. The R. damascena plant has also been used for medicinal applications it has analgesic, anti-inflammatory, anti-headache, and muscle-relaxing effects, and due to its strong depressing effect on the central nervous system it has hypnotic, anticonvulsant, antidepressant, and ant anxiety, effects.

The effect of rose oil in reducing pain has been conducted in children who are hospitalized for surgery, measuring the effect on post-operative pain intensity. Also, the effect of rose oil in the reduction of dental anxiety has already been studied but has been conducted on adults orthodontic patients.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moushtaha Sayed; Phone Number: 00201145932261; Email: moushtaha.himaida@dentistry.cu.edu.eg
• Study Contact Backup: Name: Reem Mohammed; Email: reem.wahby@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Egyptian children from 7 to 12 years old require local anesthesia administration.
• Absence of any systemic problems, physical and mental disabilities.
• Children intellectually sufficient to complete the anxiety scale and those whose parents were willing to participate in the study.
• Frankel rating 3 in cooperation

Exclusion Criteria:

• Presence of dental or medical emergency and systemic disorders.
• Special needs children.
• Children with any respiratory tract illnesses, common, cold or allergy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The effects of rose oil on pain and anxiety level on pediatric dental patient; Rose oil aromatherapy	Other: Damask Rose Essential Oil; Aromatherapy is a relaxation therapy media that uses aromatic essence extracts from plant parts. Aromatherapy is used to treat and improve physical and psychological health
No Intervention: The effects of no treatment on pain and anxiety level on pediatric dental patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse rate	will be recorded by an Automated blood pressure device	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of anxiety	will be recorded by Dental Anxiety Scale - Faces version [16] Modified Child Dental Anxiety Scale simplified Scores (1-5) higher scores mean worse outcome	immediately after the intervention
Blood pressure (systolic and diastolic blood pressure)	will be recorded by an Automated blood pressure device	immediately after the intervention
Pain rating scale	will be recorded by Faces, legs, activity, cry, and controllability scale (FLACC) Score(0-10) higher scores mean worse outcome	immediately after the intervention

Collaborators and Investigators

• Sponsor: Moushtaha Sayed Hamid
• Collaborators: clinical professor
• Investigators: Study Director: Kamal El-Motayam, Professor, Professor

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 14, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Aromatherapy
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Aromatherapy on Dental Anxiety

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