跳至主要内容
临床试验/CTRI/2026/04/109098
CTRI/2026/04/109098尚未招募不适用

To develop and validate composite comfort-pain-satisfaction scale(CCPS)

Dayanand medical college and hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年5月4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
120
试验地点
1

研究概览

简要总结

Post operative assessment is a complex and multidimensional process involving physical, psychological and emotional components. Traditionally, postoperative assessment has emphasized pain intensity as the primary marker of recovery and quality of care. However pain does not fully capture the patients overall well being or satisfaction with the surgical and anesthetic experience. in recent years , the concept of patient-centered care has gained prominence in perioperative medicine, with increasing recognition of need for comprehensive assessment tools that integrate multiple facets of patients postoperative experience, including comfort and satisfaction. A prospective,observational, single-centre study will be performed intended to develop and validate a novel patient -reported outcome measure(PROM) , the CCPS scale.the duration of the study will be approximately 12 months, accounting the time required for preparatory work, pilot testing, recruitment of participants, serial data collection a predefined time intervals , interim analysis and final statistical evaluation. the timeline may be adjusted depending on the rate of recruitment and logistical consideration. approximately 120 sample size will be taken. the ccps scale will be used at 60min, 3hrs, 6hrs and 24hrs post extubation , and will be used in ASA1-3 patients, surgical procedure done under general anaesthesia between ages of 18-65.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Adult patients aged 18 and above.
  • 2.Scheduled for elective surgery under general anaesthesia.
  • 3.Fully conscious, alert and oriented within one hour post extubation.
  • 4.Able to comprehend simple instructions and provide self-assessed ratings.
  • Willing and able to provide written informed consent after explanation.

排除标准

  • 1.Emergency surgical procedures.
  • 2.Post operative mechanical ventilation.
  • 3.History of cognitive impairment, major psychiatric illness, or neurological deficits affecting comprehension.
  • 4.Presence of significant language barriers or communication difficulties.
  • 5.Documented hearing impairment.
  • 6.Declines participation or withdraws consent at any point.

研究者

发起方
Dayanand medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shikha Gupta

Dayanand Medical College and Hospital

研究点 (1)

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