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

NCT06063512 | Unknown

• 1 other identifier: aromatherapy in dentistry
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aromatherapy

Outcome Measures

Primary Outcomes (2)

• Anxiety

  Pulse rate

  Through study completion , within 10 months

• Anxiety

  Modified child dental anxiety scale

  Through study completion , within 10 months

Secondary Outcomes (1)

• Dental pain

  Through study completion , within 10 months

Study Arms (2)

Group A (sweet orange oil group)

EXPERIMENTAL

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

For Group B (Control Group)

NO INTERVENTION

No aromatherapy inhalation

Interventions

sweet orange oil inhalation OTHER

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

Group A (sweet orange oil group)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• 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.

  PMID: 34849354 BACKGROUND

Central Study Contacts

shaimaa abdelazim, masters

CONTACT

+2001120155777; shimaa.abdelazeem@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Princupal investigator /shaimaa Abdelazim

Model Details: 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.

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: October 2, 2023
• Study Start: September 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-09