Hypnosis and Virtual Reality in Bone Marrow Examination

Hematologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982249
• Other study ID #: 0053-23-BNZ
• Status: Recruiting
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: July 2026

Study information

• Verified date: July 2023
• Source: Bnai Zion Medical Center
• Contact: Dana Weizer
• Phone: +972543295952
• Email: dana.weizer[@]b-zion.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absorption, dissociation, immersion and time perception	Validated questionnaire on absorption, dissociation, immersion and time perception	Through study completion, an average of 1 hour
Secondary	Sedation	Type and dose of sedation used during procedure	Through study completion, an average of 1 hour
Secondary	Use of analgesics	Type and dose of analgesics	Through study completion, an average of 1 hour
Secondary	Blood pressure	Blood pressure	Through study completion, an average of 1 hour
Secondary	Pulse	Pulse	Through study completion, an average of 1 hour
Secondary	Respiratory rate	Respiratory rate	Through study completion, an average of 1 hour