CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
RCT Treatment -Listening Visits delivered by NICU nurse in person +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03704948
NCT03704948N/ACompleted

Promoting Emotional Well-Being in Distressed NICU (Neonatal Intensive Care Unit) Mothers: A Phase 2 Evaluation of a Nurse-Delivered Approach

University of Iowa·interventional·Posted Oct 15, 2018·Updated Sep 29, 2023

In Brief

A clinical study evaluating RCT Treatment -Listening Visits delivered by NICU nurse in person, RCT Control Usual mental health care delivered by NICU social workers, and 1 other intervention for Nurse Delivered Counseling and Emotional Distress. Completed, enrolled 55 participants across 1 site.

Detailed Summary

The proposed research has potential to dramatically improve care for emotionally distressed mothers of newborns hospitalized on the neonatal intensive care unit (NICU). Clinical NICU nurses are well-positioned to provide emotional support in the form of Listening Visits. Specifically, these nurses are easily accessible to NICU mothers, are often the most trusted professional on the healthcare team, they are knowledgeable about the newborn's medical conditions, and, finally they are already skilled in the art of warm communication. This intervention should not only improve depressive outcomes in emotionally distressed NICU mothers but also indirectly impact maternal perception of nurse support which is in turn related to depression symptoms and patient satisfaction, as well as infant length of stay by accelerating maternal readiness for infant discharge.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 15, 2018
Enrollment StartFeb 14, 2019
Primary CompletionJun 20, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.7 years ago

Interventions

RCT Treatment -Listening Visits delivered by NICU nurse in personbehavioral

6 sessions, approximately one hour in length, delivered by a nurse who uses empathic listening and problem solving.

RCT Control Usual mental health care delivered by NICU social workersbehavioral

RCT Control Usual mental health care delivered by NICU social workers

Open trial: Listening Visits delivered by a NICU nurse via zoombehavioral

Open trial: Listening Visits delivered by a NICU nurse via zoom