An observational study in Dental Pain and Dental Anxiety, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by University Hospital, Clermont-Ferrand · Observational
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.
Dental Department, Estaing University Hospital, Clermont-Ferrand
Exclusion Criteria:
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.
Time frame: Day 1
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Day 1
Plan to share: No
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University Hospital, Clermont-Ferrand