Postpartum Education Via Artificial Intelligence for Recovery and Loneliness: A Randomized Controlled Trial

NCT07223736 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-11-03

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether a postpartum chatbot powered by generative artificial intelligence (genAI) can help new mothers get better pelvic floor health information and feel less lonely after childbirth.

The main questions this study aims to answer are:

* Does using the chatbot improve postpartum pelvic floor health knowledge?
* Does using the chatbot help reduce feelings of loneliness during the postpartum period?
* Does using the chatbot impact pelvic floor symptoms?

Researchers will compare standard postpartum care to standard care plus the chatbot.

Participants will:

Be assigned by chance (like flipping a coin) to standard postpartum care with or without access to the chatbot.

If in the chatbot group, participants will receive education and support via the chatbot over a 4-week period.

Both groups will complete questionnaires to measure their pelvic floor knowledge, pelvic floor symptoms, feelings of loneliness, depression, infant bonding, perceived social support, adverse childhood experiences, and peri-traumatic distress.

The chatbot was created by urogynecology experts in collaboration with UC San Diego computer science and biomedical informatics researchers. The chatbot is designed to give new mothers personalized, evidence-based information and support in real time.

Conditions

  • Pelvic Floor Disorder
  • Loneliness
  • Postpartum
  • Mental Health
  • Depression
  • Peritraumatic Distress
  • Women
  • Artificial Intelligence (AI)
  • Chatbot

Interventions

OTHER

Generative artificial intelligence (genAI) postpartum chatbot

Participants randomly assigned to the chatbot intervention will be provided a URL to a secure, HIPAA-compliant web application hosted by UC San Diego (https://knolohealth.org/). This application features a generative AI-powered chatbot designed to deliver postpartum pelvic floor education and support. The chatbot is available for a 4-week period following enrollment and can be accessed at any time during that window. The chatbot's educational content is grounded in reputable, evidence-based resources, including national and international urogynecology patient education materials, as well as postpartum recovery guidelines. Participants can interact with the chatbot to ask questions and will receive tailored educational responses related to pelvic floor health. No additional in-person study visits are required for the intervention. Chatbot usage data (e.g., frequency, timing and content of chatbot interactions) will be collected to assess engagement and user needs.

OTHER

Standard of Care (SOC)

Access to the same postpartum care that participants would receive if they did not participate in the study.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-10
Primary Completion
2026-10-01
Completion
2026-11-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07223736 on ClinicalTrials.gov