NCT05237557CompletedNot Applicable
Impact of an Operating Room Nurse Pre-operative Dialogue on Anxiety, Satisfaction and Early Postoperative Outcomes in Patients Undergoing Major Visceral Surgery - a Single Center, Open-label, Randomized Controlled Trial
Nicolas DEMARTINES1 site in 1 country35 target enrollmentStarted: January 9, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Preoperative anxiety
Study Overview
Brief Summary
Single-center, open label, randomized controlled trial of a preoperative nursing dialogue in patient undergoing major visceral surgery aiming in evaluating its impact on patients' anxiety, satisfaction and early postoperative outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient undergoing elective major visceral surgery
- •Hospitalization the day before surgery
- •Sufficient command of French language
Exclusion Criteria
- •emergency procedures (after unplanned admission)
- •inability to obtain informed consent or refusal
- •inability to follow intervention
Arms & Interventions
Control group
No Intervention
Interventional group
Experimental
Intervention: Preoperative nurse dialogue (Behavioral)
Outcomes
Primary Outcomes
Preoperative anxiety
Time Frame: 5-10 minutes after intervention
State-Trait Anxiety Inventory Form Y (STAI-Y)
Secondary Outcomes
No secondary outcomes reported
Investigators
Nicolas DEMARTINES
Head of Visceral Surgery Department, Professor of Surgery
University of Lausanne Hospitals
Study Sites (1)
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