Impact of an Operating Room Nurse Pre-operative Dialogue in Patients Undergoing Major Visceral Surgery

February 12, 2022 updated by: Nicolas DEMARTINES

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, 1011
        • Department of Visceral Surgery, University Hospital CHUV, Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Interventional group
Behavioral: Preoperative nurse dialogue
Performance of a preoperative nurse dialogue prior major visceral surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative anxiety
Time Frame: 5-10 minutes after intervention
State-Trait Anxiety Inventory Form Y (STAI-Y)
5-10 minutes after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicolas DEMARTINES

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2020

Primary Completion (Actual)

June 29, 2020

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 12, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-00202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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