- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04908527
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Liège, 벨기에, 4000
- Centre Hospitalier Universitaire de Liege
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Walk group
Patients walked to operating room (OR)
|
Patients, after being prepared for the OR, walk to the operating room
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|
간섭 없음: Bed group
Patients go to OR while in bed
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Level of anxiety
기간: Preoperatively in the room
|
French version of Preoperative Anxiety and Information Scale (APAIS) - Score between 6 (less anxious) and 30 (more anxious)
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Preoperatively in the room
|
|
Level of anxiety
기간: Preoperatively in the room
|
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
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Preoperatively in the room
|
|
Level of anxiety
기간: 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
기간: Before departure of the outpatient unit
|
Numerical rating scale (NRS) between 0 (= no anxiety) and 10 (=worse anxiety)
|
Before departure of the outpatient unit
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Level of pain
기간: 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
기간: 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
기간: At Day 1
|
Numerical rating scale (NRS) between 0 (= no pain) and 10 (=worse pain)
|
At Day 1
|
|
Presence of nausea and vomiting
기간: 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
기간: 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
기간: at Day 1
|
Yes or no
|
at Day 1
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Claude Hallet, MD, Centre Hospitalier Universitaire de Liege
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .