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临床试验/NCT05182710
NCT05182710Enrolling By Invitation不适用

Preparing for the Stress of Resuscitation: A Randomised Control Trial of Simulation-based Stress Inoculation Training for UK Medical Professionals

Royal Cornwall Hospitals Trust2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
40
试验地点
2
主要终点
Heart Rate Variability

研究概览

简要总结

This study is to assess for the effectiveness of a Simulation-Based Stress Inoculation Training (SIT) Programme for junior doctors and physicians associates. It was well known that clinical practice can be stressful, particularly resuscitation events. When practitioners are stressed, they become less clinically effective. However, this is little in the way of training on how to manage acute stress in the workplace.

Stress Inoculation Training is established in military and sports training but is yet to be researched fully in junior doctors or physicians associates. By integrating a SIT programme into regular simulation training, the study aims to assess whether it helps with managing stress and performing better resuscitation. This assessment will be via questionnaire, heart rate monitors and judgement of clinical performance.

The study will be open to junior doctors and physicians associates who are currently practicing at the Royal Cornwall Hospital Trust and will take place in the Simulation Suite over a 6 month period.

Results will be prepared for publication and circulated among participants

详细描述

This study is a randomised control trial design. The study aim is to obtain 40 participants of varied roles, all healthcare professionals at the NHS RCHT. Participants will be asked to sign up to a session run in regular working hours at the RCHT simulation suite. If participants wish to take part in the study, after being consented to the project, they will be randomised to either the intervention arm or control arm.

Best practice/control is as follows

  1. 30 minutes of teaching on management of a drowning patient (or similar topic, in order that both control and intervention perceive they have had teaching of the same length as the other group)
  2. 1-2 resuscitation simulation events (same scenario and tasks as in the intervention group)

The SIT programme/intervention will involve

  1. 30 minute educational phase of preparatory information to allow participants to conceptualise the types of stressors they are likely to face and the role of stress on performance
  2. 30 minutes of skills acquisition which will involve teaching participants techniques to reduce stress in simulated resuscitation events
  3. Inoculation through the application of acquired skills in 1-2 resuscitation scenarios

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not know which of the two interventions (training modules) is being assessed.

Those facilitating simulations will also be blinded. Those assessing over-all effectiveness of resuscitation will be blinded to which arm participants are in

入排标准

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

入选标准

  • Any medical professional (junior doctors or physicians associates) currently working part/full time at RCHT
  • A current licence to practice
  • Willing to consent to participate in the study

排除标准

  • Anyone taking a medication which modifies heart rate (eg betablockers)
  • Unwilling to consent to participate in the study

结局指标

主要结局

Heart Rate Variability

时间窗: 10 minutes during simulation scenario

Difference in heart rate variability during simulated resuscitation events (objective measure)

State-Trait Anxiety Inventory Difference

时间窗: STAI takes about 1 minute to complete and participants will be asked to complete it 5 minutes before and 5 minutes after simulation event

Difference in State-Trait Anxiety Inventory (STAI) scores before and after resuscitation events (subjective measure)

次要结局

  • Situational Awareness Capacity(Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario)
  • Effectiveness of Resuscitation(An independent assessor will review the videos of simulation events within 2 months of the simulation event. Each simulation should last around 10 minutes)
  • Motor Task Capacity(Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario)
  • Cognitive Capacity(Participants will be given 1 minute to complete this task during the simulation event, before being asked to move on and continue the scenario)

研究者

发起方
Royal Cornwall Hospitals Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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