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

Damascus University78 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Anxiety, Dental

Interventions

Valerian extractDIETARY_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.

Chamomile extractDIETARY_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.

Water (Placebo)OTHER

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 10 Years

Medical Language ↔ Plain English

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: * 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.

Locations (1)

Department of Pediatric Dentistry, Faculty of Dentistry, Damascus University

Damascus, Syria

Outcomes

Primary Outcomes

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.

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

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

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

Data from ClinicalTrials.gov

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