Clinical Trials Directory

Trials / Completed

CompletedNCT03225885

Counseling for Prematurity Using a Multimedia Education Tool

Effectiveness of Prenatal Counseling for Prematurity Using a Supplementary Multimedia Parent Education Tool

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
76 (actual)
Sponsor
Medical College of Wisconsin · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This study evaluates the effectiveness of prenatal counseling when verbal counseling is supplemented with a multi-media mobile application versus a written gestational age handout.

Detailed description

Approximately 500,000 infants are born prematurely in the United States every year. Premature birth prior to 27 weeks gestation currently accounts for approximately 40% of infant mortality within the United States. When compared to full term infants, premature infants have a higher risk of physical or cognitive impairment and prematurity care accounts for over 26 billion dollars annually. Parents of premature infants are placed under significant emotional, financial, and personal stress. However, parental education about prematurity is often not evidenced based, varies significantly between OB and Neonatology providers, and lacks educational aids to help parents comprehend the information provided. Several medical societies (American Academy of Pediatrics (AAP), American Congress of Obstetrics and Gynecology (ACOG), National Institute of Child Health and Human Development (NICHD)) and parental advocates have voiced concern that the current practice is sub-optimal. Several studies have looked at this challenging situation from the family's perspective and have shown that parents find this counseling to be helpful but rarely reassuring and often stressful. Cognitive science research has recommended the use of multimedia information to simultaneously use both text and visual cognitive channels to improve information uptake and retention. Policy statements from the AAP, ACOG, and NICHD have all emphasized the importance of improving the prenatal counseling process to give our parents the most information possible so that they can make the best choices possible for their vulnerable infant. Potential study participants will be identified after hospitalization at Froedtert Hospital for premature labor. As per current clinical practice all mothers and their support person will have a neonatology consult requested by the obstetrician. These potential participants will be screened for eligibility in the study. Mothers and their support person will then be consented for participation and will be randomized to receive either verbal counseling with printed gestational age handout or verbal counseling with the multimedia information regarding prematurity. Participation of the pregnant woman's support person will be allowed by not required. If both mother and support person consent to participate, the support person will be will be assigned the same group as the mother. Participants will take a baseline STAI (State-Trait Anxiety Inventory) at time of randomization. After prenatal counseling has been completed by a neonatal provider (neonatology attending or fellow) the participants will be provided the validated questionnaire (previously developed) to assess their knowledge of prematurity based on the AAP recommended information for parents anticipating a premature birth. Participants will also retake the STAI.

Conditions

Interventions

TypeNameDescription
OTHERMultimedia InformationIs a multi-media mobile application that addresses information about prematurity, resuscitation, and NICU hospitalization.
OTHERPrinted HandoutPrinted Handout is a gestational age specific handout that addresses resuscitation and prematurity information.

Timeline

Start date
2017-12-01
Primary completion
2019-01-25
Completion
2019-01-25
First posted
2017-07-21
Last updated
2019-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03225885. Inclusion in this directory is not an endorsement.