Cartoon-assisted Visual/Auditory Distraction Usage in Paediatric Dental Care, Assessment of Resulting Effects on Patient Anxiety, Pain, and Behaviour.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Child's anxiety assessment (objective)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients without any previous dental treatment experience.
- •Children who required restorative treatment in lower primary molars (pulpotomy, pulp capping, composite filling) under local anaesthesia.
- •A score of 2 or 3 according to the Frankl Behaviour Rating Scale following the oral prophylaxis in the initial appointment.
排除标准
- •Systemic disease and related continuous drug use.
- •Mental and cognitive disorders, visual and auditory disabilities.
- •Children demonstrated "definitely negative" or "definitely positive" behaviour (Frankl 1 or 4) following the oral prophylaxis in the initial appointment.
结局指标
主要结局
Child's anxiety assessment (objective)
时间窗: Changes in pulse rate over 5-minute periods during procedure
Pulse oximeter was used for objective outcomes of child's anxiety.
Child's pain assessment (objective)
时间窗: The first 3 minutes of the dental treatment, Sounds, Eyes and Motor Scale (SEM) scoring was used for objective outcomes.
Sounds, Eyes and Motor Scale (SEM) scoring used for objective outcomes. 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).
Child's cooperation assessment
时间窗: Observation was done for Houpt Scale scoring for 30 minutes (during the whole procedure).
The child's cooperation and general behaviour during treatment was rated by using the Houpt Scale. The Houpt Scale taking into consideration the patient's reactions, and interruption of treatment. The following treatment phases were evaluated (a-Local anaesthesia application, b-The intraoral procedure with a high-speed rotary instrument, c-Matrix application, d- Restorative treatment (etch/adhesive application/polymerase/composite application with light-curing), e-Finishing), and an average was calculated to determine patient's general behaviour score (1-5, higher scores mean worse outcome).
Child's anxiety assessment (subjective)
时间窗: Change of the results of baseline Venham Picture Test compared to the end of treatment procedure up to 1 hour
Venham Picture Test (VPT) was used for subjective outcomes of child's anxiety. 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).
Child's pain assessment (subjective)
时间窗: 5 minutes after the end of dental treatment, Wong-Baker FACES Pain Rating Scale was applied to the child to measure the self-reported pain perception.
Wong-Baker FACES Pain Rating Scale was used for subjective outcomes. 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.
次要结局
未报告次要终点
研究者
Nilüfer Üstün
Assistant Professor
Istanbul Medipol University Hospital