Impact of an Operating Room Nurse Pre-operative Dialogue in Patients Undergoing Major Visceral Surgery
Sponsor
Nicolas DEMARTINES (Other)
Overall Status
Completed
CT.gov ID
NCT05237557
Collaborator
(none)
35
1
2
22.7
1.5
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Single center, Open-label, Randomized controlled trialSingle center, Open-label, Randomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Actual Study Start Date
:
Jan 9, 2020
Actual Primary Completion Date
:
Jun 29, 2020
Actual Study Completion Date
:
Dec 1, 2021
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Interventional group
|
Behavioral: Preoperative nurse dialogue
Performance of a preoperative nurse dialogue prior major visceral surgery
|
No Intervention: Control group
|
Outcome Measures
Primary Outcome Measures
- Preoperative anxiety [5-10 minutes after intervention]
State-Trait Anxiety Inventory Form Y (STAI-Y)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Department of Visceral Surgery, University Hospital CHUV, Lausanne | Lausanne | Switzerland | 1011 |
Sponsors and Collaborators
- Nicolas DEMARTINES
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nicolas DEMARTINES,
Head of Visceral Surgery Department, Professor of Surgery,
University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT05237557
Other Study ID Numbers:
- 2022-00202
First Posted:
Feb 14, 2022
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: