Effect of Cartoon-assisted Visual/Auditory Distraction Method in Paediatric Dental Patients
Condition: Behavior, Child
Study type: Interventional

Summary: 
      The hypothesis of this study was to reveal the positive effects of the visual/auditory
      distraction usage on anxiety, pain and behavioural control in paediatric patients. Therefore,
      the aim of this study was to assess the effect of the cartoon-assisted audio/visual
      distraction technique usage on paediatric patient's anxiety, pain and behaviour during dental
      care.

      Children aged 4-9 years old who met inclusion criteria received restorative treatment in two
      sessions, with or without cartoon-assisted visual/auditory distraction technique. The parents
      were informed about the study following the initial dental examination of the patient and the
      written informed consents were obtained from parents of all participants included in the
      study. Following the initial dental examination, dental prophylaxis was performed to
      children. A behavioural assessment was done following a dental prophylaxis. Children who
      demonstrated a negative or positive attitude according to the behaviour assessment were
      selected. Although, children with definitely negative or definitely positive behavioural
      attitude were not selected. Subsequently, the patients were randomly assigned to two groups.

      Group 1: Dental treatment was carried out with showing cartoon movie as a visual/auditory
      distraction during the treatment in the second visit (V2). The third visit (V3) did not
      consist any visual/auditory distractions.

      Group 2: Dental treatment was carried out without any visual/auditory distraction in the V2.
      The V3 consisted cartoon movie as a visual/auditory distraction.

      Paediatric patients were able to choose any of the 12 cartoon movies that have been approved
      by two paediatric dentists who carried out the study. Before each treatment session, parents
      were kindly requested to leave the operating room. Same treatment procedures were carried out
      in both groups during each visit in the following consecutive order. During each treatment
      session, corresponding measures were observed. Corresponding measures: (1) the child's
      anxiety; (2) the child's pain perception during local anaesthesia and treatment; (3) the
      child's cooperation and general behaviour.

      The outcomes of the child's anxiety, pain perception and, cooperation and general behaviour
      for both two groups were evaluated by statistical analysis.
    

Detailed description: 
      The study was carried out in Istanbul Medipol University Department of Pedodontics, period
      between June 2022 - October 2022 following the ethics committee approval (REF:
      E-10840098-604.01.01-E.60990). The parents were informed about the study following the
      initial dental examination of the patient and the written informed consents were obtained
      from parents of all participants included in the study.

      In this randomised crossover clinical study, the sample consisted of 72 children aged between
      4-9 years old who applied for routine dental care in paediatric clinic.

      Randomization

      Following the initial dental examination eligible patients were selected (n=95) after 3
      months of recruitment (June 2022 and August 2022). Each eligible patient was evaluated for
      the inclusion and exclusion criteria. Of these patients, 7 children demonstrated definitely
      negative behaviour at the first visit (V1) and 16 children did not show-up to their scheduled
      V1, thus 23 patients were excluded. A total of 72 patients were included the study. A
      randomization list was generated using online software
      (http://www.graphpad.com/quickcalcs/index.cfm), where consecutive patients enrolled on the
      study were randomized into 2 groups with an allocation ratio of 1:1. The random allocation
      sequence was generated by an independent researcher; thus, the operator and observer were
      blinded to the assignment of the study participants to the groups as follows:

      Group 1: Dental treatment was carried out with showing cartoon movie as a visual/auditory
      distraction (group A) during the treatment in the second visit (V2). The third visit (V3) did
      not consist any visual/auditory distractions, tell-show-do (group B) technique was used as a
      behavioural guidance technique.

      Group 2: Dental treatment was carried out using tell-show-do (group B) technique without any
      visual/auditory distraction in the V2. The V3 consisted cartoon movie as a visual/auditory
      distraction (group A).

      Study Design This randomised crossover clinical study lasted five months with three months
      for recruitment and two months to allocate treatment arms, including a two-week washout
      period in between interventions. At the V1 following the initial dental examination, dental
      prophylaxis was performed using a slow-speed hand piece with a prophylaxis paste to children.
      A Frankl Behaviour Rating Score was assigned following dental prophylaxis. Children
      demonstrated a score 2 or 3 according to the Frankl Behaviour Rating Scale were selected
      [Frankl et al., 1962]. Subsequently, the patients were randomly assigned to as G1 (AB) or G2
      (BA).

