ClinicalTrials.gg
CompletedNCT07515612Updated Sep 1, 2026

The Impact of Valerian and Chamomile on Children's Anxiety in the Dental Clinic

An interventional study of Valerian extract and Chamomile extract in Anxiety, Dental, sponsored by Damascus University. Completed at 1 site in Syria. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Dec 2025, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study summary

This randomized controlled clinical trial aims to evaluate and compare the effectiveness of chamomile extract and valerian extract in reducing dental anxiety in healthy pediatric patients aged 6 to 10 years undergoing tooth extraction. Participants will be randomly assigned to receive one of the herbal interventions or a placebo prior to extraction. Dental anxiety will be assessed using validated anxiety rating scales and physiological parameters. This study seeks to explore a safe, easy to apply, and effective approach to manage child behavior and reduce dental anxiety.

Read the detailed description

Dental anxiety in children is a common issue that can negatively affect oral health, behavior, and overall well-being. While various pharmacological and non-pharmacological strategies exist to manage pediatric dental anxiety, there is still a need for approaches that are safe, accessible, and practical for routine clinical use. Herbal interventions, such as chamomile and valerian, have demonstrated anxiolytic and sedative effects in other medical settings, but their comparative effectiveness in reducing dental anxiety in children has not been fully studied.

This randomized controlled trial investigates the potential of these herbal extracts to reduce anxiety in children aged 6-10 years undergoing simple tooth extraction. Participants will be randomly assigned to one of three groups, receiving either chamomile, valerian, or a placebo prior to treatment. Anxiety will be assessed using multiple complementary methods: a child-friendly self-report scale, an observer-rated behavior scale, and physiological measures including blood pressure and heart rate.

By combining these assessment tools, the study provides a comprehensive evaluation of both psychological and physiological aspects of dental anxiety. The findings will offer insights into whether these herbal extracts can reduce dental anxiety safely and effectively, guiding pediatric dentists in implementing natural interventions to improve children's dental experiences.

02

Conditions studied

  • Anxiety, Dental

Browse trials for

Keywords

  • dental anxiety
  • pediatric dentistry
  • herbal medicine
  • phytotherapy
  • chamomile
  • valerian
  • behavior management
03

In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 78 is close to the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy children with no systemic or mental diseases.
  • Children aged 6-10 years.
  • Children with positive behavior according to the Frankl behavior rating scale.
  • Children requiring a simple tooth extraction of upper primary molars under local anesthesia.

Exclusion criteria

Exclusion Criteria:

  • Children whose parents refused participation in the study.
  • Children who were unwilling to ingest any of the herbal extracts.
  • Children with a history of to chamomile or valerian.
  • Children who had taken any sedative, anxiolytic or analgesic medications within the last 8 hours prior to treatment.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Valerian extract

    Dietary Supplement: Valerian extract

  • Experimental
    Chamomile extract

    Dietary Supplement: Chamomile extract

  • Placebo comparator
    Water

    Other: Water (Placebo)

Interventions

  • Dietary supplementValerian extract

    Participants will receive 1 mL of valerian root liquid extract (Valeriana officinalis L., 1000 mg/mL), diluted in a small amount of apple juice, 30 minutes prior to local anesthesia and tooth extraction.

  • Dietary supplementChamomile extract

    Participants will receive 2 ml of German chamomile flower liquid extract (Matricaria recutita, 2400 mg/2 mL), diluted in a small amount of water, 30 minutes prior to local anesthesia and tooth extraction.

  • OtherWater (Placebo)

    Participants will receive a small amount of water 30 minutes prior to local anesthesia and tooth extraction.

06

What researchers measure

Primary outcomes

  1. Self-reported dental anxiety level

    Dental anxiety will be assessed using the Animated Emoji Scale (AES); a scale that consists of five facial expressions (emojis) scored from 1 (no anxiety) to 5 (high anxiety).

    Time frame: Before the herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia - immediately after extraction.

  2. Non-self-reported dental anxiety level

    Dental anxiety will be assessed using the Houpt Behavior Rating Scale, by an independent external observer based on video recordings.

