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

April 15, 2026 updated by: Johanne Søborg Hartmann, ORNND - Operating Room Nurse Network Denmark

Improving Postoperative Debriefings: the Added Value of Operating Room Black Box Supported Debriefings and Their Effect on Healthcare Professionals Perceived Effectiveness and Psychological Safety.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Design and setting This is an international quasi-experimental comparative study, following the guidelines for complex interventions in health. The intervention will be ORBB augmented team-debriefing after surgery. The control group will debrief after surgery without the assistance of the ORBB. An identical debriefing template has been designed for both groups.

This study will be conducted at OR departments in three university hospitals, located in three different countries: Rigshospitalet, Copenhagen University Hospital (RIGS), Amsterdam University Medical Center (AUMC) and University Medical Center Hamburg-Eppendorf (UKE). RIGS have nine OR's with ORBB installed and access to ORBB-generated video material and outcome reports using explainable AI. AUMC is expected to have two OR's with ORBB installed before beginning of study. RIGS and AUMC are planned as both interventions and control sites, AUMC will if unforeseen delays occur with ORBB installation, be a control site (e.g. have only non-augmented debriefings). UKE does not have ORBB and will be a control site.

Characteristics of the study population

Participants Full OR teams performing elective daytime surgeries, approximately 4-12 people per team. The teams will be selected from a variety of specialties such as cardiothoracic, gynecology, urology, abdominal, vascular, and orthopedic surgery. Depending on the variety and possibility at each site, RIGS, AUMC and UKE, including limitations due to which ORs have ORBB installed.

Intervention Investigators anticipate that the intervention of the study occurs over a 1-month period for each team. In total, the intervention period is scheduled over a one-year period within 2026. During all data collection team members speak in their native language, so for RIGS this is Danish, for AUMC Dutch and for UKE German. The intervention includes a baseline questionnaire, a surgery, a short questionnaire after surgery, an observed debriefing and a follow up questionnaire after surgery.

The intervention set up is the same for teams with and without ORBB, only difference is the audio and video from the ORBB and SST. Furthermore, the debriefings will be audio recorded, and a researcher will observe the sessions. After the intervention period, a sample of participants will be asked to participate in a qualitive interview study.

Preparation before team debriefing After surgery the OR team members individually fill out a short questionnaire. Team members will answer questions about the following four topics: overall procedure, teamwork, safety protocols and learning opportunities.

The key points are wide in their definitions purposely because the team members should have the possibility to choose meaningful moments from the actual OR situation within the four topics. They must answer the questionnaire within 12 hours after surgery, to secure that the OR episode is still fresh in their minds.

Afterwards the researcher on site will review the questionnaires and during non-augmented debriefings bring their answers into play. During augmented debriefings, the researcher will 'flag' the surgery within the SST platform and in collaboration with SST create 2-4 videoclips, that contains the key elements chosen by the team members.

Team debriefing The setup in both augmented and non-augmented debriefings focus on creating a dedicated learning environment that prioritizes reflection, open communication, and psychological safety during the sessions. The physical space is carefully designed to support these critical aspects of team learning and collaboration.

In every debriefing an independent educational specialist (with no formal or working relation to the OR) is used as a moderator that controls the conversation and follow the debriefing template.

During the debriefing a researcher observes the conversation and interactions between team members and the moderator. The observing researcher sits in a corner of the room, disturbing as little as possible, being quiet and only taking field notes of the interaction between the team members and the moderator. The debriefing sessions will be audio-recorded, and transcribed verbatim by the observing researcher.

The session is time-limited to 30-60 minutes, balancing comprehensive discussion with efficiency. Critically, the debriefing is ideally conducted after approximately 5 (to a maximum of 21 days) following the surgery, allowing team members sufficient time to process the experience while maintaining the immediacy of relevant insights and reflections emotionally and professionally.

