Sleep Deprivation Clinical Trial
— CAFISOfficial title:
Call-associated Acute Fatigue in Surgical Residency- Subjective Perception or Objective Fact?
Verified date | June 2008 |
Source | Philipps University Marburg Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study aimed to evaluate the effects of 24-Hour-Call-associated acute partial sleep deprivation on surgical residents` technical and cognitive performance in a virtual reality (VR) setting. Physiological parameters were used to quantify fatigue in respect to hours of sleep and subjective degrees of sleepiness. Technical performance and cognitive skills were assessed through low- and high fidelity tasks usig the VR- simulator LapSim. Objective alertness was measured by the standardized d2-Paper-Pencil-Test. Cited assessments were performed on three consecutive mornings- pre- and post-call as after 24 hours resting.
Status | Completed |
Enrollment | 38 |
Est. completion date | February 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 28 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Surgical interns, junior- or senior residents - Successful completion of a minimum of 10 basic VR- tasks with the VR- simulator LapSim: "camera navigation", "coordination", "clip applying", "Cutting", and "diathermy cutting" and a minimum of 5 sessions of advanced VR- tasks: "fine dissection", "intracorporal suturing" and "VR- cholecystectomy" - Voluntary participation - Written informed consent Exclusion Criteria: - Lack of required VR- training - Lack of informed consent |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Visceral-, Thoracic- and Vascular Surgery, Univeristy Hospital Giessen and Marburg- Location Marburg | Marburg | Hessen |
Lead Sponsor | Collaborator |
---|---|
Philipps University Marburg Medical Center |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical and cognitive performance | Technical and cognitive performance was assessed in a VR-setting of defined parameters of performance and the d2-Paper-Pencil-Test on three consecutive mornings- pre- and post call and after 24 hours resting. | 3 days | |
Secondary | Sleepiness and Fatigue | Sleepiness was assessed by Stanford Sleepiness Sclae (SSS) and fatigue was measured through pupillography and saliva cortisol concentration on three consecutive mornings- pre- and post call and after 24 hours resting. | 4 months |
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