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

NCT07396675 | Recruiting

• 1 other identifier: KEEPCARING EU Debriefing WP3
• Study Type: interventional
• Target: 135
• Locations: 3 countries
• Sites: 3

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.

Conditions

Stress; Resilience; Psychological Safety; Burnout, Healthcare Workers; Teamwork

Keywords

debriefing; teamwork; psychological safety; operating room; operating room black box

Outcome Measures

Primary Outcomes (2)

• Psychological safety

  Amy Edmondsons Scale on psychological safety and learning behaviour in operating room teams. 7 items scale; minimum value 1, maximum value 5.

  1-3 months

• Usefulness and satisfaction of the team-debriefing

  Usefulness and satisfaction of the team-debriefing, Van Dalen scale. 6 items score, minimum value 1, maximum value 5.

  1-3 months

Secondary Outcomes (1)

• Health and quality of life (Validated scale EQ-5D-3L)

  1-3 months

Study Arms (4)

Debriefings with Operating Room Black Box audio and video material

OTHER

Operating Room Black Box audio and video material included in debriefings

Behavioral: Debriefing

Debriefings without Operating Room Black Box audio and video material

OTHER

Debriefings without Operating Room Black Box audio and video material

Behavioral: Debriefing

Observation of team debriefing

OTHER

Observational study part of team member interaction during the team debriefing

Behavioral: Debriefing

Qualitative interviews after team debriefing

OTHER

Qualitative interview study part of team members after debriefing

Behavioral: Debriefing

Interventions

Debriefing BEHAVIORAL

Debriefing after surgery for operating room staff

Debriefings with Operating Room Black Box audio and video material; Debriefings without Operating Room Black Box audio and video material; Observation of team debriefing; Qualitative interviews after team debriefing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Visitors, guests, and other staff only watching the surgery, are excluded from participation.
• Individuals who are unable or unwilling to provide written informed consent.

Sponsors & Collaborators

• ORNND - Operating Room Nurse Network Denmark: lead
• Rigshospitalet, Denmark: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Amsterdam UMC, location VUmc: collaborator

Study Sites (3)

Copenhagen University Hospital, Denmark

Copenhagen, 2100, Denmark

RECRUITING

University Hospital UKE

Hamburg, Germany

NOT YET RECRUITING

University Hospital AUMC

Amsterdam, Netherlands

NOT YET RECRUITING

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Related Links

• Burn out an occupational phenomen

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Johanne S Hartmann, RN, MScN

CONTACT

+4535450933; johanne.soeborg.hartmann@regionh.dk

Jeanett Strandbygaard, MD, PhD

CONTACT

jeanett.strandbygaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: February 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); DE (1); NL (1)