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临床试验/NCT06015646
NCT06015646撤回不适用

Lifestyle Education and Personalized Coaching for Fatigue Mitigation in Emergency Medicine Residents: A Pilot Study

Stanford University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
30
试验地点
2
主要终点
Mean of the 3 overnight number of false starts in the psychomotor vigilance test

研究概览

简要总结

The purpose of this study is to determine whether personalized lifestyle coaching minimizes the negative impact of circadian disruption on performance and recovery in emergency medicine physician trainees during night shifts.

详细描述

The goal of this study is to examine whether a brief personalized fatigue-mitigation lifestyle coaching (PFMLC) for emergency medicine residents on overnight shifts would minimize the negative effects of circadian rhythm disruptions on performance and recovery compared to those who receive one-time passive information on lifestyle practices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

One of the two principal investigators and researchers who analyze the data will be blinded to the group assignment.

入排标准

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

入选标准

  • Stanford Health Care (SHC) Emergency Medicine residents (PGY 1 to 4)
  • Scheduled to work at least 3 consecutive overnight shifts at SHC Emergency Department.

排除标准

  • Non-Stanford Health Care (SHC) Emergency Medicine residents
  • Stanford Health Care (SHC) Emergency Medicine residents who are not rotating in Stanford Emergency Medicine Department

研究组 & 干预措施

Lifestyle Coaching and Educational Handout

Experimental

Lifestyle coach-led 30-minute focused, personalized session in addition to educational handout containing lifestyle tips for fatigue mitigation in night shift workers, which will be given to all participants at the beginning of the study.

干预措施: Personalized lifestyle coaching and educational handout (Behavioral)

Lifestyle Coaching and Educational Handout

Experimental

Lifestyle coach-led 30-minute focused, personalized session in addition to educational handout containing lifestyle tips for fatigue mitigation in night shift workers, which will be given to all participants at the beginning of the study.

干预措施: Handout (Behavioral)

Educational Handout Control

Active Comparator

An educational handout containing lifestyle tips for fatigue mitigation in night shift workers will be given to all participants at the beginning of the study. Personalized coaching will not be offered to participants in this arm.

干预措施: Handout (Behavioral)

结局指标

主要结局

Mean of the 3 overnight number of false starts in the psychomotor vigilance test

时间窗: 3 night shifts

The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. Investigators will compare the mean of the 3 overnight number of false starts (lower is desirable) in the PVT test between the control and intervention groups.

Mean of the 3 overnight Aggregate Scores of the psychomotor vigilance test

时间窗: 3 night shifts

The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. Investigators will compare the mean of the 3 overnight Aggregate Score (0 worst-100 best and derived from the number of lapses and false starts) of the PVT test between the control and intervention groups.

Mean of the 3 overnight reaction time reciprocal of the psychomotor vigilance test

时间窗: 3 night shifts

The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. Investigators will compare the mean of the 3 overnight Mean reaction time reciprocal (lower is desirable) of the PVT tests between the control and intervention groups.

Mean of the 3 overnight number of lapses in psychomotor vigilance test

时间窗: 3 night shifts

The primary outcome of this study is psychomotor vigilance assessed by the Psychomotor Vigilance Test (PVT) measured by the PVT WorkFit iPhone app by Joggle Research by Pulsar. This test takes approximately 3 minutes to complete. The PVT is a widely used objective measure of sustained attention and reaction time, which provides valuable insights into participants' alertness and cognitive performance during different times throughout each of at least 3 consecutive night shifts. Investigators will compare the mean of the 3 overnight number of lapses ( lower is desirable) of the PVT test between the control and intervention groups.

Mean of the 3 overnight Stanford Sleepiness Scale

时间窗: 3 night shifts

The Sleepiness Symptom Scale (SSS) is a validated subjective measure of sleepiness frequently used for research and clinical purposes. It evaluates sleepiness at specific moments in time using a single-item scale. Respondents select one of seven statements to indicate their level of perceived sleepiness. Score Range: The scale score ranges from 1 to 7, reflecting the varying degrees of sleepiness experienced by respondents. This test takes approximately 15 seconds to complete. Directionality: Higher scores on the SSS represent higher perceived sleepiness, while lower scores indicate increased alertness and desirable. Investigators will compare the mean of the 3 overnight SSS scores between the control and intervention groups

Mean of the 3 overnight Noordsy-Dahle Subjective Experience Scale (NDSE)

时间窗: 3 night shifts

Modified version of Noordsy-Dahle Subjective Experience Scale (NDSE) for healthy adults includes 8 sub-domains: Global well-being, Delighted 1 to Terrible 7, Lower score better Anxiety: None 1 to Extreme 7, Lower score better Depression: None 1 to Extreme 7, Lower score better Energy: Tired 1 to Energized 7, Higher score better Motivation: None 1 to Strong 7, Higher score better Clarity of thought: Clouded 1 to Totally Clear 7, Higher score better Concentration: Poor 1 to Excellent 7, Higher score better Social interest: Alone 1 to With Others 7, Higher score better This test takes approximately 90 seconds to complete. Investigators will compare the mean of the 3 overnight Noordsy-Dahle Subjective Experience Scale scores between the control and intervention groups.

次要结局

  • Mean of total sleep hours(3 weeks)
  • Mean of heartrate variability(3 weeks)

研究者

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

Maryam S Makowski, PhD

Clinical Assistant Professor

Stanford University

研究点 (2)

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