Effect of Walking to the Operating Room on Preoperative Anxiety
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).
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Liège、ベルギー、4000
- Centre Hospitalier Universitaire de Liege
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Walk group
Patients walked to operating room (OR)
|
Patients, after being prepared for the OR, walk to the operating room
|
|
介入なし：Bed group
Patients go to OR while in bed
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Level of anxiety
時間枠：Preoperatively in the room
|
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
時間枠：Preoperatively in the room
|
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
|
Preoperatively in the room
|
|
Level of anxiety
時間枠：Preoperatively in front of OR
|
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
|
Preoperatively in front of OR
|
|
Level of anxiety
時間枠：Before departure of the outpatient unit
|
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
|
Before departure of the outpatient unit
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Level of pain
時間枠：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)
|
Within 1 hour after admission in the Post Anesthesia Care Unit after surgery
|
|
Level of pain
時間枠：Before departure of outpatient unit
|
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
|
Before departure of outpatient unit
|
|
Level of pain
時間枠：At Day 1
|
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
|
At Day 1
|
|
Presence of nausea and vomiting
時間枠：During the stay in the Post Anesthesia Care Unit after surgery assessed up to 12h
|
Yes or No
|
During the stay in the Post Anesthesia Care Unit after surgery assessed up to 12h
|
|
Presence of nausea and vomiting
時間枠：During the stay in the outpatient unit after surgery assessed up to 12h
|
Yes or no
|
During the stay in the outpatient unit after surgery assessed up to 12h
|
|
Presence of nausea and vomiting
時間枠：at Day 1
|
Yes or no
|
at Day 1
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Claude Hallet, MD、Centre Hospitalier Universitaire de Liege
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。