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

17. juli 2026 opdateret af: University Hospital, Clermont-Ferrand

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Clermont-Ferrand, Frankrig
        • CHU Clermont-Ferrand
        • Ledende efterforsker:
          • Anne MISHELLANY-DUTOUR

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Dental Department, Estaing University Hospital, Clermont-Ferrand

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of pain (Numerical Rating Scale: NRS) as reported by the child and as perceived by the parent
Tidsramme: Day 1
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assessment of anxiety in children and parents regarding dental anaesthesia (Numerical Rating Scale: NRS)
Tidsramme: Day 1
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)
Tidsramme: Day 1
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
Tidsramme: Day 1
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)
Tidsramme: Day 1
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)
Tidsramme: Day 1
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Clermont-Ferrand

Samarbejdspartnere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2028

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

17. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RNI 2025 DUTOUR

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