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临床试验/NCT07737886
NCT07737886尚未招募不适用

Feasibility, Acceptability, and Preliminary Effects of Virtual Reality for Pain, Anxiety and Recovery Enhancement of Children Post-Scoliosis Surgical Repair: A Pilot Randomized Controlled Parallel Trial (VR-SPINE)

St. Justine's Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Recruitment Rate

研究概览

简要总结

Adolescent idiopathic scoliosis is the most common spinal deformity in adolescents and frequently requires surgical intervention when curvature becomes severe. Although surgical correction improves long-term outcomes, the immediate postoperative period is often characterized by significant pain and anxiety, particularly during early mobilization, which can delay participation in physiotherapy and recovery. Virtual reality (VR) has emerged as a promising non-pharmacological intervention for reducing pain and anxiety in pediatric medical settings through immersive distraction and guided engagement.

The VR-SPINE study is a mixed-methods pilot randomized controlled trial designed to evaluate the feasibility, acceptability, and preliminary clinical effects of a VR-based intervention during early postoperative mobilization in adolescents undergoing scoliosis surgery. 24 participants aged 10-17 years undergoing corrective scoliosis surgery will be recruited at CHU Sainte-Justine and randomized to either VR plus standard postoperative care or standard care alone. The VR intervention consists of a collaborative therapeutic game played during the first postoperative mobilization to an armchair, designed to promote relaxation, distraction, and engagement with physiotherapy.

Primary outcomes include the feasibility of recruitment and implementation, as well as acceptability and satisfaction among participants and healthcare professionals. Secondary outcomes include postoperative pain, anxiety, tolerance to mobilization, analgesic use, and adverse effects. Qualitative interviews with a subset of participants and healthcare professionals will further explore perceived barriers, facilitators, and the clinical experience of using VR during early recovery.

详细描述

BACKGROUND Adolescent idiopathic scoliosis is a three-dimensional spinal deformity of unknown cause. It is often called 'adolescent' because it is most commonly diagnosed during adolescence. However, scoliosis can be viewed as a condition that exists from birth through adulthood and can be identified at any age. Idiopathic scoliosis is the most common spinal deformity seen in adolescents over 10 years old, accounting for about 80% of cases. This deformity is characterized by a Cobb angle greater than 10 degrees when measured on an anterior-posterior radiograph. Its prevalence among patients aged 10 to 18 years ranges from 2% to 4%.

Scoliosis management entails observation for small curvature (10 - 25 degrees), bracing for moderate curvature and surgical stabilization for curvature greater than 45 degrees. Although the incidence of surgical management is small, it is associated with substantial acute postoperative pain and notable psychological distress, including anxiety and depressive symptoms, for a significant subset of patients. Prospective trajectory studies show that many adolescents report moderate to severe pain in the immediate postoperative period that gradually declines over weeks, yet a non-trivial minority experience persistent postsurgical pain and pain-related interference. Anxiety and depression are more prevalent in AIS than in the general adolescent population and are linked with longer hospital length of stay after posterior spinal fusion. Qualitative work also indicates that concerns about body image, treatment efficacy, and loss of control around the time of surgery contribute to heightened anxiety in adolescents with AIS.

Preoperative pain and anxiety are strong predictors of both acute and longer-term postoperative pain in AIS, forming a continuum from pre- to postsurgical experiences. Higher baseline pain, anxiety, and pain catastrophizing are associated with more intense early postoperative pain, greater risk of persistent postsurgical pain at 6-12 months, and poorer health-related quality of life. Sex differences appear relevant: girls constitute the majority of AIS cases and tend to exhibit higher emotional distress and more tightly interconnected anxiety-depression symptom networks than boys. After posterior spinal fusion, female adolescents report higher average pain scores in the first 48 hours and at initial physical therapy compared with males, despite similar surgical characteristics and analgesic regimens, suggesting that female patients may require more proactive perioperative pain and psychological support.

