Nurse Suicide: Physiologic Sleep Health Promotion Trial

NCT ID: NCT06079853

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-08
• Study Completion Date: 2024-09-01

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.

Detailed Description

Despite being the largest healthcare workforce in the United States (US) (~5 million nurses), evidence about suicidal ideation and predisposing factors that contribute to suicide in nurses is limited. Outside of nursing, there is substantial evidence that an individual's psychiatric characteristics (psychiatric diagnosis; decision-making; social cognition; mood) and/or life stressors (e.g., death of a loved one, divorce, discrimination, or lateral violence) are significantly associated to suicidal ideation. Yet, it is unclear why nurses have higher rates of suicide compared to other populations and which factors predispose nurses to higher risk for suicidal behavior. It has become critical to test new approaches to reduce stress in nurses and subsequently mitigate suicide ideation. There is early evidence that sleep disturbances may induce increased stress and subsequently higher psychological risk, including depression, a known predisposing risk factor for suicidal risk. Evidence about the associations between sleep and suicidal ideation is limited but early studies show promise that interventions promoting sleep health may help mitigate suicidal risk. The isolation of predisposing factors for stress in nurses and investigation of potential interventions to counteract such stress may help to identify and mitigate suicide risk in nurses. Past evidence about suicide has been limited to post-mortem data inhibiting an understanding of which personal, psychosocial, and work environment factors predispose a nurse to suicidal behaviors. The combined study of self-report and physiologic data may help us better understand sources of stress adaptation in the search for underlying biological mechanisms associated with suicide and other suboptimal psychologic health outcomes.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Experimental

Single arm pilot sample will receive intervention

Group Type: EXPERIMENTAL

PureSomni Sleep Health Product Kit

Intervention Type: BEHAVIORAL

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

Interventions

PureSomni Sleep Health Product Kit

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Allison Norful

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison A Norful, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University School of Nursing

Locations

NewYork Presbyterian Hudson Valley Hospital

Cortlandt Manor, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

AAAU3204

Identifier Type: -

Identifier Source: org_study_id