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临床试验/NCT04363281
NCT04363281已完成不适用

The Effect of Anxiety on Perioperative Pain: Patient and Provider Perception : A Prospective Observational Study

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2020年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
193
试验地点
1
主要终点
Verbal numeric Score of postoperative pain

研究概览

简要总结

In this study we will assess the incidence and severity of intraoperative and postoperative pain and determine the effect of preoperative anxiety on intraoperative and postoperative pain incidence. Secondary outcome is to assess provider perception of pain.

详细描述

This is a prospective, observational study. Following obtaining written formal consent parturients will be requested to fill out the following questionnaires

  1. Three questions to predict acute pain:
  • Verbal numeric score Anxiety 0-10
  • Anticipated postoperative pain level
  • Anticipated analgesic requirements
  1. Speilberger STATE-TRATE inventory index
  2. Pain Catastrophizing Scale In the post anesthesia care unit (PACU) parturients will be approached and requested to fill out a questionnaire regarding intraoperative pain, medication consumption, anxiety and nausea. Furthermore parturients will also be approached at 12 hours and 48 hours postpartum and questioned regarding anxiety levels and medication consumption and requested to fill out the OBSQOR 11 questionnaire at 12 hours postpartum.

Additionally, both the attending anesthesiologist and obstetrician will be questioned regarding the parturient's level of intraoperative pain, postoperative pain levels anxiety medication consumption, uteronic management, surgical technique and management.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • *Women undergoing an elective cesarean section under spinal anesthesia with the ability to comply with the study requirements will be eligible for participation

排除标准

  • All women unable to receive spinal anesthesia or with inadequate spinal anesthesia prior to the beginning of surgery (Less than T4 Sensory Level to pinprick assessed from blunt tip needle in caudal to cranial direction )
  • All women receiving antianxiety medication
  • Language barrier

结局指标

主要结局

Verbal numeric Score of postoperative pain

时间窗: 24 hours

measured by a verbal numeric score from 0-10

Preoperative Anxiety

时间窗: 2 hours before surgery

Score from 0-10

Verbal numeric Score of intraoperative pain

时间窗: 1 hour during surgery

measured by a verbal numeric score from 0-10

次要结局

  • Patient provider perception of pain(1 hour during surgey)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

sharonorbach

Professor Sharon Orbach-Zinger

Rabin Medical Center

研究点 (1)

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