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PureSomni Sleep Kit for Nurse Mental Health and Wellness
N/A
Recruiting
Led By Allison A Norful, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial seeks to identify factors that lead to suicidal risk in nurses. It will explore how sleep, psychiatric characteristics, stressful life events and work environment affect risk and if an existing sleep intervention can reduce it.
Who is the study for?
This trial is for English-speaking registered nurses who have been in the same clinical position for at least a year. It's not open to those who've had over a month of sick leave recently, other healthcare workers like doctors, or pregnant individuals.Check my eligibility
What is being tested?
The study is looking into how sleep and work stress affect nurses' mental health and risk of suicide. Nurses will use the PureSomni Sleep Health Product Kit to see if it helps reduce stress and improve sleep, mood, and overall psychiatric health.See study design
What are the potential side effects?
Since this trial involves non-medical interventions focusing on sleep improvement, significant side effects are not anticipated. However, changes in sleep patterns could potentially cause temporary discomfort or adjustment issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Columbia Suicide Severity Rating Scale (Intensity of Ideation) Mean Score - 8 weeks
Columbia Suicide Severity Rating Scale (Intensity of Ideation) Mean Score- 4 weeks
Columbia Suicide Severity Rating Scale (Intensity of Ideation) Mean Score- Baseline
+4 moreSecondary outcome measures
Burnout Screening via Maslach Burnout Inventory (Subscale 1: Burnout) - Mean Composite Score
Burnout Screening via Maslach Burnout Inventory (Subscale 2: Depersonalization) - Mean Composite Score
Burnout Screening via Maslach Burnout Inventory (Subscale 3: Personal Achievement) - Mean Composite Score
Trial Design
1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Single arm pilot sample will receive intervention
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,234 Total Patients Enrolled
9 Trials studying Sleep
434 Patients Enrolled for Sleep
Allison A Norful, PhDPrincipal InvestigatorColumbia University School of Nursing
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants currently being recruited for this research?
"This medical study, which was initially advertised on September 8th 2023, is currently seeking participants. The trial's details were last updated the following month."
Answered by AI
What is the current recruitment quota of participants for this clinical trial?
"Affirmative. According to clinicaltrials.gov, this scientific study is still seeking participants after being initially posted on September 8th 2023 and updated more recently on October 8th 2023. 25 individuals must be enrolled from one medical centre."
Answered by AI
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