Hypnosis and Virtual Reality in Bone Marrow Examination

Effectiveness of Recorded Hypnosis and Virtual Reality in Patients Undergoing a Bone Marrow Examination at the Hematology Unit

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Diseases
• Intervention / Treatment: Device: Hypnosis; Device: Virtual reality (VR)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dana Weizer; Phone Number: +972543295952; Email: dana.weizer@b-zion.org.il

Study Locations

• Israel
  • Haifa, Israel, 3339419
    • Recruiting
    • Bnai Zion Medical Center
    • Principal Investigator: Ilana Levy Yurkovski, MD
    • Sub-Investigator: Tamar Tadmor, MD
    • Contact: Ilana Levy Yurkovski, MD; Phone Number: +972525086128; Email: ilana.levy@b-zion.org.il
    • Sub-Investigator: Dina Libes, RN
    • Sub-Investigator: Nataly Kreiniz, MD
    • Sub-Investigator: Laila Hakhrush, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (C)
Experimental: Hypnosis (H); 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; 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.
Experimental: Virtual 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.	Device: Virtual 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Principal Investigator: Ilana Levy Yurkovski, MD, Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hypnosis; Hematology; Virtual reality; Bone marrow; Procedure; Guided imagery
• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: 0053-23-BNZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No