Clinical Trials Directory

Trials / Completed

CompletedNCT06921915

Efficacy of Animated Videos to Foster Healthy Bladder Behaviors in Community Women

Viewing Woman-Centered, Animated, Explainer Videos From the Confident Bladder Website to Optimize Bladder Health and Toileting Management Behaviors: A Randomized Controlled Trial in Community-Based Women at Midlife

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Kathleen O'Connell · Academic / Other
Sex
Female
Age
40 Years – 64 Years
Healthy volunteers
Accepted

Summary

In daily life, women are exposed to a wide range of challenging situations that can negatively affect toileting management and long-term bladder health. Research shows that women engage in behaviors that may lead to unfavorable consequences, such as a worrying sense of bladder urgency or an awkward moment of urine leakage. The investigators surmise that consciously or unconsciously adopted behaviors influence lifelong bladder health, toileting management, and sense of self-efficacy in this arena. Adoption of research-supported behaviors that foster bladder well-being for women is dependent on women's access to learning multiple healthy behavioral strategies. Studies on personal woman-centered strategies for toileting management and adoption of behaviors that foster bladder health are scarce in the scientific literature. The investigators have published encouraging results of an in-person study with a clinical sample using accessible and enjoyable videos about research-based bladder health behaviors, invented by the co-investigator of this study, Janis M. Miller. We now launch an additional study of 90 community-based women of midlife age using an online survey methodology that incorporates sending study participants to the website. The study has two main objectives: 1. To determine baseline bladder health and toileting management behavior profiles in intervention-naïve community-based women as assessed by the Confident Bladder Behavior Questionnaire 2. To determine at post-intervention whether behavioral profiles of the respondents have significantly changed after being randomized into one of three groups: Group 1: who watch the animated explainer videos within the Confident Bladder website that are predominantly related to daytime conditions, Group 2: who watch the Confident Bladder website's animated explainer videos predominantly related to sleep/wake conditions and the additional tips and tricks section, and Group 3: controls who only receive access to the the Confident Bladder website at study's end after post-intervention assessments. We will test the following hypothesis: Viewing the Confident Bladder website will demonstrate an effect size at 2-weeks post intervention of greater than 0.5, as determined by comparing number and percentage of research-based behavioral strategies used by the Control group to the number and percentage of strategies used by the two intervention groups who were assigned to view different parts of the website.

Conditions

Interventions

TypeNameDescription
OTHEReLearningParticipants in the intervention arms view a website developed by urinary bladder experts that presents information about how to prevent inconvenient urinary urges.

Timeline

Start date
2024-08-27
Primary completion
2024-09-09
Completion
2024-10-06
First posted
2025-04-10
Last updated
2025-04-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06921915. Inclusion in this directory is not an endorsement.