Hypnosis, Virtual Reality and Their Combination in Bone Marrow Examination

Sponsor

Bnai Zion Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05982249

Collaborator

(none)

100

Enrollment

Location

Arms

35.6

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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 4 groups:

Hearing a 7-minutes hypnotic script via earphones
Seeing and hearing virtual images and sounds via a virtual reality device during 7 minutes
Both heating a 7-minutes hypnotic script via earphones and seeing virtual images via a virtual reality device
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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Diseases	Device: Hypnosis Device: Virtual reality (VR)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Open label randomized controlled trialOpen label randomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effectiveness of Recorded Hypnosis, Virtual Reality or Their Combination in Patients Undergoing a Bone Marrow Examination at the Hematology Unit

Actual Study Start Date :

Jul 13, 2023

Anticipated Primary Completion Date :

Jul 1, 2026

Anticipated Study Completion Date :

Jul 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.
Experimental: Combined hypnosis and virtual reality (VRH) Patients will hear the same 7-minutes hypnotic script by earphones and simultaneously be connected to the VR device that will show the 3D screen without soothing noise.	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. 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.
No Intervention: Control (C)

Outcome Measures

Primary Outcome Measures

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

Absorption, dissociation, immersion and time perception [Through study completion, an average of 1 hour]
Validated questionnaire on absorption, dissociation, immersion and time perception
Sedation [Through study completion, an average of 1 hour]
Type and dose of sedation used during procedure
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