Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05722249 |
| Other study ID # |
ChildrensNRI |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 7, 2022 |
| Est. completion date |
January 30, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
Children's National Research Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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).
1h3: ProQOL scale mean scores for compassion satisfaction will not differ at baseline (the
week prior to randomization to the study Arms) or at the end of the first study period (Week
8) between the two study arms.
1. h4. ProQOL mean scores for compassion fatigue will not differ between the two arms at
baseline (the week prior to randomization to the study Arms) or at the end of the first
study period (Week 8).
Secondary Objectives 2. Determine and compare the impact on professional quality of life
(as measured by the ProQOL scale) of the combined mindfulness intervention and physical
activity intervention (Arms A and B) during a second 8-week study period (study period
2) as compared to the first study period.
2. h1: ProQOL scale mean scores for compassion satisfaction will increase in both study
arms during study period 2 from the end of the first 8-week study period (Week 8) to the
end of the second study period (Week 16), and from baseline to Week 16.
2h2: ProQOL scale mean scores for compassion fatigue will decrease in both study arms during
study period 2 from the end of the first 8-week study period (Week 8) to the end of the
second study period (Week 16), and from baseline to Week 16.
2h3: ProQOL scale mean scores for compassion fatigue will not differ between the two arms at
Week 8 or at the end of the second study period (Week 16).
2h4. ProQOL scale mean scores for compassion satisfaction will not differ between the two
arms at Week 8 or at the end of the second study period (Week 16).
3. Determine and compare the impact of the interventions by study period on role-related
meaning as measured by the Role-Related Meaning Scale (RRMS) and sleep quality as measured by
the PROMIS Sleep Disturbance measure and the PROMIS Sleep-Related Impairment Measure (SRI).
3h1: the RRMS mean scores will increase and PROMIS Sleep Disturbance and SRI mean scores will
decrease in both study arms from baseline to Week 8, from Week 8 to Week 16, and from
baseline to Week 16.
3h2: the RRMS mean scores and the PROMIS Sleep Disturbance and SRI mean scores will not
differ between the two arms at baseline, Week 8 or at Week 16.
4. Determine the impact of the intervention periods (Week 8, Week 16) on a patient-related
indicator, Medication Administration Error as compared to the error rate at baseline.
4h1: Medication Administration Errors will not differ between the two study arms at baseline,
Week 8 or at Week 16.
4h2: Medication Administration Errors will decrease within both study arms from baseline to
Week8, and from Week 8 to Week 16.
General Design Description The study design is a cluster cross-over randomized trial
involving 11 inpatient units at a freestanding pediatric hospital. In the randomization, the
11 units will be randomized to two study arms (Arm A - mindfulness intervention plus sleep
hygiene information; Arm B - physical activity plus sleep hygiene information) during the
first 8-week study period. Immediately following this study period, the units assigned to
each arm will cross and receive the intervention not received in the first study period plus
the ongoing access to the previous intervention. Both arms in the first study period will
have education content specific to sleep hygiene connected to the existing napping option.
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. Interventions, such as physical activity and
mindfulness, that can be done at the group level and may be more effective when done with a
group, are ideal for this design (Arnup et al., 2014; Arnup et al., 2017; Parienti & Kuss,
2007; Moerbeek, 2020; Reich et al., 2012). This design is also selected for its efficiency
and reduced costs compared with a clinical trial with individuals being randomized (Taljaard
et al, 2013).
