Clinical trial NCT05982249: Hypnosis and Virtual Reality in Bone Marrow Examination
Official title: Effectiveness of Recorded Hypnosis and Virtual Reality in Patients Undergoing a Bone Marrow Examination at the Hematology Unit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Diseases
Keywords: Bone marrow
Procedure
Hematology
Hypnosis
Guided imagery
Virtual reality
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2023-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Symptoms experienced by patients undergoing bone marrow procedure
timeFrame: Through study completion, an average of 1 hour
Secondary outcomes:
measure: Absorption, dissociation, immersion and time perception
timeFrame: Through study completion, an average of 1 hour
measure: Sedation
timeFrame: Through study completion, an average of 1 hour
measure: Use of analgesics
timeFrame: Through study completion, an average of 1 hour
measure: Blood pressure
timeFrame: Through study completion, an average of 1 hour
measure: Pulse
timeFrame: Through study completion, an average of 1 hour
measure: Respiratory rate
timeFrame: Through study completion, an average of 1 hour
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Bnai Zion Medical Center
name: Ilana Levy Yurkovski, MD
role: PRINCIPAL_INVESTIGATOR
References: