Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05908981
Other study ID # effects sandalwood on anxiety
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2024
Est. completion date November 2024

Study information

Verified date June 2023
Source Cairo University
Contact Aisha hamzi, mastar
Phone 96651430651
Email aisha.hamzi@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 78
Est. completion date November 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
sandalwood aromatherapy (Santalum album)
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
Aisha Mohammed Hamzi clinical professor

References & Publications (2)

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 Mol

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary primary outcome it is pulse rate for child undergoing extraction It is measurement by Automated pressure device ((unit of M blood minute (1-5) 3 month
Secondary Secondary outcome anxiety level of anxiety and blood pressure measurement by Dental anxiety faces version ( MCDAS-simplified) scores from 1to 5 minimal it is 1 maximal it is 20 maximam it is wors Blood pressure measurement by Automated blood pressure device unit Millimetres of mercury 3month
See also
  Status Clinical Trial Phase
Completed NCT05584696 - Effectiveness of Green Color Exposure on Dental Anxiety N/A
Not yet recruiting NCT03229720 - Evaluation of Audio-Visual Distraction Technique on Child's Anxiety N/A
Not yet recruiting NCT06116994 - The Effect of Using Camouflaged Dental Syringe N/A
Recruiting NCT05585905 - Virtual Reality in Pediatric Dentistry N/A
Terminated NCT03943836 - Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy N/A
Not yet recruiting NCT03872934 - Effect of Different Music Types on Implant Surgery Anxiety
Recruiting NCT05405088 - Identification of Predictive Factors of Postoperative Pain After Oral Surgery From Phenotypic Parameters Easily Accessible Preoperatively (PHEDOPO) N/A
Recruiting NCT04942145 - Effect of Virtual Reality on Dental Patients N/A
Not yet recruiting NCT04215055 - Comparative Evaluation Between the Effectiveness of Vibration Assisted Syringe and Conventional Syringe N/A
Recruiting NCT04609956 - Virtual Reality Technology on Pain Perception and Anxiety Levels in Adolescents and Young Adults During Third Molar Germ Avulsion Surgery (VIDAMO) N/A
Completed NCT05126459 - A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients Phase 3
Not yet recruiting NCT06133868 - The Efficacy of Lavender and Chamomile Essential Oils Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anesthesia Administration and Primary Tooth Extraction N/A
Completed NCT04762654 - Turkish Version of Modified Child Dental Anxiety Scale