골수 검사에서 최면, 가상 현실 및 이들의 조합
혈액학 병동에서 골수 검사를 받는 환자에서 기록된 최면, 가상 현실 또는 이들의 조합의 효과
The goal of this clinical trial is to compare the effects of hypnosis, virtual reality or their combination in patients undergoing a bone marrow procedure.
The main question it aims to answer is whether such interventions may relieve anxiety and other symptoms described by patients undergoing the procedure.
Before the bone marrow procedure and after being explained on the study and signing informed consent, the nurse will measure vital signs and participants will fill-out a 2-minutes' questionnaire and will be assigned to one of 3 groups:
- Hearing a 7-minutes hypnotic script via earphones
- Seeing and hearing virtual images and sounds via a virtual reality device during 7 minutes
- None of these After these interventions or 10 minutes after assignation for patients not receiving intervention, patients will fill questionnaires again (about 5 minutes for filling the 2 questionnaires) and vital signs will be measured again. Then the bone marrow procedure will be performed. After the bone marrow procedure, the participants will fill-out another 2-minutes questionnaire and vital signs will be measured by the nurse.
Researchers will compare hypnotic script, virtual reality, their combination or none of them to see if they can affect anxiety and other complaints in patients undergoing a bone marrow procedure.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Haifa, 이스라엘, 3339419
- Bnai Zion Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 or older
- Candidate for a BM examination at the hematology unit
- Ability to answer questionnaires in Hebrew, Arabic or Russian
- Informed consent form signing
Exclusion Criteria:
- Major hearing impairment
- Major visual impairment.
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: 컨트롤(C)
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실험적: Hypnosis (H)
Patients will be given earphones to hear a hypnotic script that was recorded by Dr. Zahi Arnon, a psychologist specializing in hypnosis after observing about ten bone marrow (BM) examinations at the hematology institute. The length of the recording is about 7 minutes. |
Patients will be given earphones to hear a hypnotic script that was recorded by Dr. Zahi Arnon, a psychologist specializing in hypnosis after observing about ten BM examinations at the hematology institute. The length of the recording is about 7 minutes. |
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실험적: Virtual reality (VR)
Patients will be connected to a VR device that will transmit to the patient's choice a 3D screen and soothing noise for about 7 minutes. |
Patients will be connected to a VR device that will transmit to the patient's choice a 3D screen and soothing noise for about 7 minutes. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Symptoms experienced by patients undergoing bone marrow procedure
기간: Through study completion, an average of 1 hour
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Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire: requires participants to nominate one or two concerns and, using a seven-point scale from 0 (worse outcome) to 6 (best outcome), to score these concerns and their general feeling of wellbeing |
Through study completion, an average of 1 hour
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Absorption, dissociation, immersion and time perception
기간: Through study completion, an average of 1 hour
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Validated questionnaire on absorption, dissociation, immersion and time perception |
Through study completion, an average of 1 hour
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Sedation
기간: Through study completion, an average of 1 hour
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Type and dose of sedation used during procedure |
Through study completion, an average of 1 hour
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Use of analgesics
기간: Through study completion, an average of 1 hour
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Type and dose of analgesics |
Through study completion, an average of 1 hour
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Blood pressure
기간: Through study completion, an average of 1 hour
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Blood pressure |
Through study completion, an average of 1 hour
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Pulse
기간: Through study completion, an average of 1 hour
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Pulse |
Through study completion, an average of 1 hour
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Respiratory rate
기간: Through study completion, an average of 1 hour
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Respiratory rate |
Through study completion, an average of 1 hour
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ilana Levy Yurkovski, MD, Bnai Zion Medical Center
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. .