Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies (EASY-HD)
Evaluation of Anxiety Reduction in the Cathlab by Means of Pharmacological and Non-pharmacological Strategies: EASY-HD Pilot Study
The goal of this prospective pilot study is to learn if the use of virtual reality and/or relaxing soundscapes can help lower anxiety in adult patients undergoing a scheduled coronary angiography or angioplasty as compared to the standard of care. The main questions it aims to answer are:
- The use of non-pharmacological strategies reduces intraprocedural stress and anxiety compared to standard of care
- Reducing anxiety limits the use of pharmacological agents, which increases patient safety.
Researchers will compare the use of relaxing soundscapes or virtual reality to the standard of care to see the effects of these strategies on pain, anxiety and stress.
Participants will:
- listen to relaxing soundscapes, OR experience virtual reality including soundscapes OR standard of care during their procedure,
- Answer pain, anxiety and recovery questionnaires,
- Answer satisfaction questionnaires.
연구 개요
상태
상세 설명
The EASY-HD project is a prospective, randomized, controlled pilot study to evaluate the effectiveness of immersive nonpharmacological strategies, soundscapes, and virtual reality (VR) on the reduction of intraprocedural anxiety and stress in patients undergoing a scheduled hemodynamic intervention (coronary angiography and/or angioplasty).
Adult patients will be included and randomized into three parallel groups (1:1:1): standard of care alone (control group), standard of care combined with relaxing soundscapes via headphones, or standard of care combined with virtual reality immersion in a soothing environment including sound. The devices will be set up 5 to 10 minutes before the procedure and continued througout.
This minimal-risk study aims to determine the feasibility and potential clinical benefit of these simple, reproducible non-pharmacological approaches to improve patient comfort and possibly reduce the need for hemodynamic sedation.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Michele Jadin
- 전화번호: 4186568711
- 이메일: michele.jadin@criucpq.ulaval.ca
연구 장소
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Quebec
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Québec, Quebec, 캐나다, G1V 4G5
- IUCPQ
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수석 연구원:
- Olivier F Bertrand, MD, PhD
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연락하다:
- Michele Jadin
- 전화번호: 418-656-8711
- 이메일: michele.jadin@criucpq.ulaval.ca
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults, 18 years or older
- Scheduled hemodynamic intervention (coronary angiography and/or angioplasty)
- Patient willing and able to understand the study
- Signed informed consent
Exclusion Criteria:
- Scheduled complex procedure (CTO, structural)
- Severe cognitive or psychiatric disorders
- Major hearing/visual impairment
- Severe motion sickness or history of malaise with Virtual Reality (VR)
- Complaints of nausea or vomiting
- History of epilepsy
- Claustrophobia
- Facial injuries
- In clinical isolation (infection control)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Control
Standard of care analgesic and anxiolytic therapy
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실험적: Auditive experience
A pre-defined non-invasive audio experience using relaxing soundscapes via headphones will be used along standard of care pain and anxiety-relief medication (on patient's demand).
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Auditive distraction therapy
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실험적: Immersion experience
A pre-defined virtual-reality led audiovisual experience will be used along standard of care pain and anxiety-relief medication (on patient's demand).
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Virtual reality-lead audiovisual experience
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in patient-reported anxiety
기간: Baseline (preprocedural), periprocedural and at one-week follow-up
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Change from baseline in patient reported anxiety evaluated by anxiety questionnaires Visual Analog Score for anxiety (0 = Not anxious at all - 10 = Extremely anxious) |
Baseline (preprocedural), periprocedural and at one-week follow-up
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Change in patient-reported anxiety
기간: Baseline, Periprocedural, and at one-week follow-up
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Change from baseline in patient reported anxiety evaluated by anxiety questionnaires State-Trait Anxiety Invetory for Adults - 6 item short form |
Baseline, Periprocedural, and at one-week follow-up
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Change in patient-reported pain
기간: Baseline, periprocedural and at one-week follow-up
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Change from baseline in patient reported pain evaluated by pain questionnaires Visual Analog Scale for pain (0=No pain - 10 = Worst pain possible) |
Baseline, periprocedural and at one-week follow-up
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Use of analgesic and anxiolytic medications
기간: Within 48 hours before and after the procedure
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Use vs no-use of analgesic (opioid/non-opioid) and/or anxiolytic medication. If analgesic and/or anxiolytic medication is used, its type, dose and frequency will be registered. |
Within 48 hours before and after the procedure
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Change from baseline in physiological factors associated with pain and anxiety - Heart Rate
기간: Baseline, periprocedural
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Heart rate (beats per minute)
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Baseline, periprocedural
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Change from baseline in physiological factors associated with pain and anxiety - Respiratory Rate
기간: Baseline, periprocedural
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Respiratory rate (breaths per minute)
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Baseline, periprocedural
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Change from baseline in physiological factors associated with pain and anxiety - Blood Pressure
기간: Baseline, Periprocedural
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Blood pressure (mmHg)
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Baseline, Periprocedural
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Incidence of adverse events of interest
기간: Within 10 days of the procedure
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Patient-reported nausea, dizziness and increased anxiety will be collected
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Within 10 days of the procedure
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Incidence of adverse cardiac events
기간: Within 10 days of the procedure
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Within 10 days of the procedure
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EASY-HD
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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