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临床试验/NCT06794788
NCT06794788已完成不适用

Effect of Immersive Virtual Reality on Pain in Different Dental Procedures in Children

King Abdullah University Hospital1 个研究点 分布在 1 个国家目标入组 154 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
状态
已完成
入组人数
154
试验地点
1
主要终点
The Wong-Baker Faces

研究概览

简要总结

the current study aims to assess virtual reality as an effective pain management technique for children undergoing different dental procedures.

The iWear is the immersive virtual reality device was used for this study from (Vuzix®, Rochester, New York, USA). The iWear consists of a lightweight high-end pair of video headphones that contain pair of VR goggles

详细描述

The peadiatric dentist examined children to assess their needs. At the screening, a full mouth oral examination was performed. Different dental procedures needed were determined based on the outcome of the clinical examination performed. Some of these dental procedures did not require administration of local anesthesia (LA), such as fissure sealant, space maintainer, fluoride therapy, impression taking for space maintainers, and scaling. Other dental procedures require the administration of LA , such as stainless-steel crown, pulp therapy, restorations, and extraction (Figure 2). The peadiatric dentist divided the children into two groups (Group A & B) according to the need for usage of LA. The children with dental procedures not requiring administration of LA were assigned to Group A, and the children with dental procedures requiring administration of LA were assigned to Group B. A computer-generated random number was used to randomly divide the children in Group A into two sub-groups(Group A1 & A2) according to the usage of VR. Patients included in Group A1 randomly assigned to receive no VR. On the other hand, patients included in Group A2 randomly assigned to receive VR. Also, children in Group B were randomly assigned into two sub-groups (Group B1 & B2) to receive no VR or VR respectively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
5 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children aged 5-12 years
  • •Good general health,
  • •Taking no medications,
  • •Willingness to participate in the study

排除标准

  • •Subjects with a convulsive disorder,
  • •Subjects with a history of serious vestibular abnormalities,
  • •Subjects with musculoskeletal disorders, or developmental delay taking psychotropic drugs

研究组 & 干预措施

GROUP A1

No Intervention

The children with dental procedures not requiring administration of LA were assigned to Group A. Divide the children in Group A into two sub-groups(Group A1 & A2) Patients included in Group A1 randomly assigned to receive no VR

GROUP A2

Experimental

The children with dental procedures not requiring administration of LA were assigned to Group A. Divide the children in Group A into two sub-groups(Group A1 & A2) Patients included in Group A2 randomly assigned to receive VR-The iWear

干预措施: VR-The iWear (Device)

GROUP B1

No Intervention

the children with dental procedures requiring administration of LA were assigned to Group Divided the children in Group B into two sub-groups (Group B1 & B2) Patients included in Group B1 randomly assigned to receive no VR

GROUP B2

Experimental

the children with dental procedures requiring administration of LA were assigned to Group Divided the children in Group B into two sub-groups (Group B1 & B2) Patients included in Group B2 randomly assigned to receive VR-The iWear

干预措施: VR-The iWear (Device)

结局指标

主要结局

The Wong-Baker Faces

时间窗: through study completion, an average of 2 years

used to measure the level of pain in the current study. The Wong-Baker Faces is a self-report measure that consists of six cartoon faces with different facial expressions. The Wong-Baker Faces scale starts from zero to 10

Visual Analog Scale (VAS)

时间窗: through study completion, an average of 2 years

The VAS is a self-report measure that consists of a 10-centimeters horizontal line that indicates the current level of pain. The children were asked to give ratings using 0-10 scales with lower numbers indicates less pain, while the higher numbers indicate higher pain.

The 'Face, Legs, Activity, Cry, Consolability' (FLACC) scale

时间窗: through study completion, an average of 2 years

s a behavioral pain observation scale used commonly to measure pain during a procedure. The FLACC are reliable and valid common pain measurement tool used as an external evaluator to measure procedural pain. Each category is scored on a 0-2 scale, resulting in a total 0-10 score. The external evaluator used a 0-10 scale, with cut points indicating (0) Relaxed, (1-3) Mild discomfort, (4-6) Moderate pain, or (7-10) Severe discomfort/pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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