Hypnosis and Virtual Reality in Bone Marrow Examination
ConditionHematologic Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBnai Zion Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Major hearing impairment
Major visual impairment.
Trial design
Design model
Parallel
Treatments tested in this trial
Hypnosis
DevicePatients 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.
Virtual reality (VR)
DevicePatients 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.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Hypnosis (H)Experimental treatment 1 intervention
Group B: Virtual reality (VR)Experimental treatment 1 intervention
Group C: Control (C)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Through study completion, an average of 1 hourSecondary outcomes
1
Absorption, dissociation, immersion and time perception
Validated questionnaire on absorption, dissociation, immersion and time perception
Time frame
Through study completion, an average of 1 hour2
Sedation
Type and dose of sedation used during procedure
Time frame
Through study completion, an average of 1 hour3
Use of analgesics
Type and dose of analgesics
Time frame
Through study completion, an average of 1 hour4
Blood pressure
Blood pressure
Time frame
Through study completion, an average of 1 hourSponsors and contacts
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Source ClinicalTrials.gov