Back to resultsImpact of an Operating Room Nurse Pre-operative Dialogue in Patients Undergoing Major Visceral Surgery
Primary Purpose
Anxiety, Post Operative Pain, Postoperative Nausea
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Preoperative nurse dialogue
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety
Eligibility Criteria
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
Sites / Locations
- Department of Visceral Surgery, University Hospital CHUV, Lausanne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Preoperative anxiety
State-Trait Anxiety Inventory Form Y (STAI-Y)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05237557
Brief Title
Impact of an Operating Room Nurse Pre-operative Dialogue in Patients Undergoing Major Visceral Surgery
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 9, 2020 (Actual)
Primary Completion Date
June 29, 2020 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicolas DEMARTINES
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Post Operative Pain, Postoperative Nausea, Postoperative Complications, Satisfaction, Patient
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center, Open-label, Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Preoperative nurse dialogue
Intervention Description
Performance of a preoperative nurse dialogue prior major visceral surgery
Primary Outcome Measure Information:
Title
Preoperative anxiety
Description
State-Trait Anxiety Inventory Form Y (STAI-Y)
Time Frame
5-10 minutes after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Visceral Surgery, University Hospital CHUV, Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of an Operating Room Nurse Pre-operative Dialogue in Patients Undergoing Major Visceral Surgery
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