At the same time, securing the researchers a timespan to overview the short questionnaires, and select key points, for the moderator to work with in the debriefing sessions. Specific for the ORBB augmented debriefings, at the same time securing a timespan for the researchers to select and prepare 2-4 videoclips within the ORBB platform in collaboration with SST before the debriefing.

Debriefing template for debriefing In this study investigators implement a six-step team debriefing model, tested with a high rate of participant satisfaction (7.8/10 rating) in a previous study on 35 ORBB augmented abdominal surgery team debriefing sessions. The researchers concluded that their proposed approach effectively facilitates OR debriefing across diverse healthcare settings and provides a viable framework for establishing a much-needed debriefing culture to enhance surgical team performance. Investigators adjusted the model with few moderations to fit both OR debriefings with and without ORBB augmented data, and to include more OR specialties, on top of abdominal OR teams.

During the debriefings the moderator controls the conversation, and every team member represents their field of expertise in the OR. The moderator follows the themes; experience, observation, analyze and application.

During the debriefings all teams will focus on psychological safety and problem solving within the following four key points: overall procedure, teamwork, safety protocols and learning opportunities. For the intervention sites, the debriefing templates are the same as the control site, only add on is the ORBB augmented material of 2-4 videoclips and objective data from SST platform, integrated into the debriefing templates.

Data and Outcomes Investigators will gather data about the debriefings and measure outcomes through the following measurement tools; observation and audio recording of team debriefings, individual pre- and post-debriefing questionnaires and qualitative interviews. Specifically for surgeries using the ORBB system, OR teams will also be observed through audio and video-review from ORBB, including AI statistical data provided by SST.

This will allow for in-depth analysis of team dynamics, providing a structured approach to understanding and improving collaborative practices in surgical settings. By capturing both quantitative ratings and qualitative insights, the research aims to develop targeted strategies that can elevate team communication, psychological safety, and overall performance.

Regulatory and ethics The coordinating hospital for this study is RIGS. In 2019, the Danish Data Protection Agency approved the overall ORBB project (registration no.: VD-2019-275). The project was submitted to the Regional Ethics Committee in 2018, and no ethical approval was needed (registration no.: H-18018801). Additional approval for this debriefing study has been obtained in 2025 from the Regional Legal and Ethics Committee in Copenhagen, Denmark, PRIVACY - legal GRC (ID-NUMBER: p-2025-19044).

Participation in this study is voluntary and thus consent based. All participants will receive oral and written information before entering the study, and they must sign a consent form to participate. Participants can withdraw their consent at any time. Data will be stored on certified servers of Zenodo, which complies with all regulations and applicable laws. Data will also be stored locally in the department's computer system drive.

Study Type

Interventional

Enrollment (Estimated)

135

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

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

No

Description

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.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Debriefings with Operating Room Black Box audio and video material
Operating Room Black Box audio and video material included in debriefings
Behavioral: Debriefing
Debriefing after surgery for operating room staff
Other: Debriefings without Operating Room Black Box audio and video material
Behavioral: Debriefing
Debriefing after surgery for operating room staff
Other: Observation of team debriefing
Observational study part of team member interaction during the team debriefing
Behavioral: Debriefing
Debriefing after surgery for operating room staff
Other: Qualitative interviews after team debriefing
Qualitative interview study part of team members after debriefing
Behavioral: Debriefing
Debriefing after surgery for operating room staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological safety
Time Frame: 1-3 months
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
Time Frame: 1-3 months
Usefulness and satisfaction of the team-debriefing, Van Dalen scale. 6 items score, minimum value 1, maximum value 5.
1-3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health and quality of life (Validated scale EQ-5D-3L)
Time Frame: 1-3 months
We include the following 3 dimensions from the EQ-5D-3L descriptive system; usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The participant is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the three dimensions.
1-3 months

Collaborators and Investigators

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

Sponsor

ORNND - Operating Room Nurse Network Denmark

Collaborators

Rigshospitalet, Denmark
Amsterdam UMC, location VUmc
Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

August 14, 2025

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEEPCARING EU Debriefing WP3

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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