TelesDystocia: Tele-Support vs. Cognitive Aid in Simulated Shoulder Dystocia (TelesDystocia)

August 17, 2026 updated by: Mathias Maleczek, Medical University of Vienna

TelesDystocia: A Randomized Controlled Simulation Trial Comparing Remote Tele-Support Versus a Standard Cognitive Aid for the Management of Shoulder Dystocia

Shoulder dystocia is an unpredictable, time-critical obstetric emergency requiring immediate recognition and rapid execution of established maneuvers. To date, there is no published evidence evaluating remote real-time support for the management of shoulder dystocia, which could be especially relevant for providers not frequently confronted with obstetric emergencies.

This prospective, randomized, controlled, simulation-based trial compares healthcare providers' performance in managing a standardized shoulder dystocia scenario when supported by remote tele-assistance versus a standard cognitive aid. Teams of at least two healthcare providers manage a standardized scenario on the Laerdal MamaBirthie Task Trainer, with a trained study team member playing the laboring patient. Successful delivery requires completion of three predefined external maneuvers and one internal maneuver.

Teams are randomized to Group A (cognitive aid: a standardized visual reference tool with written instructions and pictograms) or Group B (remote tele-support: live video guidance from a credentialed obstetric expert via Signal). The primary outcome is the total performance score (0-25 points). Secondary outcomes include cognitive load (NASA-TLX), usability (System Usability Scale), and subjective experience and communication quality (5-point Likert scales).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bernhard Rössler, MD

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion:

  • Adult healthy healthcare providers (paramedics, emergency physicians, midwives, nurses)
  • Working in teams of at least two persons
  • Fluent in German (the cognitive aid is provided in German)

Exclusion:

  • Training in shoulder dystocia management (McRoberts, suprapubic pressure, Gaskin) in the preceding six months
  • Not fluent in German

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Cognitive Aid
Teams manage the standardized shoulder dystocia scenario supported by a standardized visual cognitive aid (written instructions and pictograms of the required external and internal maneuvers). No additional clinical assistance is provided after scenario initiation.
Other: Cognitive Aid
A standardized visual reference tool provided at the start of the scenario, containing concise written instructions and pictograms illustrating the three required external maneuvers and the single internal maneuver. No additional clinical assistance is provided after scenario initiation.
Experimental: Group B: Remote Tele-Support
Teams manage the standardized shoulder dystocia scenario supported by live real-time video guidance from a credentialed obstetric expert via a study-issued mobile device using Signal.
Other: Remote Tele-Support
Live real-time video guidance provided by a credentialed obstetric expert (midwife or obstetrician) via a study-issued mobile device using Signal (GDPR-compliant secure video call) throughout the standardized shoulder dystocia scenario.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total performance score
Time Frame: At completion of the simulated shoulder dystocia scenario
Total performance score for the management of the standardized shoulder dystocia scenario (range 0-25 points; higher scores indicate better performance).
At completion of the simulated shoulder dystocia scenario

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive load (NASA-TLX)
Time Frame: Immediately after the simulated scenario
NASA Task Load Index (0-20 points across 6 subcategories; higher scores indicate higher cognitive load).
Immediately after the simulated scenario
Usability (System Usability Scale, SUS)
Time Frame: Immediately after the simulated scenario
Usability of the randomized support tool measured on the System Usability Scale (10 items, 1-5 points each).
Immediately after the simulated scenario
Subjective experience (Likert)
Time Frame: Immediately after the simulated scenario
Participants' subjective experience assessed using a 5-point Likert scale (range 1-5; higher scores indicate greater confidence in the shoulder dystocia algorithm and better perceived overall performance in the simulation).
Immediately after the simulated scenario
Communication quality (Likert)
Time Frame: Immediately after the simulated scenario
Quality of communication of the tele-support on a 5-point Likert scale, reported by the participant as well as by the expert.(range 1-5; higher scores indicate better quality of communication)
Immediately after the simulated scenario

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 25, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

July 31, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TelesDystocia_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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