催眠、虚拟现实及其组合在骨髓检查中的应用
记录的催眠、虚拟现实或其组合对在血液科接受骨髓检查的患者的有效性
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Haifa、以色列、3339419
- Bnai Zion Medical Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：控制（C）
|
|
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实验性的：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. |
|
实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Symptoms experienced by patients undergoing bone marrow procedure
大体时间：Through study completion, an average of 1 hour
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Absorption, dissociation, immersion and time perception
大体时间：Through study completion, an average of 1 hour
|
Validated questionnaire on absorption, dissociation, immersion and time perception |
Through study completion, an average of 1 hour
|
|
Sedation
大体时间：Through study completion, an average of 1 hour
|
Type and dose of sedation used during procedure |
Through study completion, an average of 1 hour
|
|
Use of analgesics
大体时间：Through study completion, an average of 1 hour
|
Type and dose of analgesics |
Through study completion, an average of 1 hour
|
|
Blood pressure
大体时间：Through study completion, an average of 1 hour
|
Blood pressure |
Through study completion, an average of 1 hour
|
|
Pulse
大体时间：Through study completion, an average of 1 hour
|
Pulse |
Through study completion, an average of 1 hour
|
|
Respiratory rate
大体时间：Through study completion, an average of 1 hour
|
Respiratory rate |
Through study completion, an average of 1 hour
|
合作者和调查者
调查人员
- 首席研究员：Ilana Levy Yurkovski, MD、Bnai Zion Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.