Clinical trial NCT06139640: The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children
Official title: The Effect of Damask Rose Essential Oil Aromatherapy on Dental Anxiety and Pain on Children Undergoing Local Anesthesia: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Anxiety
Keywords: Aromatherapy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: clinical professor
First posted: 2023-11-18
Enrollment: 46
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Pulse rate
timeFrame: immediately after the intervention
Secondary outcomes:
measure: Level of anxiety
timeFrame: immediately after the intervention
measure: Blood pressure (systolic and diastolic blood pressure)
timeFrame: immediately after the intervention
measure: Pain rating scale
timeFrame: immediately after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Kamal El-Motayam, Professor
role: STUDY_DIRECTOR
References: