Hypnosis and Virtual Reality in Bone Marrow Examination

NCT05982249 | Recruiting DMC

• 1 other identifier: 0053-23-BNZ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Diseases

Keywords

Bone marrow; Procedure; Hematology; Hypnosis; Guided imagery; Virtual reality

Outcome Measures

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

  Through study completion, an average of 1 hour

Secondary Outcomes (6)

• Absorption, dissociation, immersion and time perception

  Through study completion, an average of 1 hour

• Sedation

  Through study completion, an average of 1 hour

• Use of analgesics

  Through study completion, an average of 1 hour

• Blood pressure

  Through study completion, an average of 1 hour

• Pulse

  Through study completion, an average of 1 hour

Study Arms (3)

Hypnosis (H)

EXPERIMENTAL

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

Virtual reality (VR)

EXPERIMENTAL

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)

Control (C)

NO INTERVENTION

Interventions

Hypnosis DEVICE

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.

Hypnosis (H)

Virtual reality (VR) DEVICE

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.

Virtual reality (VR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major hearing impairment
• Major visual impairment.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, 3339419, Israel

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ilana Levy Yurkovski, MD

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dana Weizer

CONTACT

+972543295952; dana.weizer@b-zion.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Open label randomized controlled trial

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 8, 2023
• Study Start: July 13, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 7, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)