Hypnose, Virtual Reality og deres kombination i knoglemarvsundersøgelse
Effektiviteten af registreret hypnose, Virtual Reality eller deres kombination hos patienter, der gennemgår en knoglemarvsundersøgelse på hæmatologisk afdeling
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Haifa, Israel, 3339419
- Bnai Zion Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Kontrol (C)
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Eksperimentel: 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. |
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. |
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Eksperimentel: 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. |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Symptoms experienced by patients undergoing bone marrow procedure
Tidsramme: Through study completion, an average of 1 hour
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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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Absorption, dissociation, immersion and time perception
Tidsramme: Through study completion, an average of 1 hour
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Validated questionnaire on absorption, dissociation, immersion and time perception |
Through study completion, an average of 1 hour
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Sedation
Tidsramme: Through study completion, an average of 1 hour
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Type and dose of sedation used during procedure |
Through study completion, an average of 1 hour
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Use of analgesics
Tidsramme: Through study completion, an average of 1 hour
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Type and dose of analgesics |
Through study completion, an average of 1 hour
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Blood pressure
Tidsramme: Through study completion, an average of 1 hour
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Blood pressure |
Through study completion, an average of 1 hour
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Pulse
Tidsramme: Through study completion, an average of 1 hour
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Pulse |
Through study completion, an average of 1 hour
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Respiratory rate
Tidsramme: Through study completion, an average of 1 hour
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Respiratory rate |
Through study completion, an average of 1 hour
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ilana Levy Yurkovski, MD, Bnai Zion Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0053-23-BNZ
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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