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N/A
Trial #1: (RCT) Treatment Group: Listening Visits delivered by NICU nurse in person for Emotional Distress
N/A
Waitlist Available
Led By Lisa S. Segre, PhD
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to speak and read English
Hospitalized newborn
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks and 8 weeks
Awards & highlights
Study Summary
This study is evaluating whether listening visits from nurses can help improve the emotional well-being of mothers of newborns in the neonatal intensive care unit.
Eligible Conditions
- Emotional Distress
- Nurse Delivered Counseling
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks and 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks and 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean IDAS-GD Score at 4 Weeks (End of Treatment) and 8 Weeks (Follow up)
Secondary outcome measures
Reliable Change Index
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Trial #2Open Trial: Listening Visits delivered by NICU nurse over zoomExperimental Treatment1 Intervention
Open Trial: Listening Visits delivered by NICU nurse over zoom
Group II: Trial #1: (RCT) Treatment Group: Listening Visits delivered by NICU nurse in personExperimental Treatment1 Intervention
Listening Visits delivered by a NICU nurse in person in the RCT
Group III: Trial #1: (RCT): Control Group -Mental health care delivered by NICU social workActive Control1 Intervention
Mental health care provided by NICU social workers.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RCT Treatment -Listening Visits delivered by NICU nurse in person
2019
N/A
~60
Open trial: Listening Visits delivered by a NICU nurse via zoom
2019
N/A
~60
Find a Location
Who is running the clinical trial?
University of IowaLead Sponsor
444 Previous Clinical Trials
878,655 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
576 Previous Clinical Trials
10,375,078 Total Patients Enrolled
Lisa SegreLead Sponsor
Frequently Asked Questions
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