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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypnosis (H) | Experimental | 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. |
|
| Virtual reality (VR) | Experimental | 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. |
|
| Control (C) | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms experienced by patients undergoing bone marrow procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Absorption, dissociation, immersion and time perception | Validated questionnaire on absorption, dissociation, immersion and time perception | Through study completion, an average of 1 hour |
| Sedation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dana Weizer | Contact | +972543295952 | dana.weizer@b-zion.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Ilana Levy Yurkovski, MD | Bnai Zion Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Medical Center | Recruiting | Haifa | 3339419 | Israel |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 5, 2023 | Jul 25, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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Open label randomized controlled trial
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| Virtual reality (VR) | Device | 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. |
|
Type and dose of sedation used during procedure
| Through study completion, an average of 1 hour |
| Use of analgesics | Type and dose of analgesics | Through study completion, an average of 1 hour |
| Blood pressure | Blood pressure | Through study completion, an average of 1 hour |
| Pulse | Pulse | Through study completion, an average of 1 hour |
| Respiratory rate | Respiratory rate | Through study completion, an average of 1 hour |
| D004191 |
| Behavioral Disciplines and Activities |