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临床试验/CTRI/2026/01/101313
CTRI/2026/01/101313尚未招募不适用

Validation of pediatric scale for quality of recovery (PedSQoR) in Hindi for pediatric orthopedic surgical patients

Government Medical College and Hospital Chandigarh1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2026年1月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110
试验地点
1

研究概览

简要总结

This study aims to validate the Pediatric Quality of Recovery Scale (PedSQoR) in Hindi for children undergoing orthopedic surgery. PedSQoR is a questionnaire designed to measure recovery after surgery, including physical and mental well-being. The PedSQoR will be translated according to the established cross-cultural adaptation guidelines which include backward translation, forward translation, expert committee review, pilot testing and psychometric validation of the PedSQoR in Hindi. The study will include 110 pediatric patients aged 2–17 years. Children aged 7 years or older will complete the questionnaire themselves, while caregivers will complete it for younger children. Alongside the PedSQoR, Global Health Numerical Rating Scale (NRS) and the Visual Analogue Scale (VAS) for pain will be assessed to assess convergent validity of the Hindi PedSQoR. Assessments will be done at multiple postoperative time points to evaluate the reliability, validity, feasibility, and acceptability of the Hindi version. This study will provide a culturally appropriate tool to assess postoperative recovery and improve perioperative care for Hindi-speaking pediatric patients. This will make the PedSQoR easily comprehensible and acceptable to children and their families who speak Hindi, guaranteeing that the information gathered accurately represents their experience of recovery. Participation involves only completing the questionnaire, with no interventions or additional procedures.

AIM

To validate the pediatric scale for quality of recovery (PedSQoR) in Hindi for pediatric orthopedic surgical patients.

OBJECTIVES Primary ObjectiveTo assess the psychometric properties (validity, reliability) of the Hindi-translated PedSQoR in pediatric patients undergoing orthopedic surgery at 72h post-operative.

Secondary Objectives

1.   To assess the psychometric properties (validity, reliability) of the Hindi-translated PedSQoR in pediatric patients undergoing orthopedic surgery at 24h, 48h, 96h and the first post-operative OPD visit.

2.   To evaluate the acceptability and feasibility of the Hindi PedSQoR, including completion rates, time to complete, and ease of understanding.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • 1.Pediatric patients aged 2–17 years with American Society of Anaesthesiologists physical status (ASA-PS) I–III.
  • 2.Undergoing elective orthopedic surgery under general anaesthesia.
  • 3.Children aged more than/equal to 7 years, able to provide assent and comprehend, will complete the PedSQoR as self-report.
  • For children less than 7 years or those unable to self-report reliably, the primary caregiver will complete the scale as a proxy.

排除标准

  • 1.Parent or patient refusal to provide informed consent or assent 2.Obvious cognitive or sensory impairments or developmental delay in neurodevelopmental milestones.
  • 3.Presence of systemic diseases 4.Emergency surgery or surgery under regional anaesthesia 5.Parents, guardians, or patients who the investigator believes may not be available to complete the study.

研究者

发起方
Government Medical College and Hospital Chandigarh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Vinish Jain

Government Medical College and Hospital, Chandigarh

研究点 (1)

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