A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Dental Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Post Procedure Pain using the Faces Pain Scale - Revised
研究概览
简要总结
Children sometimes need dental procedures which can be painful and associated with child pain and anxiety. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames.
Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.
This study will randomize children (4 - 16 years old) to receive Virtual Reality or standard of care in addition to local anesthetics during dental procedures. Pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. Outcome measures will be compared between the two groups.
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
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 4 to < 17 years
- •Arriving to the UBC dentistry clinic and need dental assessment/procedures
- •Parents will sign a consent form and children will sign an assent form
排除标准
- •Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, challenging communication)
- •Facial features prohibiting wearing the VR goggles
- •Children needing sedation that includes inhalation via a mask (N2O) or IV/IM sedation
研究组 & 干预措施
Virtual Reality
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during the dental procedure
干预措施: Virtual Reality (Device)
Control (Standard of Care)
Participants are distracted with Standard-of-Care by dentists and/or parents.
结局指标
主要结局
Post Procedure Pain using the Faces Pain Scale - Revised
时间窗: Pain is reported by children immediately following completion of the procedure (within two minutes post-procedure). This scale should take less than one minute to complete
Level of pain as reported by children using Faces Pain Scale - Revised. The scale includes six faces that represent progressively more intense features of pain. Children point to the face that best represents their current level of pain. The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain). The scale increase in increments of 2.
次要结局
- Post Local Anesthetic Pain using the Faces Pain Scale - Revised(Pain is reported by children immediately following injection of the local anesthetic (within two minutes post-injection). This scale should take less than one minute to complete)
- Parent Satisfaction determined qualitatively by an open ended question(Satisfaction question is reported by parents immediately following completion of the dental procedure)
- Patient Satisfaction determined qualitatively by an open ended question(Satisfaction question is reported by children immediately following completion of the dental procedure)
- Anxiety using the Venham Situational Anxiety Score(Anxiety is reported by children immediately following completion of the procedure (within two minutes post-procedure). This scale should take less than one minute to complete)
- Co-operation of the child as measured by the Dentist on 100mm VAS(Co-operation is rated immediately following completion of the dental visit.)
研究者
Ran Goldman
Professor and Co-head of the Division of Clinical Pharmacology, Division of Emergency Medicine, Department of Pediatrics; Investigator, BC Children's Hospital
University of British Columbia