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

March 31, 2026 updated by: Damascus University

The Effect of Valerian and Chamomile on Pediatric Dental Anxiety: A Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Syria
      • Damascus, Syria
        • Recruiting
        • Department of Pediatric Dentistry, Faculty of Dentistry, Damascus University
        • Contact:
        • Principal Investigator:
          • Juman Hayo, MSc Student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Water
Other: Water (Placebo)
Participants will receive a small amount of water 30 minutes prior to local anesthesia and tooth extraction.
Experimental: Valerian extract
Dietary supplement: Valerian 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.
Experimental: Chamomile extract
Dietary supplement: Chamomile 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported dental anxiety level
Time Frame: Before the herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia - immediately after extraction.
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
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological response to dental anxiety - Heart rate
Time Frame: Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia
Heart rate will be measured using an electronic digital blood pressure monitor with a sleeve designed for children
Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia
Physiological response to dental anxiety - Blood pressure
Time Frame: Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia
Systolic and diastolic blood pressure will be measured using an electronic digital blood pressure monitor with a sleeve designed for children
Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Principal Investigator: Juman Hayo, DDS, Faculty of Dentistry, University of Damascus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

April 15, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-7-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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