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Clinical Trials/NCT04908527
NCT04908527
Completed
Not Applicable

Effect of Walking to the Operating Room on Preoperative Anxiety in Patients Scheduled for Outpatient Laser Therapy for Venous Insufficiency: A Monocentric Randomized Study

University of Liege1 site in 1 country100 target enrollmentMay 15, 2019
ConditionsVein, Varicose

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vein, Varicose
Sponsor
University of Liege
Enrollment
100
Locations
1
Primary Endpoint
Level of anxiety
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The operating room environment can be a source of anxiety for the patient, including in the context of outpatient surgery for which anxiolytic medication is rarely used. This anxiety-induced effect can be reinforced by the patient's lack of active participation.

Some studies have already shown the feasibility of patient walking to the operating room (OR) and advantages this approach(Kojima and Ina 2002; Lack 2016; Nagraj et al. 2006).

Moreover, recovery room complications and pain have also been shown to be greater after varicose vein surgery in patients with significant preoperative anxiety (Scavee et al. 2016).

Therefore, the investigators decided to test the effects of walking to OR for patients admitted for outpatient surgery for varicose vein surgery.

Registry
clinicaltrials.gov
Start Date
May 15, 2019
End Date
November 21, 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claude Hallet

Principal investigator

University of Liege

Eligibility Criteria

Inclusion Criteria

  • Outpatient minimal invasive laser therapy for venous insufficiency

Exclusion Criteria

  • Inpatient surgery
  • Invasive surgery
  • Need for premedication
  • Use of walking aid
  • Non-French speaking patient
  • Patient refusal

Outcomes

Primary Outcomes

Level of anxiety

Time Frame: Before departure of the outpatient unit

Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)

Secondary Outcomes

  • Level of pain(At Day 1)
  • Presence of nausea and vomiting(at Day 1)

Study Sites (1)

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