Effectiveness of an active and passive distraction technique on the anxiety, behavior and pain levels of children while administering local anesthesia: a randomized clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Dental anxiety of the child to be measured before and after the administration of Inferior alveolar nerve block using Modified Child Dental anxiety scale faces version [MCDAS(f)].
研究概览
简要总结
Aim:
To evaluate and compare the effectiveness of stress ball(active) distraction technique and audiovisual eyeglasses (passive) distraction technique on the pain, behavior and anxiety levels during administration of inferior alveolar nerve block.
Objective:
1. To evaluate the change in the behavior, anxiety and pain levels in children after the use of the distraction techniques during the administration of inferior alveolar nerve block.
- To compare the behavior, anxiety and pain levels between the children after use of active and passive distraction techniques during the administration of inferior alveolar nerve block.
Methodology:
All procedures were done in the presence of parents/guardians. In order to acclimatize the child to the dental clinic, basic behaviour guidance techniques like communication, tell-show-do, and verbal reinforcement were for all the participants. The
children were randomly assigned to one of the groups using block randomization method with 1:1:1 allocation ratio:
Group 1: Conventional method of Communication
Group 2: Virtual Reality glasses
Group 3: Stress ball
Prior to administration of the local anesthetic agent, dental anxiety of the child was measured using the MCDAS(f) scale. Behavior was assessed during the entire length of the procedure using the Venham behavior scale. Each child was asked to quantify the pain felt during the injection using the Wong-Baker faces pain rating scale. The pain reaction was also recorded by an observer using FLACC scale ( Faces Legs Activity Cry and Consolability scale). The variations in the pulse rate was recorded using pulse oximeter, at three time points: just before starting the administration of the local anesthetic, during the injection of the local anesthetic and soon after the removal of the needle from the tissue. Scoring for behavior and pain was done using a video recording of the procedure by two examiners.
A questionnaire consisting of questions on the history of earlier dental visit (first visit or not), past dental and medical experiences of the child, socioeconomic status, parental anxiety and temperament of the child was administered to the accompanying parent prior to the procedure.
Results and Conclusions: There was no significant difference between the groups for all the outcomes (dental anxiety, behaviour and pain levels). Significant decrease in anxiety was seen within all the groups after the behaviour guidance. The effect of passive distraction (AV eyeglasses) and active distraction (stress ball) on the anxiety, behaviour and pain levels during administration of the inferior alveolar nerve block are comparable to the conventional behaviour guidance methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with a score of ≥12 on faces version of Modified Child Dental Anxiety Scale.
- •Children who could be categorized under positive (+) ratings of Wright’s modification of Frankl behavior rating scale (Wright and Stigers 2011).
- •Children who require extraction/pulp therapy/restoration for deep carious lesion treatment in lower primary and first permanent molars under local anesthesia (inferior alveolar nerve block).
排除标准
- •1.Children suffering from any systemic and/or mental illness.
- •2.Children whose parents do not give written informed consent or children who do not give assent for the study 3.Children who have undergone any dental treatment under local anesthesia in the past 6-7 weeks.
结局指标
主要结局
Dental anxiety of the child to be measured before and after the administration of Inferior alveolar nerve block using Modified Child Dental anxiety scale faces version [MCDAS(f)].
时间窗: Before and after the administration of Inferior alveolar nerve block using Modified Child Dental anxiety scale faces version [MCDAS(f)].
次要结局
- Behavior and pain of the child to be measured before and after the administration of Inferior alveolar nerve block using Venham Behaviour rating scale and Wong Baker and FLACC scale respectively.(Before and after the administration of Inferior alveolar nerve block.)