Back to resultsEffect of Walking to the Operating Room on Preoperative Anxiety
Primary Purpose
Vein, Varicose
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Walking to OR
Sponsored by
About this trial
This is an interventional prevention trial for Vein, Varicose
Eligibility Criteria
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
Sites / Locations
- Centre hospitalier universitaire de Liege
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Walk group
Bed group
Arm Description
Patients walked to operating room (OR)
Patients go to OR while in bed
Outcomes
Primary Outcome Measures
Level of anxiety
French version of Preoperative Anxiety and Information Scale (APAIS) - Score between 6 (less anxious) and 30 (more anxious)
Level of anxiety
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Level of anxiety
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Level of anxiety
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Secondary Outcome Measures
Level of pain
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
Level of pain
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
Level of pain
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
Presence of nausea and vomiting
Yes or No
Presence of nausea and vomiting
Yes or no
Presence of nausea and vomiting
Yes or no
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04908527
Brief Title
Effect of Walking to the Operating Room on Preoperative Anxiety
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
November 21, 2019 (Actual)
Study Completion Date
November 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vein, Varicose
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walk group
Arm Type
Experimental
Arm Description
Patients walked to operating room (OR)
Arm Title
Bed group
Arm Type
No Intervention
Arm Description
Patients go to OR while in bed
Intervention Type
Behavioral
Intervention Name(s)
Walking to OR
Intervention Description
Patients, after being prepared for the OR, walk to the operating room
Primary Outcome Measure Information:
Title
Level of anxiety
Description
French version of Preoperative Anxiety and Information Scale (APAIS) - Score between 6 (less anxious) and 30 (more anxious)
Time Frame
Preoperatively in the room
Title
Level of anxiety
Description
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Time Frame
Preoperatively in the room
Title
Level of anxiety
Description
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Time Frame
Preoperatively in front of OR
Title
Level of anxiety
Description
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Time Frame
Before departure of the outpatient unit
Secondary Outcome Measure Information:
Title
Level of pain
Description
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
Time Frame
Within 1 hour after admission in the Post Anesthesia Care Unit after surgery
Title
Level of pain
Description
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
Time Frame
Before departure of outpatient unit
Title
Level of pain
Description
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
Time Frame
At Day 1
Title
Presence of nausea and vomiting
Description
Yes or No
Time Frame
During the stay in the Post Anesthesia Care Unit after surgery assessed up to 12h
Title
Presence of nausea and vomiting
Description
Yes or no
Time Frame
During the stay in the outpatient unit after surgery assessed up to 12h
Title
Presence of nausea and vomiting
Description
Yes or no
Time Frame
at Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Hallet, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier universitaire de Liege
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Walking to the Operating Room on Preoperative Anxiety
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