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临床试验/CTRI/2024/10/075365
CTRI/2024/10/075365
进行中(未招募)
不适用

Sleep quality trajectories assessment of cancer patients during perioperative period: an observational study

Kalyan Singh Super Speciality Cancer Institute Lucknow India1 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2024年10月21日最近更新:

概览

阶段
不适用
状态
进行中(未招募)
发起方
Kalyan Singh Super Speciality Cancer Institute Lucknow India
入组人数
316
试验地点
1
主要终点
To study the sleep quality trajectories of onco-surgical patients during peri-operative period

概览

简要总结

Aim of the study is to assess sleep quality trajectories of cancer patients during peri-operative period and to track down risk factors which causes sleep disturbance. objectives are to study quality trajectories and identify and quantify the main conditioning factors of poor sleep. Study will start after getting ethical clearance, study duration will be 12 months. Sample size is 316. patients who come to PAC clinic will be screen for study. only those patients will be enrolled who will give consent and fullfill inclusion and exclusion criteria. Socio-demographic will be recorded. history of chemotherapy and radiotherapy and current medications will be noted. ASA physical status and ECOG score will be roecorded. then every enrolled patient, their sleep quality will be asked Richard Campbell Sleep Questionnare (RCSQ) as a baseline score during their PAC visit and in the morning of surgery and in postoperative period till day 3. there is minimal risl to patients. the potential outcomes will be that cancer patients during peri-operative period will be having distuebed sleep and their gravity and factors causing disturbed sleep.

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

  • consenting patients who will be posted for elective cancer surgeries and extubated in operation theatre and then shifted to post-anaesthesia care unit.
  • patients who are conscious and oriented and able to read and write.

排除标准

  • All Non-consenting onco-surgical patient, age less than 18years and more than 70years, who are on mechanical ventilation in postoperative period or require emergency surgery or develop post-operative complications like who require re-exploration, or mechanical ventilation, dyselectrolemia, and or unable to communicate verbally or through writing, Patients with intracranial lesion), Patients who will be previously diagnosed with any psychiatric disorder and Patients who will be previously diagnosed with sleep disorder.

结局指标

主要结局

To study the sleep quality trajectories of onco-surgical patients during peri-operative period

时间窗: at the time of PAC, in the morning of surgery, at post operative day 1, 2, 3

次要结局

  • 1.To identify and quantify the main conditioning factors of poor sleep.(i.Individual characteristics (age, gender, education, employment status, marital status, BMI, tobacco and alcohol intake history))

研究者

发起方
Kalyan Singh Super Speciality Cancer Institute Lucknow India
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Archana Gautam

Kalyan Singh Super Speciality Cancer Institute Lucknow

研究点 (1)

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