骨髄検査における催眠、仮想現実、およびそれらの組み合わせ
血液内科で骨髄検査を受ける患者における録音催眠、仮想現実、またはそれらの組み合わせの有効性
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Haifa、イスラエル、3339419
- Bnai Zion Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：コントロール(C)
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実験的：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Symptoms experienced by patients undergoing bone marrow procedure
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Absorption, dissociation, immersion and time perception
時間枠：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
|
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Sedation
時間枠：Through study completion, an average of 1 hour
|
Type and dose of sedation used during procedure |
Through study completion, an average of 1 hour
|
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Use of analgesics
時間枠：Through study completion, an average of 1 hour
|
Type and dose of analgesics |
Through study completion, an average of 1 hour
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Blood pressure
時間枠：Through study completion, an average of 1 hour
|
Blood pressure |
Through study completion, an average of 1 hour
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Pulse
時間枠：Through study completion, an average of 1 hour
|
Pulse |
Through study completion, an average of 1 hour
|
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Respiratory rate
時間枠：Through study completion, an average of 1 hour
|
Respiratory rate |
Through study completion, an average of 1 hour
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Ilana Levy Yurkovski, MD、Bnai Zion Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。