Use of Virtual Reality to Improve Pain and Anxiety Management of Children During Dupilumab Injection for Atopic Dermatitis (VR-DERMA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- mean difference in pain intensity score between sequences
研究概览
简要总结
The aim of this within-subject randomized study is to examine the efficacy of a VR immersive game for pain and anxiety management of children during the subcutaneous injection of dupilumab for moderate to severe atopic dermatitis. We will recruit children from 6 to 17 years.
The main research question is:
- Does VR immersive game will generate less anxiety and pain than standard procedures, for children receiving dupilumab injection for moderate to severe atopic dermatitis?
- Does the occurence of side effects is similar between both study groups?
Participants will be randomized according to either sequences: VR-Standard care or Standard care-VR. During the VR sequence, participants will be playing the VR immersive game during the injection. During the Standard care sequence participants will not benefit from any pain management but passive distraction tools will be offered (and documented) to children.
The investigators will take measures of pain and anxiety, using validated scales, before and after the procedures at each sequence.
详细描述
Background :
Atopic dermatitis is one of the most common inflammatory diseases of the skin and usually starts in early childhood.The prevalence of atopic dermatitis ranges from 15 to 20% among children and up to 10% in adults. Atopic dermatitis treatment has been revolutionized in the past years with the approval of dupilumab (Dupixent®, Sanofi) in recent years for children. Dupilumab subcutaneous injections are highly effective in our real-world setting. However, pain at the site of injection is often reported by the parents and the patients. Regardless of the site of injection or the injection device being used, the injection remains difficult mainly because of the anxiety generated before the procedure and the anticipated pain, even if the injection only lasts five seconds.
In addition, many strategies have been unsuccessfully attempted to improve the injection experience, for example numbing cream or anxiolytic administration prior to the injection. A few authors have studied the effect of Virtual Reality (VR) on procedural pain and anxiety management. Indeed, a review of the literature has yielded only three studies who used VR with burn children. One study has verified the efficacy of VR compared to standard pharmacological care in an RCT on 54 children (6 to 19 years) suffering from burn-related injuries with TBSA (Total Body Surface Area) varying from 1 to 50%. Results showed better pain control and maximum Range of Motion (ROM) of children in the VR group.
Finally, considering the lack of optimal pain and anxiety management during dupilumab subcutaneous injections for a subset of pediatric patients, and the positive effect of an immersive distraction method such as VR for painful procedures, using VR for dupilumab injections may show promising results. To our knowledge, no other studies have tested the effect of an immersive distraction such as VR for procedural pain and anxiety management in children suffering from atopic dermatitis receiving subcutaneous injections of dupilumab.
Aim of the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between the ages of 6 to 17 years old,
- •suffering from moderate to severe atopic dermatitis and receiving or about to start subcutaneous injections of dupilumab,
- •in the presence of a consenting parent who can understand, read, and write either French or English.
排除标准
- •have a diagnosed cognitive impairment precluding them from playing a virtual reality game,
- •suffer from epilepsy considering the nature of the intervention,
- •cannot be in a sitting position during the procedure as the virtual reality game requires an angle of at least 30 degrees for head-tracking.
结局指标
主要结局
mean difference in pain intensity score between sequences
时间窗: Immediately after the procedure on day 1 and a week later on day 2 (T2 and T4) (self-report of pain levels during the procedure).
Pain intensity will be assessed using the Numerical Rating Scale (NRS) for children 6 years and older. The NRS is an 11-item scale for pain intensity ranging from 0 to 10; 0=no pain to 10= worst pain ever felt.
mean difference in anxiety between sequences
时间窗: Immediately after the procedure on day 1 and a week later on day 2 (T2 and T4) (self-report of anxiety levels during the procedure).
The level of anxiety will be assessed using the Child Fear Scale (CFS). It consists of five faces ranging from 0 (no fear/anxiety) through 4 (extremely fearful/anxious). The child is asked to indicate which face shows best how he/she felt during the procedure.
次要结局
- healthcare professionals' satisfaction levels(Reported immediately after the sequence, a week later on day 2 (T4))
- parents' satisfaction levels(Reported immediately after the sequence a week later on day 2 (T4))
- Mean difference in cognitive, affective and sensory components of pain as well as sense of presence in VR and engagement into the game between groups(Reported immediately after the procedure on day 1 and a week later on day 2 (T2 and T4))
- children's satisfaction levels(Reported immediately after the procedure on day 1 and a week later on day 2 (T2 and T4))
- Occurrence of adverse events(Reported immediately after the procedure on day 1 and a week later on day 2 (T2 and T4))
研究者
Sylvie Le May
Principal Investigator
St. Justine's Hospital