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

Study Overview
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Brief Summary
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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
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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)

Official Title
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The Efficacy of Sweet Orange Oil Inhalation in Management of Dental Anxiety and Pain in Children Undergoing Local Anaesthetic Administration: A Randomized Clinical Trial

Conditions
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Aromatherapy

Intervention / Treatment
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* Other: sweet orange oil inhalation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (sweet orange oil group)<br>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. | Other: sweet orange oil inhalation<br>* 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<br>|
| No Intervention: For Group B (Control Group)<br>No aromatherapy inhalation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Pulse rate | Through study completion , within 10 months | 
| Anxiety | Modified child dental anxiety scale | Through study completion , within 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental pain | Wong Baker pain rating scale | Through study completion , within 10 months |