Hematologic Diseases
Conditions
Keywords
Bone marrow, Procedure, Hematology, Hypnosis, Guided imagery, Virtual reality
Brief summary
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.
Interventions
DEVICEHypnosis
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.
DEVICEVirtual 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.
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Open label randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. Candidate for a BM examination at the hematology unit 3. Ability to answer questionnaires in Hebrew, Arabic or Russian 4. Informed consent form signing
Exclusion criteria
1. Major hearing impairment 2. Major visual impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms experienced by patients undergoing bone marrow procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation | Through study completion, an average of 1 hour | Type and dose of sedation used during procedure |
| Use of analgesics | Through study completion, an average of 1 hour | Type and dose of analgesics |
| Absorption, dissociation, immersion and time perception | Through study completion, an average of 1 hour | Validated questionnaire on absorption, dissociation, immersion and time perception |
| Pulse | Through study completion, an average of 1 hour | Pulse |
| Respiratory rate | Through study completion, an average of 1 hour | Respiratory rate |
| Blood pressure | Through study completion, an average of 1 hour | Blood pressure |
Countries
Israel
Contacts
Primary ContactDana Weizer
Outcome results
None listed