Effectiveness of Recorded Hypnosis and Virtual Reality in Patients Undergoing a Bone Marrow Examination at the Hematology Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Symptoms experienced by patients undergoing bone marrow procedure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Major hearing impairment
- •Major visual impairment.
结局指标
主要结局
Symptoms experienced by patients undergoing bone marrow procedure
时间窗: 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
次要结局
- Sedation(Through study completion, an average of 1 hour)
- Absorption, dissociation, immersion and time perception(Through study completion, an average of 1 hour)
- Use of analgesics(Through study completion, an average of 1 hour)
- Blood pressure(Through study completion, an average of 1 hour)
- Pulse(Through study completion, an average of 1 hour)
- Respiratory rate(Through study completion, an average of 1 hour)