Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies (NHYP)
Chimiotherapy produces neuropathies injuries to 30% to 70% cases. A third of those patients keeps suffering from this side effects disabilities and their quality of life is seriously affected.
Hypnosis, as a non-invasive tool without physical side effects, might be used to relieve them.
the purpose of this trial based on our own experience, is to demonstrate the value of using hypnosis and self-hypnosis in chimiotherapy- induced chronic neuropathies.
The aim will be to sustainably improve the quality of life by expanding self-management of pain and motor function side effect.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Anne Laudamy
- 電話番号:+33 3 88 11 66 88
- メール:anne.laudamy@chru-strasbourg.fr
研究連絡先のバックアップ
- 名前:anatta Razafimanantsoa
- 電話番号:+ 33 3 88 11 54 14
- メール:anatta.razafimanantsoa@chru-strasbourg.fr
研究場所
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Strabsourg、フランス、67091
- 募集
- University Strasbourg Hospital
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コンタクト:
- Raoul HERBRECHT, MD
- メール:raoul.herbrecht@chru-strasbourg.fr
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コンタクト:
- Caroline MAURER, Nurse
- メール:caroline.maurer@chru-strasbourg.fr
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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:
- Minimum age :18 years
- Chemiotherapy- induced chronic neuropathies for at least 2 months with a DN4 score >4
- Failure of classic treatment used to relief neuropathic
- Having stopped chemotherapy treatment and being in complete or partial response or in tumoral stability
- Without any planed chemiotherapy during the study
- Having signed a written informed consent.
- French efficient understanding
- With health insurance coverage
- availability during all the study
- With efficient contraception for women of childbearing age
Exclusion Criteria:
- No participation to another study at the same time
- Suffering from neuropathy before having chemotherapy
- Other disease that may cause neuropathy
- deafness
- Any medicine that could cause neuropathy
- Neurological or psychiatrical disease past or present
- Mental retardation
- Allergy to EMG's electrodes
- Unable to consent, under tutelage or curatorship or judiciary safeguard
- Pregnant or nursing woman
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:処理
- 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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プラセボコンパレーター:Nurse interview
Personal interview with nurses to evaluate the relief of neuropathic pains with the reference treatment.
(If necessary send to the medical team ) It's a listening time around neuropathic pain which altered the quality of life.
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Personal interview with nurses to evaluate the relief of neuropathic pains with the reference treatment.
(If necessary send to the medical team ) It's a listening time around neuropathic pain which altered the quality of life.
他の名前:
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実験的:Hypnosis session
Hypnosis sessions with nurses or psychologists, with deepening sessions to facilitate self-hypnosis learning.
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Hypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.
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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 |
時間枠 |
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Measure at 12 weeks (D84) benefits of hypnosis and self-hypnosis on the sensitive dimension of the quality of life of patients with chronic peripheral neuropathies arising from a cancer chemotherapy and inadequately relief with reference treatments.
時間枠:Day 84
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Day 84
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二次結果の測定
結果測定 |
時間枠 |
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Measure at 12 weeks (D84) benefits of hypnosis and self-hypnosis on the motor dimension of the quality of life of patients with chronic peripheral neuropathies arising from a cancer chemotherapy and inadequately relief with reference treatments.
時間枠:Day 84
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Day 84
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Measure at 12 weeks (D84) benefits of hypnosis and self-hypnosis on the loss of autonomy of patients with chronic peripheral neuropathies arising from a cancer chemotherapy and inadequately relief with reference treatments.
時間枠:Day 84
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Day 84
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Measure benefits of hypnosis on the neuropathic pain intensity
時間枠:Day 28, day 56 and Day 84.
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Day 28, day 56 and Day 84.
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Measure benefits of hypnosis on a psychotropic treatments
時間枠:Day 0, Day 28, day 56 and Day 84.
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Day 0, Day 28, day 56 and Day 84.
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Measure benefits of hypnosis on analgesic treatments
時間枠:Day 0, Day 28, day 56 and Day 84.
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Day 0, Day 28, day 56 and Day 84.
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Measure benefits of hypnosis on tendon reflexes, deep and superficial sensitivity, muscular strength
時間枠:Day 84
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Day 84
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Measure benefits of hypnosis on electrophysiological abnormalities related to neuropathy
時間枠:Day 84
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Day 84
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Measure benefits of hypnosis on self- hypnosis in the experimental group
時間枠:Day 28, Day 56 and D84
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Day 28, Day 56 and D84
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Evaluate the safety in the two arms, due to hypnosis adverse effects, to pain treatment or another reason
時間枠:Day 0, Day 28, Day 56, Day 84 and in case of serious adverse event
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Day 0, Day 28, Day 56, Day 84 and in case of serious adverse event
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協力者と研究者
捜査官
- スタディチェア:Caroline MAURER, Nurse、Strasbourg's University Hospitals
- 主任研究者:Raoul HERBRECHT, MD、Strasbourg's University Hospitals
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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。
Nurse interviewの臨床試験
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