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
  • Behavioral: Preoperative nurse dialogue
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

  1. 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:

Study Results

No Results Posted as of Mar 2, 2022