Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care : A Pilot Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility( the response rate of recruitment) using immersive VR during immunization in children,
研究概览
简要总结
Paediatric immunization is often associated with significant fear and anxiety among children and their parents. Their distress can greatly affect their future adherence to the immunization schedule and the acceptance of recommended vaccines by physicians. This pilot was a single-centre, open label, randomised controlled trial to examine the use of VR analgesia in childhood immunization in primary care.The study primarily aimed to determine the feasibility of using immersive virtual reality (VR) during immunization in children by assessing the response rate of the participants during recruitment. The secondary outcome of the study was to determine the effectiveness of immersive VR in alleviating pain and anxiety among children during immunization compared to usual care without VR. It also aimed to determine the effectiveness of immersive VR in reducing anxiety among the parents and nurses during immunization procedure.
详细描述
This study primarily aimed to determine the feasibility of using immersive VR during immunization in children. The response rate of the recruitment was the feasibility assessment on whether children and parents were acceptable to the VR usage during immunization. The secondary outcome mainly focused on the clinical and safety outcomes of using immersive VR during immunization in preparation towards a larger randomized control trial. The secondary outcome of the study was the change in children's pain and anxiety scores using the Faces Pain Scale-Revised (FPS-R) and Children's Fear Scale (CFS) pre- and post-immunization. The other secondary outcome were the change in parent's and nurse's anxiety score using the Anxiety visual analogue scale (VAS).The nurses' acceptability, simplicity and willingness to use VR during immunization were also assessed in the study. Adverse events such as premature termination due to VR side effects in the children were also reported.
This pilot was a single-centre, open label, randomised controlled trial that was conceptualized as a proof of concept study to examine the use of VR analgesia in childhood immunization in primary care.
Study Setting and Population:
This study was conducted at a regional public primary care clinic (polyclinic) in Sengkang, which serves a population of about 240,000 inhabitants - of which children under the age of 9 years old account for 14.5% of them (second highest paediatric population in Singapore).The study populations included multi-ethnic Asian children aged 4 to 10 years, their parents and the registered nurses who administered their immunization at the polyclinic.
Sample Size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of both gender and of any ethnicity are eligible to participate.
- •Parent (father or mother) or legal guardian or legal representative of the above children who accompany them to the polyclinic for immunization.
- •Registered nurses who are assigned to the immunization service stations during the period of the study.
排除标准
- •Children who are diagnosed with any disability or are deemed incapable of providing assent to the study will be excluded.
- •Children with pre-existing epilepsy/seizure or migraine
- •Caregivers including domestic helpers, grandparents, other relatives or nannies will be excluded.
- •Parent (father or mother) or legal guardian or legal representative who are affected by any disability which renders them incapable of providing consent will also be excluded.
- •Enrolled nurses or relief registered nurses at the study site will be excluded.
结局指标
主要结局
Feasibility( the response rate of recruitment) using immersive VR during immunization in children,
时间窗: within 10 minutes
Response rate of recruitment (number of participants agree to participate divided by the total number of screened participants, expressed in % )
次要结局
- Change in parent's anxiety score, using Anxiety Visual Analogue Scale(VAS)(30 mins ( assess before and after immunisation))
- Change in nurses anxiety score, using Anxiety Visual Analogue Scale(VAS)(30 mins ( assess before and after immunisation))
- Simplicity of VR application during immunization by nurses(5 mins)
- Acceptability to VR application during immunization by nurses(5 mins)
- Willingness to use VR application in the future by nurses(5 mins)
- Change children's pain score, using Faces Pain Scale-Revised (FPS-R)(30 mins ( assess before and after immunisation))
- Change in children's anxiety score, using Children's Fear Scale (CFS)(30 mins ( assess before and after immunisation))
研究者
Chang Zi Ying
Principal Investigator, Deputy Clinic Director (SingHealth Polyclinic-Punggol branch)
SingHealth Polyclinics