Anxiety, DentalNCT07515612
The Impact of Valerian and Chamomile on Children's Anxiety in the Dental Clinic
A study testing Valerian extract and Chamomile extract in people with Anxiety, Dental, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Anxiety, Dental
- What is being tested?
- Valerian extract and Chamomile extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSyria
- Study dates
- 1 Dec 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Pediatric Dentistry, Faculty of Dentistry, Damascus University
Damascus
About this study
Official title: 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.
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.
- Conditions
- Anxiety, Dental
- Being tested
- Valerian extract, Chamomile extract, Water (Placebo)
- Keywords
- dental anxiety, pediatric dentistry, herbal medicine, phytotherapy, chamomile, valerian, behavior management
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Valerian extract | Experimental | Not described Receives: Dietary Supplement: Valerian extract |
| Chamomile extract | Experimental | Not described Receives: Dietary Supplement: Chamomile extract |
| Water | Placebo comparator | Not described Receives: Other: Water (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Heart rate will be measured using an electronic digital blood pressure monitor with a sleeve designed for children
Measured: 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
Measured: Before herbal extract administration - after 30 minutes from ingestion - after 5 minutes from local anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Dec 2025
- Primary completion15 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Anxiety, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juman Hayo, DDS, Principal investigator, Faculty of Dentistry, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515612
- Sponsor's protocol ID
- UDDS-Pedo-7-2025
- Status last verified
- Aug 2026
- First submitted
- 31 Mar 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 38784853Chaves 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 32795578Pinheiro 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 24741279Zampieri 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 39514279Gromball 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 24837472Velasquez 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 38743126Farah 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Valerian and Chamomile on Pediatric Dental Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07515612
- Acronym / sponsor ID
- UDDS-Pedo-7-2025
- Conditions
- Anxiety, Dental
- Keywords
- dental anxiety, pediatric dentistry, herbal medicine, phytotherapy, chamomile, valerian, behavior management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Valerian extract | Experimental | Dietary Supplement: Valerian extract |
| Chamomile extract | Experimental | Dietary Supplement: Chamomile extract |
| Water | Placebo comparator | Other: Water (Placebo) |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valerian extractParticipants 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 supplement | Valerian extract |
| Chamomile extractParticipants 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. | Dietary supplement | Chamomile extract |
| Water (Placebo)Participants will receive a small amount of water 30 minutes prior to local anesthesia and tooth extraction. | Other | Water |
Primary outcome
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).
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.
2 secondary outcomes
Physiological response to dental anxiety - Heart rate
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Background: PubMed 38784853Saadatmand 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.
- Background: PubMed 32795578Chaves 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.
- Background: PubMed 24741279Pinheiro 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.
- Background: PubMed 39514279Zampieri 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.
- Background: PubMed 24837472Gromball 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.
- Background: PubMed 38743126Velasquez 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.
- Background: PubMed 31158346Farah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juman Hayo, DDS principal investigator
Faculty of Dentistry, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valerian extract and Chamomile extract in people with Anxiety, Dental, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07515612, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.