Early postoperative mobilization, embedded within multimodal "rapid recovery" pathways, plays an important role in modulating pain, anxiety, and overall recovery after AIS surgery. Protocols that promote sitting, standing, and assisted ambulation within the first 24 hours, combined with scheduled non-opioid and rescue opioid analgesia, have been associated with reduced daily pain scores, fewer opioid-related side effects, earlier functional recovery, and shorter length of stay, without worsening pain or increasing readmissions. Given that opioids are commonly associated with adverse effects such as nausea, constipation, pruritus, drowsiness, and, less frequently, respiratory depression, multimodal and opioid-sparing regimens in AIS aim to reduce both pain intensity and opioid-related morbidity to facilitate earlier mobilization and recovery. By helping adolescents safely resume movement, early mobilization can lessen fear of movement and perceived fragility and may indirectly reduce anxiety and depressive symptoms that otherwise prolong hospitalization. Clinical pathways now explicitly list early mobilization as a key objective to standardize care, minimize opioid exposure, and support both physical and psychological recovery after AIS fusion.

Considering the familiarity that adolescents have with immersive gaming, VR-based interventions may help adolescents with AIS better tolerate early postoperative mobilisation by concurrently targeting pain and anxiety. Guided-relaxation and distraction-based VR sessions have shown transient reductions in postoperative pain intensity, pain unpleasantness, and anxiety in children and adolescents, with the greatest benefit in those with higher anxiety sensitivity. Systematic reviews and meta-analyses in pediatric populations indicate that VR distraction during medical procedures produces moderate-to-large reductions in pain and anxiety, supporting its use as a non-pharmacological tool alongside multimodal analgesia. Emerging perioperative trials suggest that integrating VR into early mobilization or physiotherapy can facilitate engagement, preserve or improve respiratory and functional parameters, and address fear of movement (kinesiophobia), which are all relevant to optimizing early post-fusion recovery in AIS.

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
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Adolescents aged 10 to 17 years hospitalized for corrective scoliosis surgery
  • Stable medical condition
  • Able to communicate in both French and English.

排除标准

  • Documented photosensitive epilepsy
  • Severe cognitive deficits, preventing assent
  • Prone to motion sickness.
  • The investigators will also recruit a sample of (HCP):
  • Closely implicated in the care of participants.

结局指标

主要结局

Recruitment Rate

时间窗: Through study completion, around one week.

Recruitment feasibility using a participant recruitment log. All eligible children will be approached for the study. The target is that at least 50% of participants agree to participate.

Completion Rate

时间窗: Through study completion, around one week

Protocol feasibility assessed using case report form (CRF) documentation. The procedure will be considered feasible if 90% of participants successfully complete the study procedures and assessments.

Acceptability of IVR among patients and HCP

时间窗: Post-intervention (immediately after returning to bed following mobilization)

This will be assessed using the Treatment Acceptability \& Preference (TAP), a 5- point Likert scale (0="not at all" and 4= "very much"), by both HCP and children and through interview feedback (qualitative).

Satisfaction regarding VR intervention

时间窗: This will be measured post-intervention (immediately after returning to bed following mobilization), and 14 days post-operative.

Children's and HCPs' satisfaction levels will be assessed using a 0-10 Verbal Numerical Rating Scale (VNRS), with 0 = low and 10 = high.

次要结局

  • Child Pain(This will be assessed at baseline (T0), after mobilization, before starting VR game (T1), before repositioning to bed (T2), & post-intervention (immediately after returning to bed following mobilization, T3), on day 1.)
  • Children's anxiety(This will be assessed at baseline (T0), after mobilization, before starting VR game (T1), before repositioning to bed (T2), and post-intervention (immediately after returning to bed following mobilization, T3), on day 1.)
  • Time tolerated in the armchair (minutes)(This will be assessed before repositioning to bed (T2), on day 1.)
  • Administration of narcotic analgesics(This will be assessed at baseline (T0), after mobilization, before starting VR game (T1), before repositioning to bed (T2), post-intervention (immediately after returning to bed following mobilization, T3) and in the subsequent 2 hours, on day 1.)
  • Side effects(This will be assessed at baseline (T0), after mobilization, before starting VR game (T1), before repositioning to bed (T2), & post-intervention (immediately after returning to bed following mobilization, T3), on day 1.)

研究者

发起方
St. Justine's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvie Le May

Principal Investigator

St. Justine's Hospital

研究点 (1)

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