TelesDystocia: Tele-Support vs. Cognitive Aid in Simulated Shoulder Dystocia
ConditionShoulder Dystocia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Training in shoulder dystocia management (McRoberts, suprapubic pressure, Gaskin) in the preceding six months
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Remote Tele-Support
Other interventionLive 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.
Cognitive Aid
Other interventionA 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.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Group A: Cognitive AidActive comparator 1 intervention
Group B: Group B: Remote Tele-SupportExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total performance score
Total performance score for the management of the standardized shoulder dystocia scenario (range 0-25 points; higher scores indicate better performance).
Time frame
At completion of the simulated shoulder dystocia scenarioSecondary outcomes
1
Cognitive load (NASA-TLX)
NASA Task Load Index (0-20 points across 6 subcategories; higher scores indicate higher cognitive load).
Time frame
Immediately after the simulated scenario2
Usability (System Usability Scale, SUS)
Usability of the randomized support tool measured on the System Usability Scale (10 items, 1-5 points each).
Time frame
Immediately after the simulated scenario3
Subjective experience (Likert)
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).
Time frame
Immediately after the simulated scenario4
Communication quality (Likert)
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)
Time frame
Immediately after the simulated scenarioSponsors and contacts
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Source ClinicalTrials.gov
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