Clinical trial NCT06063512: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aromatherapy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 64
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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)

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.

Primary outcomes:
measure: Anxiety
timeFrame: Through study completion , within 10 months
measure: Anxiety
timeFrame: Through study completion , within 10 months
Secondary outcomes:
measure: Dental pain
timeFrame: Through study completion , within 10 months
Other outcomes:
Locations:
Study officials:
References:
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.