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临床试验/NCT03408002
NCT03408002已完成不适用

PREPARE: Valutazione di un Intervento Psicologico Pre-operatorio in Pazienti Che Saranno Sottoposti a Chirurgia Del Pancreas

Azienda Ospedaliera Universitaria Integrata Verona2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Change of Perceived self-efficacy, comparing the score on analogue scale (range 1-10) before (baseline) and after the psychological intervention in the experimental group.

研究概览

简要总结

The study aims to verify if a short individual psychological intervention might increase perceived self-efficacy in managing preoperative anxiety in patients who will undergo pancreatic surgery. It is a randomized clinical trial where half of participants will attend a psychological intervention based on "the four elements protocol" by Elan Shapiro the day before surgery, while the other half will follow usual care.

详细描述

Patients who have to undergo surgery experience multiple sources of stress. A recent narrative review carried out on 115 studies by Powell et al. (2016) reported different and inconsistent findings on the relation between psychological interventions and surgery outcomes, due to the heterogeneity of these interventions, mainly based on information giving and patient education, and the very different samples of patients considered. Some evidences showed that pre-operative psychological interventions may contribute to reduce post-operative pain, duration of hospital stay (mean difference of 0.52 days) and negative affect. No studies were conducted with patients who had to undergo pancreatic surgery nor specific psychological interventions were devoted to increase self-efficacy in managing anxiety.

The aim of the present study is to verify if a short individual psychological intervention devoted to improve patient's ability to manage anxiety could increase his/her confidence to cope with pancreatic surgery, either in terms of perceived self-efficacy (main outcome) or less state anxiety reported on STAI-Y1 scale. Post-surgery outcomes are also collected: pain reported during the days following surgical intervention, length of hospital stay and number and type of clinical complications.

The study will involve 400 patients randomly divided in two arms and it is organized in four phases: T0,T1,T2,T3.

T0: Once obtained the informed consent, demographic information will be collected using a structured questionnaire. Clinical variables will be collected by self-administered tools, for which patients can ask support, if needed.

T1: The day before surgery, all patients will indicate their perceived self-efficacy in managing anxiety and will fulfil specific anxiety scales.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 - 80 years old
  • cognitively able to give personal consent to participate to the study
  • to be scheduled to have general anaesthesia for pancreatic surgery

排除标准

  • age under 18 years and over 80 years
  • cognitively unable to give personal consent to participate to the study
  • postponement of surgical operation

研究组 & 干预措施

control group

No Intervention

no intervention

Psychological intervention

Experimental

Psychological intervention using the "Four elements" technique elaborated by Shapiro and reported in M. Luber (2009) during a psychological consultation conducted the day before surgery.

干预措施: Psychological intervention (Behavioral)

结局指标

主要结局

Change of Perceived self-efficacy, comparing the score on analogue scale (range 1-10) before (baseline) and after the psychological intervention in the experimental group.

时间窗: Perceived self-efficacy will be measured before (baseline) and immediately after the psychological intervention (up to 1 hour) in the experimental group, whereas in the control group it will be measured only once (baseline).

To measure perceived self-efficacy, patients respond to the following question: "We kindly ask you to indicate on a scale from 1 to 10 how much you perceive to be able to manage anxiety before the surgery".

次要结局

  • Number of perioperative complications(30 days)
  • Number of days of hospitalization(From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 6 months.)
  • VAS-P Visual Analogue Scale of Pain.(from the 3rd day until 5th day after surgery)
  • Post-operative pain measured by the Brief Pain Inventory(3rd day after surgery)

研究者

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

Lidia Del Piccolo

Professor

Azienda Ospedaliera Universitaria Integrata Verona

研究点 (2)

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