Hypnosis and Virtual Reality in Bone Marrow Examination

Not Applicable

Recruiting

• Conditions: Hematologic Diseases
• Interventions: Device: Hypnosis; Device: Virtual reality (VR)

• Registration Number: NCT05982249
• Lead Sponsor: Bnai Zion Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-13
• Study First Submitted: 2023-07-16
• Study First Submitted QC: 2023-07-30
• Study First Posted: 2023-08-08
• Last Update Submitted: 2024-05-05
• Last Update Posted: 2024-05-07
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnosis (H)	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 bone marrow (BM) examinations at the hematology institute. The length of the recording is about 7 minutes.
Virtual reality (VR)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sedation	Through study completion, an average of 1 hour	Type and dose of sedation used during procedure
Absorption, dissociation, immersion and time perception	Through study completion, an average of 1 hour	Validated questionnaire on absorption, dissociation, immersion and time perception
Use of analgesics	Through study completion, an average of 1 hour	Type and dose of analgesics
Blood pressure	Through study completion, an average of 1 hour	Blood pressure
Pulse	Through study completion, an average of 1 hour	Pulse
Respiratory rate	Through study completion, an average of 1 hour	Respiratory rate

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel