Effect of Walking to the Operating Room on Preoperative Anxiety

NCT04908527 | Completed

• 1 other identifier: 2019-122
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vein, Varicose

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Level of pain

  Within 1 hour after admission in the Post Anesthesia Care Unit after surgery

• Level of pain

  Before departure of outpatient unit

• Level of pain

  At Day 1

• Presence of nausea and vomiting

  During the stay in the Post Anesthesia Care Unit after surgery assessed up to 12h

• Presence of nausea and vomiting

  During the stay in the outpatient unit after surgery assessed up to 12h

Study Arms (2)

Walk group

EXPERIMENTAL

Patients walked to operating room (OR)

Behavioral: Walking to OR

Bed group

NO INTERVENTION

Patients go to OR while in bed

Interventions

Walking to OR BEHAVIORAL

Patients, after being prepared for the OR, walk to the operating room

Walk group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient minimal invasive laser therapy for venous insufficiency

You may not qualify if:

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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Centre hospitalier universitaire de Liege

Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Claude Hallet, MD

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: June 1, 2021
• Study Start: May 15, 2019
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)