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NCT02119936 · ClinicalTrials.gov registry record · NA

Feasibility of Heart Rate Variability Biofeedback With In-patient Pregnant Women

A NA study, sponsored by University of North Carolina, Chapel Hill.

Terminated
Registry status
NA
Development phase
10
Enrollment target

NCT02119936: Clinical Trial NA study, sponsored by University of North Carolina, Chapel Hill.

NCT02119936 is a NA study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02119936, a NA study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.

TERMINATED
Registry status
NA
Development phase
10 participants
Enrollment target

Study Summary

Purpose: The investigators plan a feasibility study on an easily disseminated biofeedback tool to reduce stress among hospitalized and expecting mothers. Converging evident suggests that Heart Rate Variability Biofeedback (HRVB) can improve the threshold of stress management and improve executive functioning. Additionally HRVB has been shown to significantly reduce anxiety features in women suffering from perinatal depression. The investigators hypothesize that HRVB will reduce stress levels among expecting mothers hospitalized for pregnancy complications, who are at high risk for depression and anxiety. Participants: Expecting mothers hospitalized for pregnancy complication, who are at high risk for depression and anxiety. Procedures: The investigators plain to use a heart rate variability biofeedback tool to measure stress reduction in hospitalized expectant mothers. This tool will be coupled with validated surveys and scales, high frequency heart rate variability, saliva samples, and qualitative interviews to quantify the reduction in stress from the HRVB tool.

Primary Outcome

The investigators will report rates of enrollment among women approached to join the study, rates of longitudinal data collection, and loss to follow-up.

Interventions

  • BEHAVIORAL Heart Rate Variability Biofeedback Tool

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2014-05
Est. Completion 2016-10
Phase NA

Why NCT02119936 stopped before completion

NCT02119936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Heart Rate Variability Biofeedback Tool is the first listed.

NCT02119936 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02119936 about?

NCT02119936 is a clinical study titled "Feasibility of Heart Rate Variability Biofeedback With In-patient Pregnant Women". Purpose: The investigators plan a feasibility study on an easily disseminated biofeedback tool to reduce stress among hospitalized and expecting mothers. Converging evident suggests that Heart Rate Variability Biofeedback (HRVB) can improve the threshold of stress management and improve executive fu...

What is the current status of trial NCT02119936?

This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2014-05. Estimated completion is 2016-10.

What interventions are being tested in trial NCT02119936?

The interventions under investigation include: Heart Rate Variability Biofeedback Tool (BEHAVIORAL).

Who is sponsoring clinical trial NCT02119936?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02119936's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02119936, the US trial registry maintained by the National Library of Medicine. NCT02119936 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.