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Recruiting NCT07396675

NCT07396675 Operating Room Black Box Supported Debriefings and Their Effect on Healthcare Professionals Effectiveness and Psychological Safety.

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Clinical Trial Summary
NCT ID NCT07396675
Status Recruiting
Phase
Sponsor ORNND - Operating Room Nurse Network Denmark
Condition Stress
Study Type INTERVENTIONAL
Enrollment 135 participants
Start Date 2026-03-01
Primary Completion 2026-12-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Debriefing

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 135 participants in total. It began in 2026-03-01 with a primary completion date of 2026-12-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This study is enrolled in the European KEEPCARING Project. KEEPCARING aims to (re-)build wellbeing and resilience of healthcare workforce in EU hospitals by co-creating a multi-faceted non-digital, digital, and AI-supported solution package to prevent burnout among (aspirant) healthcare professionals on the individual, team, and organizational level. This study specifically investigate the operating room staff wellbeing and resilience. The healthcare system is currently struggling to retain and attract operating room personnel. A factor of importance to consider here is occupational stress. If not recognized or mitigated well, occupational stress and personal efficacy can eventually evolve into a syndrome labelled as 'burnout'. In addition, communication and resilience patterns between operating room staff members are of influence, poor and/or inadequate communication among staff may be a factor of stress, compromising their work and wellbeing. In contrast, communication patterns that have a high standard and clarity may support resilience. The ability to speak up and being able to advocate concerns of all team members is of the highest importance here. Indeed, psychological safety and effective teamwork patterns are key for the working environment, performance, patient safety, and job satisfaction. To prevent mistakes during surgery, a safe space where team members can freely speak up is vital. To improve psychological safety, and teamwork among OR staff, team debriefing after surgery is known to be effective. What is not known; is whether team debriefing with the additional support derived from audio- and video recordings of the surgery is equally effective as debriefing without. The objective of this study is to evaluate the impact of structured postoperative debriefings with and without procedural, structured audio- and video recordings, on team performance, psychological safety, and non-technical skills in the operating room. Specifically, this study aims to compare augmented debriefings with non-augmented debriefings, to assess differences in perceived usefulness, psychological safety, and observed improvements in teams' non-technical skills. This is an international quasi-experimental comparative study. The intervention consists of postoperative team debriefing using audio and video recordings ('augmented debriefing') from Operating Room Black Box system provided by Surgical Safety Technologies. The control group will have a postoperative team debriefing that is not augmented with Operating Room Black Box derived data. An identical debriefing template will be designed for both groups.

Eligibility Criteria

Inclusion Criteria: * Participants work in an OR-team at RIGS, AUMC or UKE. * Participants must have given informed written consent to participate in the study. * Participants must be in the OR for the majority of the procedure or/and have a central role in the teamwork. * At RIGS and AUMC participants for the ORBB debriefings must also be part of teams conducting surgeries in the OR where ORBB is installed (not all ORs have ORBB). * Participants can either be surgeons, anesthesiologist, anesthesia nurses, residents, OR-nurses, perfusionists, interns, nurse students or other OR-staff. Exclusion Criteria: * Visitors, guests, and other staff only watching the surgery, are excluded from participation. * Individuals who are unable or unwilling to provide written informed consent.

Contact & Investigator

Central Contact

Johanne S Hartmann, RN, MScN

✉ johanne.soeborg.hartmann@regionh.dk

📞 +4535450933

Frequently Asked Questions

Who can join the NCT07396675 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07396675 currently recruiting?

Yes, NCT07396675 is actively recruiting participants. Contact the research team at johanne.soeborg.hartmann@regionh.dk for enrollment information.

Where is the NCT07396675 trial being conducted?

This trial is being conducted at Copenhagen, Denmark, Hamburg, Germany, Amsterdam, Netherlands.

Who is sponsoring the NCT07396675 clinical trial?

NCT07396675 is sponsored by ORNND - Operating Room Nurse Network Denmark. The trial plans to enroll 135 participants.

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