Nurse Suicide: Physiologic Sleep Health Promotion Trial

NCT06079853 | Completed Results DMC

• 1 other identifier: AAAU3204
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify factors (sleep, psychiatric characteristics, stressful life events, and work environment characteristics) that potentiate or mitigate adverse effects of real-world stressors that predispose nurses to suicidal risk. The specific aims are: Aim 1. To investigate associations between sleep, stressful life events (life stressors, discrimination, lateral violence), psychiatric characteristics (psychiatric diagnosis, subjective mood), work environment characteristics (workload, shift type and duration, overtime, nurse work environment, and team relations) and stress (self-report and heart rate variability) in working nursing professionals while controlling for standard covariates known to influence stress. Aim 2. To determine if stress exposure (self-report and HRV) is associated with predisposing factors (sleep, stressful life events, additional psychiatric characteristics, and work environment characteristics), and to explore whether stress mediates the effect of predisposing factors on suicidal ideation in working nursing professionals. Exploratory Aim. To explore the preliminary impact of an existing sleep intervention (sleep health promotion kit) on self-reported stress, HRV, sleep, and psychiatric health outcomes including depression, burnout, and suicidal ideation. This record will focus on the Exploratory Aim.

Conditions

Suicide; Nurse's Role; Work Environment Adverse Effects; Sleep; Stress; Mental Health Wellness 1

Keywords

Suicide; Nurse; Sleep; Mental Health; Work Environment; Stress; Depression; Anxiety

Outcome Measures

Primary Outcomes (9)

• Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation

  This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Baseline (Week 1). CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.

  Baseline: Week 1

• Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation

  This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Follow-up (Week 4). CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.

  Follow-up: Week 4

• Columbia Suicide Severity Rating Scale (Intensity of Ideation) - Number of Participants With a Positive CSSRS Ideation

  This outcome measures the number of participants who had a score greater than 0 on the CSSRS at Follow-up (Week 8). CSSRS total score range is from 0-6, with the higher number indicating more intense ideation. Any score above 0 indicates a positive ideation in the past month.

  Follow-up: Week 8

• Physiologic Stress Response- Heart Rate Variability [Group Mean Difference Between Week 1-4(Control) and Week 5-8(Intervention)]

  Participants will wear the OuraRing to capture physiologic continuous heart rate variability. Heart rate variability is the variance in time between heart beats (RR intervals on an EKG) and is calculated using root mean square of successive differences between heartbeats. The middle 50% of 20-25 year olds usually have an average HRV in the 55-105 range, while 60-65 year olds tend to be between 25-45. In general, a higher heart rate variability is considered better as it indicates a more adaptable and resilient autonomic nervous system, which can respond effectively to different stressors. We calculated the mean difference between the control time period (Week1-4) and the intervention time period (Week 5-8).

  8 weeks

• Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)

  Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.

  baseline-Week 1

• Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)

  Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.

  Follow up- Week 4

• Perceived Sleep Quality Via Pittsburgh Sleep Quality Index Global Sleep Score (Group Mean)

  Scaling: Self reported Survey Instrument Range: 0 to 21 Interpretation: A global sleep score over 5 indicates poor sleep quality.

  Follow up- Week 8

• Physiologic Sleep Data - Sleep Duration (Mean Daily Hours)

  This is to measure the average amount of daily sleep (hours) over an 8 week period. The physiologic data is collected via a wearable device (OuraRing). We calculated the mean difference in sleep duration (hours) between Week 1-4 (Control time period) and Week 5-8(Intervention time period).

  8 weeks

• Number of Participants With at Least 1 Suicidal Behavior (Frequency)

  Total number of participants with at least 1 suicidal behavior that occurred during the given time period of 8 weeks.

  8 Weeks

Secondary Outcomes (6)

• Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score

  Baseline- Week 1

• Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score

  Baseline- Week 1

• Burnout Screening Via Maslach Burnout Inventory (Subscale 3: Personal Accomplishment) - Mean Composite Score

  Baseline- Week 1

• Burnout Screening Via Maslach Burnout Inventory (Subscale 1: Emotional Exhaustion) - Mean Composite Score

  Week 8

• Burnout Screening Via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score

  Week 8

Study Arms (1)

Experimental

EXPERIMENTAL

Single arm pilot sample will receive intervention

Behavioral: PureSomni Sleep Health Product Kit

Interventions

PureSomni Sleep Health Product Kit BEHAVIORAL

PureSomni sleep health products offered: blue light blocking glasses, eye mask, nasal strips, white noise machine, lavender spray, herbal tea, ear plugs

Experimental

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• currently practicing as a registered nurse in the clinical setting
• have worked continuously in the same position for at least 1 year
• read, speak, and understand English language

You may not qualify if:

• \>1-month sick leave in the past 3 months
• pregnancy (known physiologic stress confounder)
• other healthcare workers (e.g., physicians).

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

NewYork Presbyterian Hudson Valley Hospital

Cortlandt Manor, New York, 10567, United States

Location

MeSH Terms

Conditions

Suicide; Occupational Stress; Psychological Well-Being; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Occupational Diseases; Stress, Psychological; Personal Satisfaction; Mental Disorders

Limitations and Caveats

Sample Size is limited to pilot trial with 25 participants.

Results Point of Contact

• Title: Allison A. Norful
• Organization: Columbia University School of Nursing

aan2139@cumc.columbia.edu

2123057157

Study Officials

• Allison A Norful, PhD

  Columbia University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 12, 2023
• Study Start: September 8, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)