跳至主要内容
临床试验/NCT03951155
NCT03951155Unknown不适用

Effectiveness of Relaxation Technique (Muscle Relaxation) for Behavioral Management of ADHD Children During Dental Treatment. (Randomized Clinical Trial)

Cairo University0 个研究点目标入组 40 人开始时间: 2019年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
Modified Frankl Scale for child cooperation

研究概览

简要总结

Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment.

详细描述

Evaluation of effect of relaxation technique (Muscle Relaxation) on behavioral management and anxiety control of ADHD children during dental treatment compared to Tell Show Do technique (control group) using modified Frankl scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessor responsible for evaluating child behavior & cooperation will be masked

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children: 6 to 9 years old ADHD children
  • Teeth: Teeth requiring dental treatment or preventive measure.

排除标准

  • Non ADHD children.
  • ADHD children having allergy to local anaesthesia or systemic problem that contraindicate dental treatment.
  • Refusal of participation

研究组 & 干预措施

ADHD Group

Experimental

Muscle Relaxation technique for behavioral management

干预措施: Muscle Relaxation (Behavioral)

Tell Show Do Group

No Intervention

Tell Show Do Technique for behavioral management

结局指标

主要结局

Modified Frankl Scale for child cooperation

时间窗: one day

Rating 1: DEFINITLY NEGATIVE (--): Refusal of treatment, crying forcefully, fearful, or any other overt evidence of extreme negativism. * Rating 2: NEGATIVE (-): Reluctant to accept treatment, uncooperative, some evidence of negative attitude but not pronounced, i.e. sullen, withdrawn. * Rating 3: NEGATIVE POSITIVE (-+): Fluctuation between uncooperativeness and some evidence of unpronounced negative attitude, and cautious acceptance to treatment with reservation shifting throughout the visit. * Rating 4: POSITIVE (+): Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively. * Rating 5: DEFINITLY POSITIVE (++): Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation.

次要结局

  • Completion of treatment(one day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nouran Khalifa Hamed

Principle investigator

Cairo University

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