Effect of Walking to the Operating Room on Preoperative Anxiety

Study Overview
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Brief Summary
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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.

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

Conditions
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Vein, Varicose

Intervention / Treatment
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* Behavioral: Walking to OR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walk group<br>Patients walked to operating room (OR) | Behavioral: Walking to OR<br>* Patients, after being prepared for the OR, walk to the operating room<br>|
| No Intervention: Bed group<br>Patients go to OR while in bed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of anxiety | French version of Preoperative Anxiety and Information Scale (APAIS) - Score between 6 (less anxious) and 30 (more anxious) | Preoperatively in the room | 
| Level of anxiety | Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety) | Preoperatively in the room | 
| Level of anxiety | Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety) | Preoperatively in front of OR | 
| Level of anxiety | Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety) | Before departure of the outpatient unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of pain | Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain) | Within 1 hour after admission in the Post Anesthesia Care Unit after surgery | 
| Level of pain | Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain) | Before departure of outpatient unit | 
| Level of pain | Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain) | At Day 1 | 
| Presence of nausea and vomiting | Yes or No | During the stay in the Post Anesthesia Care Unit after surgery assessed up to 12h | 
| Presence of nausea and vomiting | Yes or no | During the stay in the outpatient unit after surgery assessed up to 12h | 
| Presence of nausea and vomiting | Yes or no | at Day 1 |