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The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain

Primary Purpose

Aromatherapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sweet orange oil inhalation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Aromatherapy

Eligibility Criteria

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

Inclusion Criteria: • Children classified with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale. Children aged 8-12 years. Patients who need maxillary infiltration anaesthesia in the first dental visit. Exclusion Criteria: Children with any neurological or psychological disorders. Children with previous LA administration. Presence of dental or medical emergency. Presence of systemic disorders. Chidren with common cold. Children with known allergy to topical or local anesthetic agents. Parental refusal for participation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Group A (sweet orange oil group)

    For Group B (Control Group)

    Arm Description

    Aromatherapy with inhalers will be carried out in an open clinical setting. Three drops of sweet orange oil will be dispensed into a cotton wick of the inhaler, The children will be asked to inhale the aroma from the inhalers for 2 minutes followed by an induction period of 15 minutes.

    No aromatherapy inhalation

    Outcomes

    Primary Outcome Measures

    Anxiety
    Pulse rate
    Anxiety
    Modified child dental anxiety scale

    Secondary Outcome Measures

    Dental pain
    Wong Baker pain rating scale

    Full Information

    First Posted
    September 11, 2023
    Last Updated
    September 28, 2023
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06063512
    Brief Title
    The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain
    Official Title
    The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anaesthetic Administration: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    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 To evaluate the effectiveness of sweet orange oil inhalation in reducing dental anxiety and pain in children undergoing local anaesthetic administration.
    Detailed Description
    Research Question: Can sweet orange oil help to overcome dental anxiety and pain in children undergoing local anaesthetic administration? PICO approach: P: Children 8 to 12 years old need dental treatment under local anesthesia. I: Sweet Orange oil inhalation. C: Without aromatherapy. O: Primary Outcome Dental Anxiety Modified Child Dental Anxiety Scale - Faces version [MCDAS(f)-simplified] Pulse rate Secondary Outcome Pain Wong-Baker pain rating scale (WBS)

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The two parallel groups will receive the maxillary anaesthesia injection by the same operator. In the pre-operative period, MCDAS(f), a self-report measure of anxiety will be recorded for all the children. Measuring preoperative dental anxiety (expressed by heart rate) using pulse oximeter For Group A (sweet orange oil group): Aromatherapy with inhalers will be carried out, The children will be asked to inhale the aroma from the inhaler For Group B (Control Group): No aromatherapy inhalation . Administration of topical anesthesia . Administration of local anesthesia . After LA administration, Wong-Baker pain rating scale (WBS) will be recorded as a self report measure of pain for all the children. After LA administration, anxiety will be recorded again using MCDAS(f) for all the children. Measuring postoperative dental anxiety (expressed by heart rate ) using pulse oximeter.
    Masking
    ParticipantInvestigator
    Masking Description
    Blinding of the operator and the patients will not be feasible due to the difference between the used techniques. However, the statistician will be blinded.
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (sweet orange oil group)
    Arm Type
    Experimental
    Arm Description
    Aromatherapy with inhalers will be carried out in an open clinical setting. Three drops of sweet orange oil will be dispensed into a cotton wick of the inhaler, The children will be asked to inhale the aroma from the inhalers for 2 minutes followed by an induction period of 15 minutes.
    Arm Title
    For Group B (Control Group)
    Arm Type
    No Intervention
    Arm Description
    No aromatherapy inhalation
    Intervention Type
    Other
    Intervention Name(s)
    sweet orange oil inhalation
    Intervention Description
    sweet orange oil with inhalers will be carried out in an open clinical setting. Three drops of sweet orange oil will be dispensed into a cotton wick of the inhaler, The children will be asked to inhale the aroma from the inhalers for 2 minutes followed by an induction period of 15 minutes
    Primary Outcome Measure Information:
    Title
    Anxiety
    Description
    Pulse rate
    Time Frame
    Through study completion , within 10 months
    Title
    Anxiety
    Description
    Modified child dental anxiety scale
    Time Frame
    Through study completion , within 10 months
    Secondary Outcome Measure Information:
    Title
    Dental pain
    Description
    Wong Baker pain rating scale
    Time Frame
    Through study completion , within 10 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Children classified with rating 3 (positive) or 4 (definitely positive) according to Frankl behaviour rating scale. Children aged 8-12 years. Patients who need maxillary infiltration anaesthesia in the first dental visit. Exclusion Criteria: Children with any neurological or psychological disorders. Children with previous LA administration. Presence of dental or medical emergency. Presence of systemic disorders. Chidren with common cold. Children with known allergy to topical or local anesthetic agents. Parental refusal for participation.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    shaimaa abdelazim, masters
    Phone
    +2001120155777
    Email
    shimaa.abdelazeem@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34849354
    Citation
    Nirmala K, Kamatham R. Effect of Aromatherapy on Dental Anxiety and Pain in Children Undergoing Local Anesthetic Administrations: A Randomized Clinical Trial. J Caring Sci. 2021 Aug 23;10(3):111-120. doi: 10.34172/jcs.2021.026. eCollection 2021 Aug.
    Results Reference
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    The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain

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