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临床试验/CTRI/2024/06/068296
CTRI/2024/06/068296尚未招募2/3 期

Comparative evaluation of the effectiveness of three different non-pharmacological behaviour guidance techniques during dental procedures requiring local anaesthesia in 4–9-year-old children : A randomized control trial.

All India Institute of Medical SciencesRaipur1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年6月17日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
126
试验地点
1
主要终点
Reduction in anxiety accessed using change in heart rate and sp02

研究概览

简要总结

The phenomena of dental fear and anxiety in children is a pervasive and often underestimated issue that has significant implications for both the oral health of young individuals and their overall well-being. Children may experience various levels of apprehension due to dental treatment, which may be mild and temporary, or severe and protracted, and may develop even before the scheduled visit. The amount of information that is perceived by a child depends on the cognitive development of the child.

The "Tell-Show-Do (TSD)" communication model, is regarded as the foundation of behavior control strategies. Its goal is to reduce the child’s fear by acquainting them with the dental environment. A modified version of this technique is tell-show-play doh, which makes use of the principle of learning by doing.

Learning through observation is known as modeling, and it can occur when children mimic a model’s actions in a similar circumstance. Modelling can be live modelling or filmed modelling. Research has shown that modeling can help children learn better coping mechanisms for stressful medical situations and can be a therapeutic tool for managing anxiety.

Teach back is a verbal communication strategy, is an efficient way to reinforce or provide health education to both adults and children. Combining Tell-Show-Play-Doh and teach back techniques is expected to provide the child a clear understanding of what he/she is going to be experience, and can help prepare the child for the treatment by alleviating the associated anxiety.

 JUSTIFICATION OF THE STUDY   Only limited studies are available comparing Tell-show-Play-Doh and Filmed modelling. Also, no such studies have been done combining teach back technique with Tell-Show-Play-Doh. Moreover, most of the studies have been done during preventive treatment procedure. Hence this study will be undertaken during procedures which require local anesthesia administration, for assessment of the reduction in anxiety and improvement in cooperativeness of behavior after applying the behavior modification technique

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
4.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Children between age group of 4 to 9 years Children with Frankl’s behavior rating score of 2 or 3 Children coming for first dental visit / 6 months elapsed between current and previous dental visit.
  • Children with a treatment need that requires the administration of local anesthesia Children whose parent/legal guardian give consent to participate in the study.

排除标准

  • Children with Frankl’s behavior rating score of 1 or 4 Children below 4 years of age and above 9 years of age Children with systemic,neurological,coagulopathy, psychiatric or behavioral conditions, which precludes the ability to display suitable behavior Children coming for treatment modalities not requiring local anesthesia.

结局指标

主要结局

Reduction in anxiety accessed using change in heart rate and sp02

时间窗: baseline-pretreatment | during treatment | post treatment

次要结局

  • improvement in cooperativess of child assessed using frankels behaviour rating scale(baseline-pretreatment)

研究者

发起方
All India Institute of Medical SciencesRaipur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Maneesha Babu

All India Institute of Medical Sciences, Raipur

研究点 (1)

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