Process evaluation in randomised controlled trials of complex interventions.
Ann Oakley, Vicki Strange, Chris Bonell...
https://pubmed.ncbi.nlm.nih.gov/16484270Actively Recruiting
Led by ORNND - Operating Room Nurse Network Denmark ยท Updated on 2026-04-20
135
Participants Needed
3
Research Sites
43 weeks
Total Duration
O
ORNND - Operating Room Nurse Network Denmark
Lead Sponsor
R
Rigshospitalet, Denmark
Collaborating Sponsor
This research aims to improve the wellbeing and resilience of operating room (OR) staff by studying the effects of structured postoperative team debriefings. The study focuses on how these debriefings impact team performance, psychological safety, and non-technical skills in the OR. It compares debriefings supported with audio and video recordings from an Operating Room Black Box system to those without such augmented data, addressing the challenge of occupational stress and burnout among healthcare workers in surgical settings. The study is an international quasi-experimental comparison conducted in three university hospitals across Denmark, the Netherlands, and Germany. Teams performing elective daytime surgeries use a six-step debriefing model led by an independent moderator. One group uses debriefings augmented with 2-4 video clips and data from the OR Black Box system, while the control group debriefs without this augmented content. All participants complete questionnaires before and after surgery, and debriefings are audio recorded and observed for detailed analysis. Participants are involved over about one month per team within a one-year intervention period, taking part in questionnaires, observed debriefings, and some qualitative interviews afterward. Researchers collect data through recordings, observations, and validated questionnaires measuring psychological safety, team effectiveness, and quality of life. The study aims to develop strategies to enhance communication, safety, and teamwork in the OR, with voluntary participation and data stored securely following regulations.
CONDITIONS
Operating Room Black Box Supported Debriefings and Their Effect on Healthcare Professionals Effectiveness and Psychological Safety.
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) to provide consent and confirm eligibility
Duration - 1 month
Participants engage in team debriefings after surgery, focusing on reflection, psychological safety, and problem solving with or without Operating Room Black Box support.
1 baseline questionnaire, surgery, short questionnaire within 12 hours after surgery, and 1 debriefing visit within 5 to 21 days after surgery
Duration - 1 to 3 months
Participants complete a follow-up questionnaire and a sample may participate in qualitative interviews to assess psychological safety and satisfaction with the debriefings.
1 follow-up questionnaire and possible qualitative interview visit
Total: 3 locations
1
Copenhagen University Hospital, Denmark
Copenhagen, Denmark, 2100
Actively Recruiting
2
University Hospital UKE
Hamburg, Germany
Not Yet Recruiting
3
University Hospital AUMC
Amsterdam, Netherlands
Not Yet Recruiting
J
Johanne S Hartmann, RN, MScN
J
Jeanett Strandbygaard, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
4
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