Chamomile versus valerian to reduce anxiety in children having a tooth removed
The Effect of Valerian and Chamomile on Pediatric Dental Anxiety: A Randomized Controlled Trial
This trial will test if a dose of chamomile or valerian given before a simple tooth extraction can help lower anxiety in healthy children aged 6 to 10.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 6 Years to 10 Years |
| Sex | All |
| Sponsor | Damascus University Academic / other |
| Locations | 1 site (Damascus) |
| Trial ID | NCT07515612 on ClinicalTrials.gov |
What this trial studies
This randomized, placebo-controlled trial assigns healthy children aged 6–10 who need a simple upper primary molar extraction to receive chamomile extract, valerian extract, or a placebo prior to the procedure. Anxiety is measured with a child-friendly self-report scale, an observer-rated behavior scale, and physiological measures (heart rate and blood pressure). Eligible children must have positive behavior on the Frankl scale and no systemic or mental disease, and exclusions include known herb hypersensitivity or recent sedative/analgesic use. The trial compares short-term anxiolytic effects and safety of the two herbal extracts versus placebo in a routine pediatric dental setting.
Who should consider this trial
Good fit: Healthy children aged 6–10 with positive behavior (Frankl rating) who require a simple upper primary molar extraction under local anesthesia are the intended participants.
Not a fit: Children with allergies to chamomile or valerian, recent use of sedatives/analgesics, systemic or mental health conditions, or unwillingness to ingest the intervention are unlikely to qualify or benefit.
Why it matters
Potential benefit: If effective, these herbal extracts could provide a safe, easy-to-administer option to reduce anxiety and improve cooperation during children’s dental extractions.
How similar studies have performed: Chamomile and valerian have shown anxiolytic effects in other medical contexts, but direct evidence for reducing pediatric dental anxiety is limited and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Healthy children with no systemic or mental diseases. 2. Children aged 6-10 years. 4. Children with positive behavior according to the Frankl behavior rating scale. 5\. Children requiring a simple tooth extraction of upper primary molars under local anesthesia. Exclusion Criteria: 1. Children whose parents refused participation in the study. 2. Children who were unwilling to ingest any of the herbal extracts. 3. Children with a history of hypersensitivity to chamomile or valerian. 4. Children who had taken any sedative, anxiolytic or analgesic medications within the last 8 hours prior to treatment.
Where this trial is running
Damascus
- Department of Pediatric Dentistry, Faculty of Dentistry, Damascus University — Damascus, Syria (Recruiting)
Study contacts
- Principal investigator: Juman Hayo, DDS — Faculty of Dentistry, University of Damascus
- Study coordinator: Juman Hayo, MSc Student
- Email: Juman.MH29@gmail.com
- Phone: 00963936487388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.