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临床试验/CTRI/2025/02/080268
CTRI/2025/02/080268尚未招募2/3 期

Comparative Evaluation Of Acupressure And Virtual Reality Distraction For Anxiety Reduction In Children Aged 8-12 Yrs – A Randomized Control Trial.

Dr Kanchan M Tuppadmath1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年2月19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
60
试验地点
1
主要终点
evaluate and compare effect of acupressure and virtual reality distraction on anxiety levels in children receiving local anesthesia in dental setting.

研究概览

简要总结

Background: Anxiety is an obstacle during dental treatment in children. Acupressure and Virtual reality distraction (VRD) are the newer behaviour modification techniques currently gaining popularity in clinical Pediatric Dentistry. The purpose of this study is to compare the effect of acupressure and VRD on anxiety in children.

Methods: A total of 60 children aged 8-12 years meeting inclusion criteria will be randomly and equally divide into acupressure (group I) and VRD group (group II). Acupressure group is further subdivided into three groups with 10 subjects in each subgroup based on the acupoints selected (EX-HN3, Shen Men, P6). Acupressure beads with adhesive strip will be employed over the selected acupoints for group I and VRD glasses playing cartoons will be put on for group II. Anxiety will be measured at four different time intervals i.e at baseline, forty minutes after application of acupressure in group I and five minutes after using virtual reality device in group II, five minutes after local anesthesia, lastly fifteen minutes after completion of treatment. Modified child dental anxiety scale faces version (MCDAS [F]) was used for subjective assessment, Venham’s clinical anxiety rating scale (VCRS) for objective assessment and pulse rate (PR) as physiologic assessment.

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
8.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children aged 8-12 years, requiring administration of local anesthesia irrespective of treatment with a Frankl’s rating 2 and 3 and good general health (American society of Anaesthesiology I).

排除标准

  • children with special health care needs, medically compromised and who have history of anxiety disorders and phobia.

结局指标

主要结局

evaluate and compare effect of acupressure and virtual reality distraction on anxiety levels in children receiving local anesthesia in dental setting.

时间窗: for acupressore- 45 minutes before local anesthetia, 5 minutes after local anesthesia and 15 minutes after treatment completed

次要结局

  • side effects following intervention with acupressure and virtual reality distraction(15 minutes after treatment procedure is complete)

研究者

发起方
Dr Kanchan M Tuppadmath
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Kanchan M Tuppadmath

AMEs dental college and hospital

研究点 (1)

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