The Effects of Sandalwood Aromatherapy on Anxiety Levels of Pediatric (ESAA)

June 16, 2023 updated by: Aisha Mohammed Hamzi

The Effects of Sandalwood Aromatherapy (Santalum Album) and Lavender Oil on Anxiety Levels of Pediatric Patients Undergoing Dental Extraction

Aim of the study:

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The effects of sandalwood oils on anxiety levels of pediatric
first group sandalwood aromatherapy
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
Other Names:
  • Lavender oil
Active Comparator: The effects of Lavender oils on anxiety levels of pediatric
second group lavender oil
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
Other Names:
  • Lavender oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
primary outcome it is pulse rate for child undergoing extraction
Time Frame: 3 month
It is measurement by Automated pressure device ((unit of M blood minute (1-5)
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary outcome anxiety level of anxiety and blood pressure
Time Frame: 3month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aisha Mohammed Hamzi

Collaborators

clinical professor

Investigators

  • Study Director: Kamal El-Motayam, Professor, professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

June 8, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Estimated)

June 19, 2023

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • effects sandalwood on anxiety

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety, Dental

Clinical Trials on sandalwood aromatherapy (Santalum album)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe