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

NCT07718477 | Not Yet Recruiting

• 1 other identifier: RNI 2025 DUTOUR
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Pain; Dental Anxiety

Keywords

pediatric odontology; dental pain assessment; anxiety; children; parents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of anxiety in children and parents regarding dental anaesthesia (Numerical Rating Scale: NRS)

  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)

  Day 1

• Create a categorical score for children with multiple medical conditions and pain during anaesthesia

  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)

  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)

  Day 1

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Dental Department, Estaing University Hospital, Clermont-Ferrand

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Toothache; Anxiety Disorders

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)