跳至主要内容
临床试验/CTRI/2025/03/081518
CTRI/2025/03/081518尚未招募不适用

PADon Study: Prevalence of Anxiety and Depression In Oncology Patients During Perioperative Period And Its Effect On Perioperative Pain–Prospective,observational single center study.

Department of Anesthesia , Critical Care and Pain1 个研究点 分布在 1 个国家目标入组 336 人开始时间: 2025年3月7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
336
试验地点
1
主要终点
The prevalence of anxiety will be reported as proportions with 95% confidence intervals.

研究概览

简要总结

Anxiety is defined as an unpleasant emotion when a person is in a tense and apprehensive state which arises when a person anticipates danger both internally and externally.

Perioperative anxiety, depression and perioperative pain are two common problems faced by patients undergoing surgery, which are associated with numerous suboptimal postoperative outcomes like delayed healing, increased hospital stay.

This study will investigate the Prevalence of Anxiety and Depression in Oncology Patients in the Perioperative Period. This study will include the patients of age more than 18 years undergoing elective surgery. One day before surgery we will assess the patient for their anxiety,depression and pain scores and shall obtain a written informed consent.Patients fulfilling the inclusion criteria will be assessed again at post operative 48 hours for their scores,and proper medical attention shall be given for the patients with high scores on the scale.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.99 Year(s)(—)
性别
All

入选标准

  • American society of Anesthesiologists (ASA) Grade I -III Patients undergoing oncological surgeries for:- Gynecological Procedures Orthopedic Procedures Gastrointestinal Procedures Urological Procedures Thoracic Procedures Head and Neck Procedures Requiring postoperative admission in the hospital ward for a minimum 48 hours.

排除标准

  • 1 Patients unwilling to participate in the study.
  • 2 Difficulty in communication because of language limitation or planned tracheostomy in the postoperative period.
  • 3 Patients already receiving psychoactive medications.
  • 4 Surgeries with expected cognitive impairment in the post-operative(Any pre-existing cognitive defects or Neurosurgeries).
  • 5 Patients previously diagnosed with major depressive disorder/other forms of depression and generalised anxiety disorder and may or may not be on treatment for the same.
  • 6 Patients undergoing surgery for recurrent or second cancer.
  • WITHDRAWAL CRITERIA: Patients needing ICU care for more than 48 hours,post operatively.

结局指标

主要结局

The prevalence of anxiety will be reported as proportions with 95% confidence intervals.

时间窗: One day before and 48 hours after surgery

次要结局

  • 1. To study the prevalence of depression and to assess the severity of Anxiety and Depression in the postoperative period(2. To study the association between anxiety and depression and the perioperative Pain scores following oncological surgery using Numerical Rating Scale (NRS).)

研究者

发起方
Department of Anesthesia , Critical Care and Pain
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sumitra Bakshi

Tata Memorial Hospital

研究点 (1)

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