Effect of Walking to the Operating Room on Preoperative Anxiety

Vein, Varicose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908527
• Other study ID #: 2019-122
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: November 21, 2019

Study information

• Verified date: May 2021
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 21, 2019
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins
• Vein, Varicose

Intervention

Behavioral:
• Walking to OR
Patients, after being prepared for the OR, walk to the operating room

Locations

Country	Name	City	State
Belgium	Centre hospitalier universitaire de Liege	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Level of anxiety	Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)	Preoperatively in the room
Primary	Level of anxiety	Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)	Preoperatively in front of OR
Primary	Level of anxiety	Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)	Before departure of the outpatient unit
Secondary	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
Secondary	Level of pain	Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)	Before departure of outpatient unit
Secondary	Level of pain	Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)	At Day 1
Secondary	Presence of nausea and vomiting	Yes or No	During the stay in the Post Anesthesia Care Unit after surgery assessed up to 12h
Secondary	Presence of nausea and vomiting	Yes or no	During the stay in the outpatient unit after surgery assessed up to 12h
Secondary	Presence of nausea and vomiting	Yes or no	at Day 1