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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06139640
Other study ID # Aromatherapy on Dental Anxiety
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2024
Est. completion date December 2024

Study information

Verified date November 2023
Source Cairo University
Contact Moushtaha Sayed
Phone 00201145932261
Email moushtaha.himaida@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 46
Est. completion date December 2024
Est. primary completion date November 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Moushtaha Sayed Hamid clinical professor

Outcome

Type Measure Description Time frame Safety issue
Primary Pulse rate will be recorded by an Automated blood pressure device immediately after the intervention
Secondary 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
Secondary Blood pressure (systolic and diastolic blood pressure) will be recorded by an Automated blood pressure device immediately after the intervention
Secondary 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
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