Compare the Intensity of Pain Felt by Children During the Local Anesthesia Procedure to That Perceived by the Accompanying Parent. (ADDenT)

The goal of this observational study is to compare the intensity of pain experienced by children (aged 6 to 15) during local anaesthesia with that perceived by the parent accompanying them. The main question it aims to answer is:

Can a parent help assess their child's pain when the child is unable to assess it themselves? A preliminary study carried out in the dentistry department of Clermont-Ferrand University Hospital in 2019 showed that parents could be effective external assessors in distinguishing between pain and anxiety in their own children, whom they know well, and were better at this than dentists, who are more prone to errors of judgement.13 This pilot study covered several dental procedures, including pulpotomy, extraction of a primary tooth, curettage of a carious lesion and dental anaesthesia. The study yielded interesting results but also contained some biases, so the investigators would like to improve upon it. To do so, the focus here is on a single therapeutic procedure: local anaesthesia, which is one of the procedures most feared by children and, very often, by the parents accompanying them as well.

Once consent has been obtained from both parents (or legal guardians), two questionnaires will be used. The first will consist of simple questions and will be aimed at the children (9 items). The second (20 items) will be for parents and will provide additional information on the child's state of health and on the parents' anxiety regarding their own dental care and that provided to their child. The main aim of both questionnaires will be to assess the intensity of pain perceived by the child during the administration of local anaesthesia, with the child self-reporting their pain and the parent providing an external assessment. These questionnaires will be completed every Wednesday, which allows a child (requiring multiple treatments) to complete the questionnaires several times, thereby enabling us to observe changes in the pain perceived by the child and their accompanying parent over the course of successive anaesthetic procedures.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Anxiety; Dental Pain

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 0473754963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand
    • Principal Investigator: Anne MISHELLANY-DUTOUR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Dental Department, Estaing University Hospital, Clermont-Ferrand

Description

Inclusion Criteria:

• Children aged 6 to 15
• Children requiring dental treatment involving local anaesthetic
• Children accompanied by at least one parent (or legal guardian)
• Children and parents who speak French fluently

Exclusion Criteria:

• Children under the age of 6 (complex self-assessment)
• Children over the age of 15 (no longer fall within the scope of paediatric dentistry)
• Children or accompanying parents who have difficulty understanding due to a limited command of French or any form of intellectual disability
• Children whose parents have not consented to their participation in the study
• Children who do not wish to participate in the study
• Unaccompanied children
• Children with an intolerance or allergy to local anaesthetics, vasoconstrictors or excipients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of pain (Numerical Rating Scale: NRS) as reported by the child and as perceived by the parent	Pain intensity assessed using a 0-10 Numerical Rating Scale (NRS), as self-reported by the child and independently rated by the parent according to their perception of the child's pain.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of anxiety in children and parents regarding dental anaesthesia (Numerical Rating Scale: NRS)	Anxiety related to dental anaesthesia assessed using a 0-10 Numerical Rating Scale (NRS), as self-reported by the child and independently self-reported by the parent.	Day 1
To investigate the correlation between 2 measurements: anxiety (Numerical Rating Scale: NRS) about dental treatment and the assessment of pain intensity (Numerical Rating Scale: NRS)	Association between anxiety related to dental treatment and pain intensity, both assessed using a 0-10 Numerical Rating Scale (NRS). Correlation analysis will be performed to evaluate the relationship between these two measures reported by the children and their accompanying parents (or legal guardians), depending on normality of data, correlation will be assessed using Pearson or Spearman coefficient	Day 1
Create a categorical score for children with multiple medical conditions and pain during anaesthesia	The medical score will equal the weighted sum of medical conditions (0 = absence, 1 moderate, 2 severe for each condition), and that score will be correlated with pain score using either Pearson or Spearman coefficient depending on normality of data	Day 1
To investigate the correlation between 2 measurements: pre-operative pain history (Numerical Rating Scale: NRS) and the assessment of pain intensity (Numerical Rating Scale: NRS)	The association between pre-operative pain history and pain intensity during dental anaesthesia will be evaluated. Pre-operative pain history and pain intensity will both be assessed using a 0-10 Numerical Rating Scale (NRS). Correlation analysis will be performed to evaluate the relationship between these two measures, depending on normality of data, correlation will be assessed using Pearson or Spearman coefficient	Day 1
Monitor changes in pain intensity from the first anaesthetic administration to the last, should the patient return for treatment (Numerical Rating Scale: NRS)	Changes in pain intensity will be assessed using a 0-10 Numerical Rating Scale (NRS) by comparing pain scores reported during the first dental anaesthesia session with those reported during the last anaesthesia session in children who return for subsequent treatment, by using either a pearson/spearman correlation or an Intra Class correlation, similarly to a test-retest assessement.	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; University Clermont Auvergne (UCA), Clermont-Ferrand, France; Laboratory NeuroDol U1107 Inserm

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: children; anxiety; parents; pediatric odontology; dental pain assessment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Mental Disorders; Tooth Diseases; Facial Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anxiety Disorders; Toothache
• Other Study ID Numbers: RNI 2025 DUTOUR

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