Assessing the Efficacy of Lemongrass and Lavender Aromatherapy in Reducing Dental Anxiety and Pain Associated With Local Anesthetic Injections in Pediatric Dental Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age7-11
SponsorHiba Ahmed Eltayeb

About this trial

The goal of this clinical trial is to evaluate whether aromatherapy using lemongrass or lavender essential oils can reduce dental anxiety and pain perception in children aged 7-11 years undergoing local anesthetic administration in a pediatric dental setting.

The main questions it aims to answer are:

Does lemongrass or lavender aromatherapy reduce anxiety levels, as measured by salivary cortisol, in children receiving local anesthesia?

Does aromatherapy influence pain perception and physiological stress (heart rate) during the procedure?

Researchers will compare a lavender aromatherapy group, a lemongrass aromatherapy group, and a control group without aromatherapy to see if the essential oils have a calming effect that reduces anxiety and pain compared to no intervention.

Participants will:

Inhale either lavender, lemongrass, or no essential oil (control) for two minutes via nebulizer.

Undergo local anesthesia administration for a dental procedure.

Provide unstimulated and stimulated saliva samples before and after the procedure for cortisol analysis.

Report their pain level using the Wong-Baker Faces Pain Rating Scale.

Have their heart rate measured before and after the procedure using a finger-type pulse oximeter.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

children aged 7-11 years

medically free

children category 3 or 4 according to Frankle behavior rating scale

patients who approve of signing informed consent and give child assent

Disqualifiers

children with a previous dental visit

children suffering from any upper or lower respiratory tract problems

children with any history of allergy children who currently use any medications

Trial design

Design model

Parallel

Treatments tested in this trial

  • lavender essential oil inhaled using face mask

    Drug

    participants will inhale lavender essential oil via nebulizer before local anesthesia administration

  • lemongrass essential oil inhaled using face mask

    Drug

    participants will inhale lemongrass essential oil via nebulizer before the local anesthesia administration

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: lavender aromatherapyActive comparator 1 intervention
Group B: lemongrass aromatherapyActive comparator 1 intervention
Group C: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

anxiety level

anxiety will be measured by measuring salivary cortisol levels after taking saliva samples

Time frame
salivary cortisol will be assessed by taking saliva samples at baseline, and within 30 minutes of the procedure

Secondary outcomes

1

pain perception

using Wong-Baker faces pain rating scale Arabic version, the scale has six faces from a happy face for no pain to a crying face for extreme pain, scoring from 0 to 10. Children will be asked to choose the face that expresses their perceived pain intensity

Time frame
immediately after local anesthetic administration
2

physiological changes(heart rate)

using a finger-type pulse oximeter

Time frame
as baseline and 1 minute after local anesthetic administration

Other outcomes

Sponsors and contacts

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

Hiba Ahmed Eltayeb

Lead sponsor

Ain Shams University

Sponsor institution