Hypnosis, Virtual Reality and Their Combination in Bone Marrow Examination

Study Overview
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Brief Summary
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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 4 groups: Hearing a 7-minutes hypnotic script via earphones Seeing and hearing virtual images and sounds via a virtual reality device during 7 minutes Both heating a 7-minutes hypnotic script via earphones and seeing virtual images via a virtual reality device 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.

Official Title
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Effectiveness of Recorded Hypnosis, Virtual Reality or Their Combination in Patients Undergoing a Bone Marrow Examination at the Hematology Unit

Conditions
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Hematologic Diseases

Intervention / Treatment
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* Device: Hypnosis
* Device: Virtual reality (VR)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis (H)<br>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. | Device: Hypnosis<br>* 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.<br>|
| Experimental: Virtual reality (VR)<br>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. | Device: Virtual reality (VR)<br>* 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.<br>|
| Experimental: Combined hypnosis and virtual reality (VRH)<br>Patients will hear the same 7-minutes hypnotic script by earphones and simultaneously be connected to the VR device that will show the 3D screen without soothing noise. | Device: Hypnosis<br>* 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.<br>Device: Virtual reality (VR)<br>* 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.<br>|
| No Intervention: Control (C)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow, Procedure, Hematology, Hypnosis, Guided imagery, Virtual reality