CTRI/2026/01/101957尚未招募3 期
Short Term Effect of Play Therapy on Pain and Functional Status in Pediatrics Post Cardiac Surgery -A Randmized Controlled Trial
TMVs lokmanya Tilak college of hysiotherapy raghunath vihar sector 14 Kharghar Navi Mumbai 4102101 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年2月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
研究概览
简要总结
Methodology Randomized Controlled Trial (RCT). 70 pediatric patients (5-10 yrs) post-cardiac surgery were divided into two groups (n=35 each) via simple random sampling. Group A (Control): Conventional Physiotherapy. Group B (Experimental): Play Therapy + Conventional Physiotherapy.
Outcomes Measures Primary Outcomes: Pain (measured by Faces Pain Scale-Revised (FPS-R)) and Functional Status (measured by Functional Status Score (FSS)).
Procedure Baseline assessment (Pain/FSS) on Post-Operative Day 2 (POD-2). Interventions (one session/day) were administered for six consecutive days. Reassessment (Pain/FSS) was performed on Post-Operative Day 7 (POD-7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 5-10 years of age who are undergoing cardiac surgery.(congenital cardiac surgery ) Both male and female.
- •Written informed consent and assent from parent.
- •Ability to understand the language used in the assessment tools and instructions.
- •extubated patients ( POD-2).
排除标准
- •Presence of other chronic or acute conditions (e.g., primary neuromuscular disorders, orthopedic issues,) that may independently affect posture or physical function.
- •History of additional major surgeries unrelated to cardiac surgery within the past year.
- •patients with sternal wound infections, dehiscence, or major complications preventing participation.
- •children unable to engage in play therapy.
研究者
Dr Trupti Balasaheb Aher
TMVs Lokmanya Tilak college of physiotherapy Kharghar Navi Mumbai
研究点 (1)
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