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临床试验/CTRI/2024/04/065530
CTRI/2024/04/065530尚未招募不适用

Evaluation of Pre-operative Anxiety & Its Relation to Post-operative Pain in Patients Undergoing Elective Brain Tumor Surgery. A Prospective Observational Study.

Mynu Arya1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月21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
100
试验地点
1
主要终点
Positive correlation between Pre-operative Anxiety and Post-operative Pain

研究概览

简要总结

  • The title of my study is "Evaluation of Pre-operative Anxiety and it’s relation to Post-operative Pain in patients undergoing elective brain tumor surgery. A Prospective Observational Study."
  • Inclusion Criteria -
  1. Patients of either sex
  2. 18-70 yrs of age
  3. Patients with ASA 1 to ASA 3 status
  4. Undergoing elective craniotomy under general anaesthesia
  5. Patients who will be extubated on table
  • Exclusion Criteria -
  1. Refusal to participate
  2. Unconscious Patient
  3. Patients with disabilities and cognitive impairment defined as a score less than or equal to 24 points in MMSE (Mini Mental Status Examination)
  4. Patient not able to collaborate on the Post-operative clinical assessment
  • All the eligible patients will be informed about the anaesthesia method and assessed for Pre-operative Anxiety one day prior to the surgery with the help of STAI (State Trait Anxiety Inventory) and APAIS (Amsterdam Pre-operative Anxiety information scale) questionnaire .
  • The patients will then be guided on how to perform Post-operative NRS to evaluate Post-operative Pain.
  • Patients will undergo elective brain tumor excision or decompression under general anaesthesia.
  • After the surgery, the patient will be evaluated according to NRS Score at 1 hour, 3 hour, 6 hour, 12 hour and 24 hour Post-operatively.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex
  • 18-70yrs of age
  • ASA Grade I-III
  • Undergoing elective craniotomy under general anaesthesia, who will be extubated on table.

排除标准

  • Patients who refuse to participate in study
  • Unconscious patients
  • Patients with disabilities and cognitive impairment defined as a score less than or equal to 24 points in Mini Mental Status Examination
  • Patients not able to collaborate on Post-operative clinical assessment.

结局指标

主要结局

Positive correlation between Pre-operative Anxiety and Post-operative Pain

时间窗: At 1 hour, 3 hour, 6 hour, 8 hour, 12 hour and 24 hour Post-operative period

次要结局

  • To compare APAIS score & STAI score with NRS at 1 hour, 3 hour, 6 hour, 8 hour, 12 hour & 24 hour Post-operative period(Consistent results in both APAIS score & STAI score at 1 hour , 3 hour, 6 hour, 8 hour, 12 hour & 24 hour Post-operative period)

研究者

发起方
Mynu Arya
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Mynu Arya

AIIMS Rishikesh

研究点 (1)

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