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

NCT ID: NCT06139640

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2024-12-31

Brief Summary

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

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.

Conditions

Dental Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

The effects of rose oil on pain and anxiety level on pediatric dental patient

Rose oil aromatherapy

Group Type: ACTIVE_COMPARATOR

Damask Rose Essential Oil

Intervention Type: OTHER

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

The effects of no treatment on pain and anxiety level on pediatric dental patient

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

clinical professor

UNKNOWN

Sponsor Role: collaborator

Moushtaha Sayed Hamid

OTHER

Sponsor Role: lead

Responsible Party

Moushtaha Sayed Hamid

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kamal El-Motayam, Professor

Role: STUDY_DIRECTOR

Professor

Central Contacts

Moushtaha Sayed

Role: CONTACT

moushtaha.himaida@dentistry.cu.edu.eg

00201145932261

Reem Mohammed

Role: CONTACT

reem.wahby@dentistry.cu.edu.eg

Other Identifiers

Aromatherapy on Dental Anxiety

Identifier Type: -

Identifier Source: org_study_id