The Effect of a Kaleidoscope and Cartoons on Pain and Anxiety Associated With Local Anesthetic Injection for Dental Treatment in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Pain level during local anesthesia injection measured using the Wong-Baker FACES Pain Rating Scale
研究概览
简要总结
Dental fear and anxiety are among the most common challenges encountered in pediatric dental practice and may negatively affect children's cooperation and acceptance of dental treatment. Local anesthesia injections are considered one of the main sources of pain and anxiety during dental procedures in children. Although pharmacological methods can be effective in managing pain and anxiety, they may not always be preferred due to potential side effects, limited applicability, and the possibility of increasing stress in children. Therefore, non-pharmacological behavioral management techniques, particularly distraction methods, are increasingly used in pediatric dentistry to reduce pain perception and anxiety.
The aim of this randomized controlled trial is to evaluate the effects of kaleidoscope use and cartoon distraction on pain, fear, and anxiety associated with local anesthesia injections in children undergoing dental treatment. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University. A total of 126 children aged between 7 and 12 years who require local infiltration anesthesia during dental treatment will be included in the study. Participants will be randomly assigned to one of three groups: the Kaleidoscope Group, the Cartoon Distraction Group, or the Control Group. Children in the kaleidoscope group will use a kaleidoscope during the local anesthesia injection, while children in the cartoon group will watch cartoons during the procedure. In the control group, local anesthesia will be administered according to the routine clinical procedure without any distraction technique.
Pain, fear, and anxiety levels will be assessed using the Wong-Baker FACES Pain Rating Scale, the Children's Fear Scale, and the Children's Anxiety Scale-State. Behavioral responses will also be evaluated using the Frankl Behavior Rating Scale. The findings of this study are expected to provide evidence regarding the effectiveness of simple and non-pharmacological distraction techniques in reducing pain and anxiety associated with local anesthesia injections in pediatric dental patients.
详细描述
Dental fear and anxiety are common in pediatric dentistry and can negatively affect children's cooperation and acceptance of treatment. Local anesthesia injections are a major source of pain and anxiety in children during dental procedures. While pharmacological methods may be effective in managing pain and anxiety, non-pharmacological behavioral techniques, particularly distraction methods, are increasingly used to reduce discomfort.
This randomized controlled trial aims to evaluate the effects of two distraction techniques-kaleidoscope use and cartoon viewing-on pain, fear, and anxiety associated with local anesthetic injections in children undergoing dental treatment. The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Dicle University.
A total of 126 children aged 7-12 years who require local infiltration anesthesia will be included. Participants will be randomly assigned to one of three groups: Kaleidoscope Group, Cartoon Distraction Group, or Control Group. Children in the Kaleidoscope Group will use a kaleidoscope during the injection, while children in the Cartoon Group will watch cartoons. In the Control Group, injections will be administered according to routine clinical procedures without distraction.
Pain, fear, and anxiety will be assessed using the Wong-Baker FACES Pain Rating Scale, the Children's Fear Scale, and the Children's Anxiety Scale-State. Behavioral responses will be evaluated with the Frankl Behavior Rating Scale. Data collection will occur during the dental procedure and immediately after the injection.
This study is expected to provide evidence on the effectiveness of simple, non-pharmacological distraction techniques in reducing pain and anxiety in pediatric patients undergoing local anesthesia injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged between 7 and 12 years
- •Children requiring local infiltration anesthesia for dental treatment
- •Children who apply to the Pediatric Dentistry Clinic of Dicle University Faculty of Dentistry
- •Children and their parents who voluntarily agree to participate in the study and provide informed consent
- •Children with positive or definitely positive behavior according to the Frankl Behavior Rating Scale
排除标准
- •Children with chronic diseases
- •Children with a history of hospitalization or surgery
- •Children with neurological or behavioral disorders such as autism, attention deficit hyperactivity disorder (ADHD), or learning disabilities
- •Children with mental retardation, hearing impairment, or speech problems
- •Children with dental abscesses or fistulas
研究组 & 干预措施
Kaleidoscope Group
Children in this group will use a kaleidoscope during the administration of local infiltration anesthesia as a visual distraction technique. The child will be instructed on how to use the kaleidoscope before the injection and will continue using it throughout the procedure
干预措施: Kaleidoscope Distraction (Behavioral)
Cartoon Distraction Group
Children in this group will watch cartoons as an audiovisual distraction technique during the administration of local infiltration anesthesia. The cartoon will be started before the injection and will continue throughout the procedure.
干预措施: Cartoon Distraction (Behavioral)
Control Group
Children in this group will receive local infiltration anesthesia according to the routine clinical procedure without the use of any distraction technique.
结局指标
主要结局
Pain level during local anesthesia injection measured using the Wong-Baker FACES Pain Rating Scale
时间窗: Immediately after the local anesthesia injection
Pain perception during the administration of local anesthesia will be assessed using the Wong-Baker FACES Pain Rating Scale. The scale consists of six facial expressions representing increasing levels of pain, scored from 0 (no pain) to 10 (worst pain). Children will be asked to select the face that best represents the pain they experienced during the injection.
次要结局
- Fear level during local anesthesia injection measured using the Children's Fear Scale(Immediately before and immediately after the local anesthesia injection)
- Anxiety level measured using the Children's Anxiety Scale-State (CAS-S)(Immediately before and immediately after the local anesthesia injection)
- Child behavior during dental treatment measured using the Frankl Behavior Rating Scale(During the local anesthesia administration procedure)
研究者
Elif Bilsin Kocamaz
Associate Professor
Dicle University