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

Primary Purpose

Anxiety, Dental

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sandalwood aromatherapy (Santalum album)
Sponsored by
Aisha Mohammed Hamzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety, Dental

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Egyptian children from 6 to 12 years old undergo primary tooth extraction. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    The effects of sandalwood oils on anxiety levels of pediatric

    The effects of Lavender oils on anxiety levels of pediatric

    Arm Description

    first group sandalwood aromatherapy

    second group lavender oil

    Outcomes

    Primary Outcome Measures

    primary outcome it is pulse rate for child undergoing extraction
    It is measurement by Automated pressure device ((unit of M blood minute (1-5)

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    June 8, 2023
    Last Updated
    June 16, 2023
    Sponsor
    Aisha Mohammed Hamzi
    Collaborators
    clinical professor
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05908981
    Brief Title
    The Effects of Sandalwood Aromatherapy on Anxiety Levels of Pediatric
    Acronym
    ESAA
    Official Title
    The Effects of Sandalwood Aromatherapy (Santalum Album) and Lavender Oil on Anxiety Levels of Pediatric Patients Undergoing Dental Extraction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2024 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Aisha Mohammed Hamzi
    Collaborators
    clinical professor

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Dental

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    The effects of sandalwood oils on anxiety levels of pediatric
    Arm Type
    Active Comparator
    Arm Description
    first group sandalwood aromatherapy
    Arm Title
    The effects of Lavender oils on anxiety levels of pediatric
    Arm Type
    Active Comparator
    Arm Description
    second group lavender oil
    Intervention Type
    Other
    Intervention Name(s)
    sandalwood aromatherapy (Santalum album)
    Other Intervention Name(s)
    Lavender oil
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    primary outcome it is pulse rate for child undergoing extraction
    Description
    It is measurement by Automated pressure device ((unit of M blood minute (1-5)
    Time Frame
    3 month
    Secondary Outcome Measure Information:
    Title
    Secondary outcome anxiety level of anxiety and blood pressure
    Description
    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
    Time Frame
    3month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Egyptian children from 6 to 12 years old undergo primary tooth extraction. 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aisha hamzi, mastar
    Phone
    96651430651
    Email
    aisha.hamzi@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reem wahby, phd
    Email
    reem.wahby@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kamal El-Motayam, Professor
    Organizational Affiliation
    Professor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    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.
    Results Reference
    result
    PubMed Identifier
    28070420
    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.
    Results Reference
    result

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    The Effects of Sandalwood Aromatherapy on Anxiety Levels of Pediatric

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