Impact of an Operating Room Nurse Pre-operative Dialogue... | NCT05237557

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

NCT05237557

Sponsor

Nicolas DEMARTINES

Status

Completed

Last Update Posted

Mar 2, 2022Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Anxiety
Post Operative Pain
Postoperative Nausea
Postoperative Complications
Satisfaction, Patient

Interventions

Preoperative nurse dialogue

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 9, 2020Actual

Primary Completion Date

Jun 29, 2020Actual

Completion Date

Dec 1, 2021Actual

First Submitted Date

Feb 2, 2022

First Submission Date that Met QC Criteria

Feb 2, 2022

First Posted Date

Feb 14, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2022

Last Update Posted Date

Mar 2, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicolas DEMARTINES, Head of Visceral Surgery Department, Professor of Surgery, University of Lausanne HospitalsSponsor-Investigator

Lead Sponsor

Nicolas DEMARTINESOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interventional group	Experimental		Behavioral: Preoperative nurse dialogue
Control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoperative nurse dialogue	Behavioral	Performance of a preoperative nurse dialogue prior major visceral surgery	Interventional group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Visceral Surgery, University Hospital CHUV, Lausanne		Lausanne		1011	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D010149	Pain, Postoperative
D020250	Postoperative Nausea and Vomiting
D011183	Postoperative Complications
D017060	Patient Satisfaction

Ancestor Terms

ID	Term
D001523	Mental Disorders
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided