Health TrialsbyHealthPanel

Lavender vs Bitter Orange Aromatherapy to Reduce Anxiety and Pain in Pediatric Local Anesthesia

ConditionsDental AnxietyLocal Anesthesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorOctober University for Modern Sciences and Arts

About this trial

This randomized controlled clinical trial aims to evaluate and compare the effectiveness of lavender essential oil and bitter orange essential oil aromatherapy in reducing dental anxiety and pain in children during the administration of local anesthesia. Children aged 6-12 years undergoing dental procedures requiring local anesthetic infiltration will be randomly assigned to lavender aromatherapy, bitter orange aromatherapy, or placebo (empty inhaler). Dental anxiety will be assessed using pulse rate and blood pressure measurements, while pain will be evaluated using the FLACC behavioral pain scale. The findings are expected to provide evidence on the role of aromatherapy as a non-pharmacological, safe, and cost-effective behavior guidance method in pediatric dentistry.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children with the age range of 6-12 years

Any dental procedure that requires injection of local anesthesia.

Cooperative patients.(according to Frankl's classification class 1 and 2)

Parents or guardians willing to participate in the study.

Disqualifiers

Children with complicated systemic disease.

Uncooperative patients. .(according to Frankl's classification class 3 and 4)

Children with severe cognitive impairment or developmental disorders

Children with respiratory tract infections.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Lavender essential oil in the inhaler

    Behavioral

    The children will be asked to inhale the aroma (Lavender) from the inhalers for 2 minutes before local anesthetic agent injection to reduce pain and anxiety.

  • Bitter Orange essential oil in the inhaler

    Behavioral

    The children will be asked to inhale the aroma ( bitter Orange) from the inhalers for 2 minutes before local anesthetic agent injection to reduce pain and anxiety.

  • Epmty inhaler (Placebo)

    Behavioral

    The children will be asked to inhale from an empty inhaler for 2 minutes before local anesthetic agent injection.

Treatment groups

26 Participants
are divided into 3 treatment groups
Group A: Arm A: Lavender essential oil then Bitter Orange essential oil then PlaceboExperimental treatment 3 interventions
Group B: Arm B: Bitter Orange essential oil then Lavender essential oil then PlaceboExperimental treatment 3 interventions
Group C: Arm C: Placebo then Lavender essential oil then Bitter Orange essential oilActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Anxiety level (objective)

tool: pulse oximeter unit: beats per minute

Time frame
baseline (5 minutes before session), during injection (real time), and immediately post injection (within 5 minutes)

Secondary outcomes

1

anxiety level (objective)

tool: digital blood pressure monitor, unit: systolic/diastolic mmhg

Time frame
immediately before the injection (baseline), immediately after the injection (post injection)
2

pain assessment

assessment of pain by FLACC (face-leg-activity-cry-consolability) scale score (0-2) (0 is the best outcome) (2 is the worst)

Time frame
during the injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

October University for Modern Sciences and Arts

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: