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NCT Number: NCT04908527

Effect of Walking to the Operating Room on Preoperative Anxiety

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.

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Key information

Conditions

Vein, Varicose Cardiovascular Diseases Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire de Liege

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking to OR

Behavioral

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

Primary outcomes

  1. Level of anxiety

    Time frame: Preoperatively in the room

    French version of Preoperative Anxiety and Information Scale (APAIS) - Score between 6 (less anxious) and 30 (more anxious)

  2. Level of anxiety

    Time frame: Preoperatively in the room

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

  3. Level of anxiety

    Time frame: Preoperatively in front of OR

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

  4. 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

  1. Level of pain

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

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

  2. Level of pain

    Time frame: Before departure of outpatient unit

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

  3. Level of pain

    Time frame: At Day 1

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

  4. Presence of nausea and vomiting

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

    Yes or No

  5. Presence of nausea and vomiting

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

    Yes or no

  6. Presence of nausea and vomiting

    Time frame: at Day 1

    Yes or no

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2021
Registry last updated
Jun 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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