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

Aromatherapy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06063512
• Other study ID #: aromatherapy in dentistry
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: shaimaa abdelazim, masters
• Phone: +2001120155777
• Email: shimaa.abdelazeem[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aromatherapy
• Respiratory Aspiration

Intervention

Other:
• sweet orange oil inhalation
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	Pulse rate	Through study completion , within 10 months
Primary	Anxiety	Modified child dental anxiety scale	Through study completion , within 10 months
Secondary	Dental pain	Wong Baker pain rating scale	Through study completion , within 10 months