Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07772102
NA

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

Sponsor: Medical University of Vienna

View on ClinicalTrials.gov

Summary

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-08-25

Completion Date

2027-01-30

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

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.

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.

Locations (1)

Medical University of Vienna

Vienna, State of Vienna, Austria