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Hypnosis, Virtual Reality and Their Combination in Bone Marrow Examination

Primary Purpose

Hematologic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hypnosis
Virtual reality (VR)
Sponsored by
Bnai Zion Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematologic Diseases focused on measuring Bone marrow, Procedure, Hematology, Hypnosis, Guided imagery, Virtual reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Major hearing impairment Major visual impairment.

Sites / Locations

  • Bnai Zion Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Hypnosis (H)

Virtual reality (VR)

Combined hypnosis and virtual reality (VRH)

Control (C)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Absorption, dissociation, immersion and time perception
Validated questionnaire on absorption, dissociation, immersion and time perception
Sedation
Type and dose of sedation used during procedure
Use of analgesics
Type and dose of analgesics
Blood pressure
Blood pressure
Pulse
Pulse
Respiratory rate
Respiratory rate

Full Information

First Posted
July 16, 2023
Last Updated
July 30, 2023
Sponsor
Bnai Zion Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05982249
Brief Title
Hypnosis, Virtual Reality and Their Combination in Bone Marrow Examination
Official Title
Effectiveness of Recorded Hypnosis, Virtual Reality or Their Combination in Patients Undergoing a Bone Marrow Examination at the Hematology Unit
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2023 (Actual)
Primary Completion Date
July 2026 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bnai Zion Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Diseases
Keywords
Bone marrow, Procedure, Hematology, Hypnosis, Guided imagery, Virtual reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open label randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hypnosis (H)
Arm Type
Experimental
Arm Description
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.
Arm Title
Virtual reality (VR)
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined hypnosis and virtual reality (VRH)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control (C)
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Hypnosis
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual reality (VR)
Intervention Description
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 Measure Information:
Title
Symptoms experienced by patients undergoing bone marrow procedure
Description
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
Secondary Outcome Measure Information:
Title
Absorption, dissociation, immersion and time perception
Description
Validated questionnaire on absorption, dissociation, immersion and time perception
Time Frame
Through study completion, an average of 1 hour
Title
Sedation
Description
Type and dose of sedation used during procedure
Time Frame
Through study completion, an average of 1 hour
Title
Use of analgesics
Description
Type and dose of analgesics
Time Frame
Through study completion, an average of 1 hour
Title
Blood pressure
Description
Blood pressure
Time Frame
Through study completion, an average of 1 hour
Title
Pulse
Description
Pulse
Time Frame
Through study completion, an average of 1 hour
Title
Respiratory rate
Description
Respiratory rate
Time Frame
Through study completion, an average of 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Major hearing impairment Major visual impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Weizer
Phone
+972543295952
Email
dana.weizer@b-zion.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilana Levy Yurkovski, MD
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Levy Yurkovski, MD
Phone
+972525086128
Email
ilana.levy@b-zion.org.il
First Name & Middle Initial & Last Name & Degree
Ilana Levy Yurkovski, MD
First Name & Middle Initial & Last Name & Degree
Dina Libes, RN
First Name & Middle Initial & Last Name & Degree
Tamar Tadmor, MD
First Name & Middle Initial & Last Name & Degree
Nataly Kreiniz, MD
First Name & Middle Initial & Last Name & Degree
Laila Hakhrush, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypnosis, Virtual Reality and Their Combination in Bone Marrow Examination

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