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临床试验/NCT05722249
NCT05722249已完成不适用

Interventions to Promote Well-being of Nightshift Nursing Team Members

Children's National Research Institute2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2022年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
87
试验地点
2
主要终点
Professional Quality of Life Scale, (ProQOL-21). The primary outcome variable will be change in professional quality of life as measured by the Professional Quality of Life Scale, (ProQOL-21).

研究概览

简要总结

Background:

Nightshift health care employees can experience greater likelihood of health threats such as weight gain, hypertension, and sleep disturbances. Evidence indicates a willingness of nightshift health care professionals to engage in wellness activities initiated at the work setting and during the assigned nightshift. In this single site study at a freestanding pediatric tertiary care hospital, inpatient units will be randomized to one of two nightshift interventions during an 8-week study period (mindfulness plus sleep hygiene or physical activity plus sleep hygiene). Immediately following the first study period, the randomized units will begin a second study period in which they will continue with the intervention first received but shall add the intervention not initially received. While there are hundreds of studies that describe the adverse health and safety effects of night shift work, there are few studies where interventions are tested for their efficacy to reduce the harm to workers or improve their well-being. Currently the few intervention studies that exist focus on the scheduling, duration and timing of work shifts, the timing of meals, and aspects of lighting in the workplace. Other interventions, such as those proposed in this study, have not been tested systematically using a rigorous design.

Purpose and Methods:

The purpose of this study, using a cluster cross-over randomized trial design, is to measure the impact on professional quality of life (primary endpoint) and medication administration error, role-related meaning, and sleep quality (secondary endpoints) of either a mindfulness intervention plus sleep hygiene (Arm A) or a physical activity intervention plus sleep hygiene (Arm B) in the first study period, and the combination of both interventions on the same outcomes in the second study period for nightshift health care employees.

详细描述

Study Purpose The purpose of this study, using a cluster cross-over randomized trial design involving inpatient units at a freestanding pediatric hospital, is to measure the impact on professional quality of life (primary endpoint), medication administration error, role-related meaning, and sleep quality (secondary endpoints) of either a mindfulness intervention (Arm A) or a physical activity intervention (Arm B) in the first study period, and the combination of both interventions on the same outcomes in the second study period for nightshift health care employees.

Primary Objective

1.The primary objective of this study is to determine and compare the impact on professional quality of life (as measured by the ProQOL scale) of either a mindfulness intervention (Arm A) or a physical activity intervention (Arm B) during an 8-week study period (study period 1).

1h1: ProQOL scale mean scores for compassion satisfaction will increase in both study arms during study period 1 from baseline (the week prior to randomization to the study Arms) to the end of the 8-week study period (Week 8).

1h2: ProQOL scale mean scores for compassion fatigue will decrease in both study arms during study period 1 from baseline (the week prior to randomization to the study Arms) to the end of the 8-week study period (Week 8).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

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

  • Eligible participants will be nurses and members of the nursing care team that work the nightshift fulltime or that rotate from the dayshift to the nightshift on a routine basis. Participants will need to be scheduled to work at least 2 weeks of the nightshift during each study period (Study Period 1, Study Period 2) to be fully eligible to participate in the study. To be fully eligible, participants must be able to complete a consent process and understand the study design and the self-report periods.

排除标准

  • Exclusion criteria would include nurses and nursing care team members who do not rotate regularly to the nightshift or who work only the dayshift.

结局指标

主要结局

Professional Quality of Life Scale, (ProQOL-21). The primary outcome variable will be change in professional quality of life as measured by the Professional Quality of Life Scale, (ProQOL-21).

时间窗: baseline or the week before randomization, Week 8 and Week 16

The ProQOL contains two domains: Compassion Satisfaction and Compassion Fatigue. For this study, we shall administer the ProQOL-21, a revised version of the ProQOL derived from a Rasch analysis (Heritage, et al., 2018) where higher scores mean better professional quality of life.

次要结局

  • change in Role-Related Meaning(Baseline or the week before randomization, Week 8 and Week 16)

研究者

发起方
Children's National Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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