Interventions to Promote Well-being of Nightshift Nursing Team Members

NCT05722249 | Completed

• 1 other identifier: ChildrensNRI
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Professional Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  baseline or the week before randomization, Week 8 and Week 16

Secondary Outcomes (1)

• change in Role-Related Meaning

  Baseline or the week before randomization, Week 8 and Week 16

Other Outcomes (3)

• Change in the PROMIS Sleep Disturbance Measure

  Baseline or the week before randomization, Week 8 and Week 16

• Change in the PROMIS Sleep-Related Impairment Measure (SRI)

  Baseline or the week before randomization, Week 8 and Week 16

• Change in Medication Error Administration

  60 days before Baseline, Week 8 and Week 16

Study Arms (2)

Arm A, Study Period 1 (Mindfulness and Sleep Hygiene):

EXPERIMENTAL

Immediately after the sleep hygiene content, the overview of the mindfulness intervention will be offered. All enrolled participants in Arm A, Study Period 1, will attend a 15 minute in-person "Introduction to Mindfulness" session after randomization.

Behavioral: Mindfulness and Sleep Hygiene

Arm B, Study Period 1 (Physical Activity and Sleep Hygiene):

ACTIVE COMPARATOR

All enrolled participants in the inpatient units randomly assigned to Arm B during Study Period 1 will receive written guidelines about physical activity during the nightshift (please see Appendix V). These guidelines will instruct them to achieve the goal of up to 15 minutes of physical activity between midnight and 0500 each nightshift during the 8-week study period. Each enrolled participant will view a video with voice over of the study team physical therapist demonstrating the methods.

Behavioral: Phyical activity and Sleep Hygiene

Interventions

Mindfulness and Sleep Hygiene BEHAVIORAL

Participants will experience demonstrations and explanations regarding sleep hygiene, mindfulness alerts for at work and mindfulness rest for at home.

Arm A, Study Period 1 (Mindfulness and Sleep Hygiene):

Phyical activity and Sleep Hygiene BEHAVIORAL

All enrolled participants in the inpatient units randomly assigned to Arm B during Study Period 1 will receive written guidelines about physical activity during the nightshift (please see Appendix V). These guidelines will instruct them to achieve the goal of up to 15 minutes of physical activity between midnight and 0500 each nightshift during the 8-week study period. Each enrolled participant will view a video with voice over of the study team physical therapist demonstrating the methods

Arm B, Study Period 1 (Physical Activity and Sleep Hygiene):

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Pamela Hinds, PhD, RN

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The cluster randomized crossover design is selected for logistical and ethical reasons: first, we seek generalizable findings; second, randomizing individual members of the nightshift will inevitably contribute to cross-contamination of the intervention arms; having a control group will similarly be at risk of contamination from peers randomly assigned to intervention arms as nightshift workers are assigned to float to other units when staffing needs merit such assignments; and given the known potential health risks for some nightshift workers, not providing an intervention could be considered unethical. In the cluster cross-over design, the staff in the participating clinical inpatient units will each receive an intervention during each of two time periods.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 10, 2023
• Study Start: December 7, 2022
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: June 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The above will be made available immediately after the publication of study outcomes by the study team.
• Access Criteria: A written request to the study PI will initiate the process of sharing the above items.

Locations

US (1)