The Effect of Virtual Reality on Pain, Physical Function, and Health-related Quality of Life in Children With Sickle Cell Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pain Intensity (Numeric Rating Scale - NRS)
研究概览
简要总结
Significance or rationale of the study:
Virtual reality (VR) is a promising non-pharmacological pain management tool. It enhances motor function by promoting cortical reorganization and neuroplasticity. Its multimodal biofeedback engages sensory and cognitive functions, making therapy interactive, motivating, and easy to understand. With strong rehabilitation potential, VR helps patients adapt to real-world movements (Laver, 2020). Initially used for procedural pain management, VR is now expanding into chronic pain rehabilitation by encouraging engagement with difficult or avoided movements (Griffin et al., 2020). Additionally, VR offers a dynamic alternative to traditional exercises, improving adherence and outcomes. Integrating entertainment into therapy can motivate children, enhancing their physical and psychological well-being. Recently, a few studies revealed an improvement in vaso-occlusive episodes (VOE) after VR treatment (Agrawal et al., 2019). However, efficacy studies are needed to assess VR's potential benefits. Additionally, data regarding VR's efficacy on daily pain, functional mobility, and HRQOL as complementary therapy are limited
详细描述
- To investigate the effect of VR in reducing daily pain in children with SCD
- To evaluate the impact of VR on improving functional mobility in children with SCD.
- To examine the changes in PedsQL in children with SCD after engaging in VR experiences.
- To evaluate the safety and satisfaction of fully immersive VR therapy in children with
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 (Outcomes Assessor)
盲法说明
No additional parties were masked beyond the outcomes assessor. Only the assessor responsible for measuring clinical outcomes was blinded to group allocation.
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 8 and 13 years.
- •Diagnosed with sickle cell disease (SCD), including homozygous SCA and other clinically confirmed variants.
- •Medically stable and cleared by the treating physician to participate in mild activity.
- •Receiving hydroxyurea as part of routine care.
- •Able to follow simple instructions and communicate pain levels.
- •Parental/legal guardian consent and child assent obtained.
排除标准
- •Presentence of developmental, neurological, or genetic disorders.
- •History of hip replacement or major orthopedic conditions affecting mobility.
- •Current acute chest syndrome or unstable clinical condition.
- •Visual or hearing impairments that would interfere with VR use.
- •Participation in concurrent physiotherapy or rehabilitation programs.
- •Previously enrolled in phase one of the current study (if applicable)
结局指标
主要结局
Pain Intensity (Numeric Rating Scale - NRS)
时间窗: Baseline, Week 3, and Week 5
Pain intensity was assessed using the validated Arabic version of the Numeric Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Participants were asked to rate their pain immediately before and after the VR session to measure the short-term analgesic effect of the intervention.
次要结局
- Health-Related Quality of Life (PedsQL)(Baseline, Week 3, and Week 5)
- Functional Mobility (Timed Up and Go Test - TUG)(Baseline, Week 3, and Week 5)
研究者
Afnan Bkri
Physiotherapist
Ministry of Health, Saudi Arabia