NCT Number: NCT05982249
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Haifa, 3339419, Israel
Location status: Recruiting
Dina Libes, RN
SUB_INVESTIGATOR
Ilana Levy Yurkovski, MD
CONTACT
Ilana Levy Yurkovski, MD
PRINCIPAL_INVESTIGATOR
Laila Hakhrush, MD
SUB_INVESTIGATOR
Nataly Kreiniz, MD
SUB_INVESTIGATOR
Tamar Tadmor, MD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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
Time frame: Through study completion, an average of 1 hour
Validated questionnaire on absorption, dissociation, immersion and time perception
Time frame: Through study completion, an average of 1 hour
Type and dose of sedation used during procedure
Time frame: Through study completion, an average of 1 hour
Type and dose of analgesics
Time frame: Through study completion, an average of 1 hour
Blood pressure
Time frame: Through study completion, an average of 1 hour
Pulse
Time frame: Through study completion, an average of 1 hour
Respiratory rate
Contact information is provided by the study sponsor or research team.
Bnai Zion Medical Center
Other Gov
Effectiveness of Recorded Hypnosis and Virtual Reality in Patients Undergoing a Bone Marrow Examination at the Hematology Unit
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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