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NCT Number: NCT05982249

Hypnosis and Virtual Reality in Bone Marrow Examination

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.

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Key information

Conditions

Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bnai Zion Medical Center

Haifa, 3339419, Israel

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypnosis

Device

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)

Device

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 outcomes

  1. Symptoms experienced by patients undergoing bone marrow procedure

    Time frame: 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 outcomes

  1. Absorption, dissociation, immersion and time perception

    Time frame: Through study completion, an average of 1 hour

    Validated questionnaire on absorption, dissociation, immersion and time perception

  2. Sedation

    Time frame: Through study completion, an average of 1 hour

    Type and dose of sedation used during procedure

  3. Use of analgesics

    Time frame: Through study completion, an average of 1 hour

    Type and dose of analgesics

  4. Blood pressure

    Time frame: Through study completion, an average of 1 hour

    Blood pressure

  5. Pulse

    Time frame: Through study completion, an average of 1 hour

    Pulse

  6. Respiratory rate

    Time frame: Through study completion, an average of 1 hour

    Respiratory rate

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2023
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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