      Paediatric patients were able to choose any of the 12 cartoon movies that have been approved
      by two paediatric dentists who carried out the study, checked for violence, slang language,
      and appeal to the 4-9 age range. The screen was attached to the dental unit; hence, the child
      could watch the cartoon movie clearly. While the same paediatric dentist performed all dental
      procedures in each session to remove the inter-operator variability, an independent,
      non-blinded observer recorded the data (all objective and subjective measures). Before each
      treatment session, the treatment stages were explained to the child using the tell-show-do
      technique the patient was requested to interrupt the treatment as little as possible. Parents
      were kindly requested to leave the operating room. Same treatment procedures were carried out
      in both groups during each visit in the following consecutive order. After the same topical
      anaesthesia application, mandibular block anaesthesia was performed, and followed by
      restoration treatment in lower primary molar tooth. Each visit time did not last longer than
      30 minutes. The period between V2 and V3 was two weeks, which established as a washout
      period; the patients did not receive any intervention to let the effects of the previous
      intervention diminish.

      Study Procedure Pre-operative pulse rate was retrieved by a pulse oximeter to evaluate the
      child's anxiety objectively. In addition, Venham Picture Test (VPT) was applied before the
      beginning and at the end of each visit to evaluate the child's subjective anxiety [Venham et
      al., 1981; Li and Lopez, 2005]. Eight cards, with two figures on each, represented anxious
      and non-anxious mood in the VPT. Cards were shown to the child in their numerical order and
      he/she was asked to choose the figure that felt closest to him/her at that moment. Choice of
      "anxious" figure was recorded as one, and "non-anxious" figure was recorded as zero, which
      totalled to a final score. According to the VPT, the score ranges from 0 (not anxious) to 8
      (extremely anxious).

      During the treatment, pulse rate was retrieved with the pulse oximeter at five-minute
      intervals starting from the local anaesthesia application. Moreover, the child's cooperation
      and general behaviour during treatment was rated by examiner using the Houpt Scale [Houpt et
      al., 1985].

      Cooperation and general behaviour during treatment were evaluated using the Houpt Scale
      taking into consideration the patient's reactions, and interruption of treatment. The
      following treatment phases were evaluated, and an average was calculated to determine
      patient's general behaviour score.

      Local anaesthesia application, The intraoral procedure with a high-speed rotary instrument,
      Matrix application, Restorative treatment (etch/adhesive application/polymerase/composite
      application with light-curing), Finishing. In order to evaluate pain perception during local
      anaesthesia, Sounds, Eyes and Motor Scale (SEM) scoring, which is a non-subjective method
      based on the observation of the physician, was used by the same examiner [Wright et al.,
      1991]. This method consists of two categories as comfortable (grade 1), and uncomfortable
      according to the patient's reactions. Uncomfortable responses were evaluated in three
      sub-categories: mild discomfort (grade 2), moderate discomfort (grade 3), and severe
      discomfort (grade 4).

      Following the treatment, post-operative pulse rate and VPT were repeated. Moreover, at the
      end of the dental treatment, Wong-Baker FACES Pain Rating Scale was applied to the child to
      measure the self-reported pain during treatment [Wong and Baker, 1988]. Detailed explanation
      regarding the figures of the scale was provided to the child. Six faces ranging from happy to
      crying was shown to the child and the question "How much did you hurt during the treatment?"
      was asked. Based on the self-reported answer, the score was noted to the patient form.

      Statistics Data was recorded to spreadsheets using Microsoft Excel (Microsoft Corporation.
      Redmond. WA. USA) for further analysis. NCSS (Number Cruncher Statistical System) 2007
      (Kaysville, Utah, USA) software was used for statistical analysis. While evaluating the study
      data, descriptive statistical methods (Mean, Standard Deviation, Median, Frequency, Ratio,
      Minimum, and Maximum), as well as the distribution of the data, were evaluated with the
      Kolmogorov-Smirnov Test. Mann-Whitney U test was used to compare the quantitative data
      between two groups that did not show normal distribution, and Student's t-test was used in
      case of normal distribution. Paired test in comparisons of two periods with normal
      distribution; Wilcoxon test was used for comparisons between two periods (V2, V3) that did
      not show normal distribution. Significance was evaluated at the p<0.05 level. No subgroup
      analysis was carried out in this study.
    

Intervention name(s): Behavioral guidance; Pain assessment; Dental anxiety assessment
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Conventional behavior guidance technique was used in one of the different treatment sessions with intervals of two weeks for both groups, and the cartoon-assisted distraction technique was used in the other. As a result, the effect of the cartoon-assisted distraction technique during dental treatment on behavior in pediatric patients was evaluated.; Conventional behavior guidance technique was used in one of the different treatment sessions with intervals of two weeks for both groups, and the cartoon-assisted distraction technique was used in the other. It was assessed the effect of the cartoon-assisted audio/visual distraction technique usage on paediatric patient's pain during dental care.; Conventional behavior guidance technique was used in one of the different treatment sessions with intervals of two weeks for both groups, and the cartoon-assisted distraction technique was used in the other. It was evaluated the effect of the cartoon-assisted audio/visual distraction technique usage on paediatric patient's dental anxiety during treatment sessions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: dental anxiety; pain; behavior; dental care