Effect of Walking to the Operating Room on Preoperative Anxiety

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

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.

Study Overview

• Status: Completed
• Conditions: Vein, Varicose
• Intervention / Treatment: Behavioral: Walking to OR

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire de Liège

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Principal Investigator: Claude Hallet, MD, Centre Hospitalier Universitaire de Liège

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Actual): November 21, 2019
• Study Completion (Actual): November 21, 2019

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 28, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: 2019-122

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