Clinical trial NCT05908981: The Effects of Sandalwood Aromatherapy on Anxiety Levels of Pediatric
Official title: The Effects of Sandalwood Aromatherapy (Santalum Album) and Lavender Oil on Anxiety Levels of Pediatric Patients Undergoing Dental Extraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety, Dental
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: clinical professor
First posted: 2023-06-18
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aim of the study:

Evaluate the anxiety in the child before treatment. Detection of the sandalwood and lavender oil effect on dental anxiety.

Detailed description: Anxiety is a kind of emotional disorder associated with unexpected or considered dangerous situations. Physiological signs that can be observed are sweating, increased blood pressure, tachycardia, dry mouth, diarrhea, muscle tension, and hyperventilation. The prevalence of anxiety for worldwide dental patients is considered high, reaching 6-15% of the population and usually starting from childhood (51%) and adolescents (22%). A study showed that 25% of primary-school-age children undergoing dental treatment experienced severe anxiety, 50% moderate anxiety, and 20% mild anxiety.

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. Aromatherapy essential oil stimulates receptors in the nose, then the information is transmitted further to areas in the brain that control emotions and provide information to the hypothalamus, which is a regulator of the internal system of the body so that it reacts to stress.

Sandalwood is one of 22 species of the genus Santalum in the world and is a commercial species through Santalol oil that is widely used as a feedstock for aromatherapy. Sandalwood has a distinctive aroma. This aroma comes from the main content of sandalwood, Santa lol. The quality of sandalwood oil is determined by the content of a-santalol and P-santalol. a-santalol and P-santalol are sesquiterpene organic compounds. Through aromatherapy, sandalwood oil is widely used to relieve anxiety, stress, and depression. This oil has neuroleptic, calming, and bronchial dilatation effects.

This study aims to analyze sandalwood aromatherapy's effect on the anxiety level of pediatric patients undergoing dental treatment. The analysis was seen through three indicators of anxiety, namely systolic blood pressure, diastolic blood pressure, and heart rate per minute.

Eligibility criteria: Inclusion Criteria:

1. Egyptian children from 6 to 12 years old undergo primary tooth extraction.
2. Absence of any systemic problems, physical and mental disabilities.
3. Children intellectually sufficient to complete the anxiety scale and those whose parents were willing to participate in the study.
4. Frankel rating 3 in cooperation.

Exclusion Criteria:

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

Primary outcomes:
measure: primary outcome it is pulse rate for child undergoing extraction
timeFrame: 3 month
Secondary outcomes:
measure: Secondary outcome anxiety level of anxiety and blood pressure
timeFrame: 3month
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Kamal El-Motayam, Professor
role: STUDY_DIRECTOR
References:
citation: 1. Mahendra, V. G., Dewi, A. M., Tedjosasongko, U., & Wibowo, T. B. (2020). The Effects of Sandalwood Aromatherapy (Santalum Album) and Bossa Nova Music on Anxiety Levels of Pediatric Patients Undergoing Topical Fluoride Treatment. European Journal of Molecular & Clinical Medicine, 7(5), 860-865.
citation: Lakhan SE, Sheafer H, Tepper D. The Effectiveness of Aromatherapy in Reducing Pain: A Systematic Review and Meta-Analysis. Pain Res Treat. 2016;2016:8158693. doi: 10.1155/2016/8158693. Epub 2016 Dec 14.