Vein, VaricoseNCT04908527
Effect of Walking to the Operating Room on Preoperative Anxiety
A study testing Walking to OR in people with Vein, Varicose, run by University of Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vein, Varicose
- What is being tested?
- Walking to OR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 15 May 2019to 21 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient minimal invasive laser therapy for venous insufficiency
Who cannot join
- Inpatient surgery
- Invasive surgery
- Need for premedication
- Use of walking aid
- Non-French speaking patient
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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
- Being tested
- Walking to OR
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking to ORBehavioural
Patients, after being prepared for the OR, walk to the operating room
| Study group | Role | What they receive |
|---|---|---|
| Walk group | Experimental | Patients walked to operating room (OR) Receives: Behavioral: Walking to OR |
| Bed group | No intervention | Patients go to OR while in bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of anxiety
French version of Preoperative Anxiety and Information Scale (APAIS) - Score between 6 (less anxious) and 30 (more anxious)
Measured: Preoperatively in the room
Level of anxiety
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Measured: Preoperatively in the room
Level of anxiety
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Measured: Preoperatively in front of OR
Level of anxiety
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Measured: Before departure of the outpatient unit
Secondary outcomes (6)
Level of pain
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
Measured: 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)
Measured: Before departure of outpatient unit
Level of pain
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
Measured: At Day 1
Presence of nausea and vomiting
Yes or No
Measured: During the stay in the Post Anesthesia Care Unit after surgery assessed up to 12h
Presence of nausea and vomiting
Yes or no
Measured: During the stay in the outpatient unit after surgery assessed up to 12h
Presence of nausea and vomiting
Yes or no
Measured: at Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start15 May 2019
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vein, VaricoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claude Hallet, University of Liege
- Investigators
- Claude Hallet, MD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908527
- Sponsor's protocol ID
- 2019-122
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04908527
- Acronym / sponsor ID
- 2019-122
- Conditions
- Vein, Varicose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walk group | Experimental | Behavioral: Walking to ORPatients walked to operating room (OR) |
| Bed group | No intervention | –Patients go to OR while in bed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatient minimal invasive laser therapy for venous insufficiency
Key exclusion criteria (6 listed)
- Inpatient surgery
- Invasive surgery
- Need for premedication
- Use of walking aid
- Non-French speaking patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking to ORPatients, after being prepared for the OR, walk to the operating room | Behavioural | Walk group |
Primary outcome
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)
Level of anxiety
Time frame: Preoperatively in the room
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Level of anxiety
Time frame: Preoperatively in front of OR
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
Level of anxiety
Time frame: Before departure of the outpatient unit
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
6 secondary outcomes
Level of pain
Time frame: Within 1 hour after admission in the Post Anesthesia Care Unit after surgery
Level of pain
Time frame: Before departure of outpatient unit
Level of pain
Time frame: At Day 1
Presence of nausea and vomiting
Time frame: During the stay in the Post Anesthesia Care Unit after surgery assessed up to 12h
Presence of nausea and vomiting
Time frame: During the stay in the outpatient unit after surgery assessed up to 12h
Presence of nausea and vomiting
Time frame: at Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claude Hallet, MD principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking to OR in people with Vein, Varicose, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of anxiety (time frame: Preoperatively in the room). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.