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临床试验/NCT06153823
NCT06153823招募中不适用

Effectiveness of Virtual Reality Glasses Integrated With Sign Language on Dental Anxiety Among Children With Hearing Impairment During Pulpotomy Procedure (Randomized Controlled Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Change in child anxiety level

研究概览

简要总结

To evaluate the impact of using virtual reality glasses using sign language as a distraction method to reduce the dental anxiety in moderate to severe hearing-impaired children compared to the conventional behavior management technique during pulpotomy treatment.

The study will be a randomized controlled parallel two arms clinical trial, a total of 40 healthy children aged 5-7 years with moderate to severe hearing disability, will be selected from Pediatric Dentistry and dental public health Department, Faculty of Dentistry, Alexandria University, Egypt. Children selected should have at least one primary molar indicated for pulpotomy. The eligible participants will be randomly assigned to one of two groups: the study group, which will use virtual reality glasses with sign language as a distraction method to manage children's behavior, and the control group, which will use the conventional behavior management strategies including show-tell-do, and positive reinforcement. Local anesthesia will be given and pulpotomy procedure will be done on the selected tooth followed by stainless steel crown restoration. Pre and post-operative assessment of child's dental anxiety will be done using three methods: physiologically using pulse oximeter for measuring the heart rate, objectively using Venham clinical anxiety rating scale, and subjectively using the modified facial image 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 (Participant)

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children with Frankl behavior rating score 2 or
  • •Children requiring pulpotomy in one of their primary molars.
  • •Parents who accepted to give their consent and participate in the study.

排除标准

  • •Children with any medical condition other than hearing disability (ASA II, III & IV).
  • •Syndromic children with hearing impairment.
  • •Children with previous bad dental experience.

研究组 & 干预措施

show-tell-do technique.

Active Comparator

干预措施: Tell Show and Do (Other)

virtual reality glasses

Experimental

干预措施: virtual reality glasses (Other)

结局指标

主要结局

Change in child anxiety level

时间窗: up to 2 months

This objective measure scores the child's level of anxiety with a correlating behavior description It consists of 6 categories (range from 0 to 5) where 0= relaxed, 1=uneasy, 2= tense, 3= reluctant, 4= interference, 5= out of contact.

次要结局

  • Change in child anxiety level by subjective method(up to 2 months)
  • Change in heart rate(up to 2 months)

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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