    Time frame: Throughout the dental procedure: 1. during local anesthesia (from needle insertion until needle withdrawal) 2. during extraction (from the initial application of forceps until complete tooth removal)

Secondary outcomes

  1. Physiological response to dental anxiety - Heart rate

    Heart rate will be measured using an electronic digital blood pressure monitor with a sleeve designed for children

    Time frame: Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia

  2. Physiological response to dental anxiety - Blood pressure

    Systolic and diastolic blood pressure will be measured using an electronic digital blood pressure monitor with a sleeve designed for children

    Time frame: Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia

07

Study locations

1 site
  • Department of Pediatric Dentistry, Faculty of Dentistry, Damascus University
    Damascus, Syria
08

References and documents

Publications

  • Saadatmand S, Zohroudi F, Tangestani H. The Effect of Oral Chamomile on Anxiety: A Systematic Review of Clinical Trials. Clin Nutr Res. 2024 Apr 23;13(2):139-147. doi: 10.7762/cnr.2024.13.2.139. eCollection 2024 Apr. PubMed 38784853 ↗
  • Chaves PFP, Hocayen PAS, Dallazen JL, de Paula Werner MF, Iacomini M, Andreatini R, Cordeiro LMC. Chamomile tea: Source of a glucuronoxylan with antinociceptive, sedative and anxiolytic-like effects. Int J Biol Macromol. 2020 Dec 1;164:1675-1682. doi: 10.1016/j.ijbiomac.2020.08.039. Epub 2020 Aug 11. PubMed 32795578 ↗
  • Pinheiro ML, Alcantara CE, de Moraes M, de Andrade ED. Valeriana officinalis L. for conscious sedation of patients submitted to impacted lower third molar surgery: A randomized, double-blind, placebo-controlled split-mouth study. J Pharm Bioallied Sci. 2014 Apr;6(2):109-14. doi: 10.4103/0975-7406.129176. PubMed 24741279 ↗
  • Zampieri VC, Goncalves IL, Lira AL, Zeni J, Backes GT, Hsu AKW. Exploring the Effects of a Calming Herbal Tea Blend on Perioperative Anxiety: A Randomized Clinical Trial. J Med Food. 2025 Mar;28(3):266-271. doi: 10.1089/jmf.2024.0170. Epub 2024 Nov 8. PubMed 39514279 ↗
  • Gromball J, Beschorner F, Wantzen C, Paulsen U, Burkart M. Hyperactivity, concentration difficulties and impulsiveness improve during seven weeks' treatment with valerian root and lemon balm extracts in primary school children. Phytomedicine. 2014 Jul-Aug;21(8-9):1098-103. doi: 10.1016/j.phymed.2014.04.004. Epub 2014 May 15. PubMed 24837472 ↗
  • Velasquez ACA, Tsuji M, Dos Santos Cordeiro L, Petinati MFP, Rebellato NLB, Sebastiani AM, da Costa DJ, Scariot R. Effects of Passiflora incarnata and Valeriana officinalis in the control of anxiety due to tooth extraction: a randomized controlled clinical trial. Oral Maxillofac Surg. 2024 Sep;28(3):1313-1320. doi: 10.1007/s10006-024-01259-6. Epub 2024 May 14. PubMed 38743126 ↗
  • Farah GJ, Ferreira GZ, Danieletto-Zanna CF, Luppi CR, Jacomacci WP. Assessment of Valeriana officinalis l. (Valerian) for Conscious Sedation of Patients During the Extraction of Impacted Mandibular Third Molars: A Randomized, Split-Mouth, Double-Blind, Crossover Study. J Oral Maxillofac Surg. 2019 Sep;77(9):1796.e1-1796.e8. doi: 10.1016/j.joms.2019.05.003. Epub 2019 May 9. PubMed 31158346 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07515612
Responsible party
Sponsor
First posted
Apr 7, 2026
Start date
Dec 1, 2025
Primary completion
Apr 15, 2026
Completion
Jun 30, 2026
Last update
Sep 1, 2026

Study contacts

Juman Hayo, DDS
principal investigator · Faculty of Dentistry, University of Damascus

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Valeriana extract · Chamomile extract

Start the discussion