NCT05237557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

February 2, 2022

Last Update Submit

February 12, 2022

Conditions

AnxietyPost Operative PainPostoperative NauseaPostoperative ComplicationsSatisfaction, Patient

Outcome Measures

Primary Outcomes (1)

  • Preoperative anxiety

    State-Trait Anxiety Inventory Form Y (STAI-Y)

    5-10 minutes after intervention

Study Arms (2)

Interventional group

EXPERIMENTAL
Behavioral: Preoperative nurse dialogue

Control group

NO INTERVENTION

Interventions

Preoperative nurse dialogueBEHAVIORAL

Performance of a preoperative nurse dialogue prior major visceral surgery

Interventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient undergoing elective major visceral surgery
  • Hospitalization the day before surgery
  • Sufficient command of French language

You may not qualify if:

  • emergency procedures (after unplanned admission)
  • inability to obtain informed consent or refusal
  • inability to follow intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral Surgery, University Hospital CHUV, Lausanne

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Anxiety DisordersPain, PostoperativePostoperative Nausea and VomitingPostoperative ComplicationsPatient Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomitingTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Single center, Open-label, Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Visceral Surgery Department, Professor of Surgery

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 14, 2022

Study Start

January 9, 2020

Primary Completion

June 29, 2020

Study Completion

December 1, 2021

Last Updated

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)