Hypnos, virtuell verklighet och deras kombination i benmärgsundersökning
Effektiviteten av registrerad hypnos, virtuell verklighet eller deras kombination hos patienter som genomgår en benmärgsundersökning på hematologiska enheten
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Haifa, Israel, 3339419
- Bnai Zion Medical Center
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Kontroll (C)
|
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Experimentell: 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. |
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Symptoms experienced by patients undergoing bone marrow procedure
Tidsram: 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 |
Through study completion, an average of 1 hour
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Absorption, dissociation, immersion and time perception
Tidsram: Through study completion, an average of 1 hour
|
Validated questionnaire on absorption, dissociation, immersion and time perception |
Through study completion, an average of 1 hour
|
|
Sedation
Tidsram: Through study completion, an average of 1 hour
|
Type and dose of sedation used during procedure |
Through study completion, an average of 1 hour
|
|
Use of analgesics
Tidsram: Through study completion, an average of 1 hour
|
Type and dose of analgesics |
Through study completion, an average of 1 hour
|
|
Blood pressure
Tidsram: Through study completion, an average of 1 hour
|
Blood pressure |
Through study completion, an average of 1 hour
|
|
Pulse
Tidsram: Through study completion, an average of 1 hour
|
Pulse |
Through study completion, an average of 1 hour
|
|
Respiratory rate
Tidsram: Through study completion, an average of 1 hour
|
Respiratory rate |
Through study completion, an average of 1 hour
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ilana Levy Yurkovski, MD, Bnai Zion Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0053-23-BNZ
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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