The effectiveness of an interactive toy as an active distraction in alleviating dental anxiety and pain while administration of local anesthesia in children - a randomized clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the effectiveness of interactive toy with colourful headset in reducing dental anxiety among children
研究概览
简要总结
Effective paincontrol during dental treatment of a paediatric patient is the cornerstone forsuccessful behaviour guidance. Researchers have found that one of the most provocation aspects of child behaviourmanagement is poor pain control. Avariety of behavioural management techniques has emerged to manage dental fearincluding pharmacological and non-pharmacological methods. Previousstudies have stated that use of distraction during dental treatment is usefulto patients by reducing their distress and in turn decrease their perception ofpain sensation especially during injections with local anesthesia. Previousstudies have stated that use of distraction during dental treatment is usefulto patients by reducing their distress and in turn decrease their perception ofpain sensation especially during injections with local anesthesia. Active forms ofdistraction promote a child’s participation involving several sensorycomponents such as interactive toys, virtual reality, controlled breathing,guided imagery and relaxation; conversely, passive forms achieve distractionthrough a child’s observation of an activity or stimulus rather than theirexplicit partaking for example listening to music, watching television.
Aim : The aim of the study is to evaluate the effect of an interactive toy as a distraction technique in reducing the dental anxiety and pain while administration of local anesthesia in children aged 4-9 years.
Objectives : To assess the effect of an Interactivetoy as an active distraction in reducing dental anxiety and pain whileadministration of local anesthesia.
· To assess the effect of a colourfulheadset with music as a passive distraction in reducing dental anxiety and painwhile administration of local anesthesia.
· Tocompare the effectiveness of an Interactive toy and Colorful headset with musicwhile administration of local anesthesia.
Methodology : The presentstudy will be a randomized clinical trial using block randomisation and areequally allocated into 1:1 ratio.
Childrenaged 4-9 years will be included in the study and they will be divided into twogroups.
Group 1: Children will be given interactivetoy as an active distraction.
Group 2: Children will be given colourfulheadset with music as a passive distraction.
The reactionof children during local anesthesia administration (Infiltration) will berecorded in terms of anxiety (Modified Venham Picture scale and pulse rate),and pain perception (Modified Wong-Baker FACES pain rating scale and the Faces,Leg, Activity, Cry and Consolability scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Children age group of 4-9 years 2.Healthy children attending the dental hospital 3.Children who are willing to participate and are able to understand and reply to the questionnaire.
- •Children indicated for dental procedures under local anesthetia.
排除标准
- •Children with special health care needs.
- •Children with systemic disorders.
- •3.Children with dental emergency which include trauma,acute pulpitis, dental abscess, cysts, pericoronitis etc.
结局指标
主要结局
To compare the effectiveness of interactive toy with colourful headset in reducing dental anxiety among children
时间窗: Baseline | During administration of LA | After administration of LA
次要结局
- To compare the effectiveness of interactive toy with colourful headset in reducing pain among children(Before admnistration of LA)
