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

NCT07515612 | Active Not Recruiting DMC

• 1 other identifier: UDDS-Pedo-7-2025
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety, Dental

Keywords

dental anxiety; pediatric dentistry; herbal medicine; phytotherapy; chamomile; valerian; behavior management

Outcome Measures

Primary Outcomes (2)

• 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).

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

• 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.

  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 (2)

• Physiological response to dental anxiety - Heart rate

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

• Physiological response to dental anxiety - Blood pressure

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

Study Arms (3)

Valerian extract

EXPERIMENTAL

Dietary Supplement: Valerian extract

Chamomile extract

EXPERIMENTAL

Dietary Supplement: Chamomile extract

Water

PLACEBO COMPARATOR

Other: Water (Placebo)

Interventions

Valerian extract DIETARY_SUPPLEMENT

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.

Valerian extract

Chamomile extract DIETARY_SUPPLEMENT

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.

Chamomile extract

Water (Placebo) OTHER

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

Water

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Pediatric Dentistry, Faculty of Dentistry, Damascus University

Damascus, Syria

Location

Related Publications (7)

• 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.

  PMID: 38784853 BACKGROUND

• 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.

  PMID: 32795578 BACKGROUND

• 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.

  PMID: 24741279 BACKGROUND

• 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.

  PMID: 39514279 BACKGROUND

• 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.

  PMID: 24837472 BACKGROUND

• 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.

  PMID: 38743126 BACKGROUND

• 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.

  PMID: 31158346 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Valeriana extract; Chamomile extract; Water

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Juman Hayo, DDS

  Faculty of Dentistry, University of Damascus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: December 1, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)