Psychological Counselling in Diagnostic Screening
Management of Anxiety Related to Diagnostic Screenings: an Exploratory Pilot Study
調査の概要
詳細な説明
The Psychoeducative Training was organized in 6 weekly meetings lasting two hours. Each group was composed of 6 participants. The Training follows the cognitive-behavioural model. In the first part of every meeting, theoretical aspects about stress and anxiety were explained, while in the second part some relaxation techniques were taught. During relaxation, we used a selected music that was also going to be used during the diagnostic tests. Since the first meeting, patients experienced these relaxing techniques in order to learn them. In order to support the adaptability, at the end of every meeting the participants received some homework. They had to take notes on how many times they repeated the relaxation exercises and on the anxiety level before and after the training.
For the study, 43 people were recruited. Anxiety was measured with Beck Anxiety Inventory (BAI); it values the seriousness of the physiological behaviour connected with anxiety. This test an "anxiety gauge", which allows us to obtain numerical data on emotional changes. The test is composed of 4 interpretative levels: serious, moderate, small and minimal anxiety.
The coping style was measured with Coping Orientation to Problems Experienced-New Italian Version (COPE-NIV); this test evaluates the way in which people resolve and face traumatic or usual stressful situations.
The research project was approved by the Ethics Committee of Veneto Institute of Oncology.
Every patient signed a written informed consent to process the data for research purposes and to publish it.
Forty-three patients who had to undergo one or more diagnostic tests (PET, TAC, fMRI, Mammography, Endoscopy, Colonoscopy) took part in the study. The average age was 52.4 and 61.5% were married.
研究の種類
入学 (実際)
段階
- 適用できない
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: 25 to 65 years cancer patients who must undergo diagnostic tests: TAC, PET, fMRI, Mammography, Endoscopy and Colonoscopy.
- an anxiety level greater than 5 (in a scale from 0=very calm to 10=very anxious; using a self-reporting instrument created ad hoc)
- signed informed consent
Exclusion Criteria:
- healthy people
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：なし
- 介入モデル：単一グループの割り当て
- 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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実験的：Pilot group
Forty-three patients who had to undergo one or more diagnostic tests (PET, TAC, fMRI, Mammography, Endoscopy, Colonoscopy) took part in the study.
Most of the 43 patients had to undergo only one diagnostic test, and only 6 patients had more than one.
They have attended a psychoeducative training.
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The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of patients considered drop-outs
時間枠：6 weeks after recruitment (end of treatment)
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The proportion of patients considered drop-outs.
A patient is considered a drop-out if he/she does not attend at least 2 out of 6 programmed meetings.
This is a feasibility outcome
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6 weeks after recruitment (end of treatment)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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median BAI score after intervention
時間枠：6 weeks after recruitment (end of treatment)
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This is an efficacy outcome
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6 weeks after recruitment (end of treatment)
|
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median COPE score - Social support score after intervention
時間枠：6 weeks after recruitment (end of treatment)
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This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
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median COPE score - Avoidance strategies score after intervention
時間枠：6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
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median COPE score - Positive attitude score after intervention
時間枠：6 weeks after recruitment (end of treatment)
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This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
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median COPE score - Problem acceptance score after intervention
時間枠：6 weeks after recruitment (end of treatment)
|
This is an efficacy outcome
|
6 weeks after recruitment (end of treatment)
|
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recruitment time (process)
時間枠：6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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mean number of recruited patients per week (process)
時間枠：6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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refusal rate among eligible patients (process)
時間枠：6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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rate of patients who obviously meet and do not meet the eligibility requirements (process)
時間枠：6 weeks after recruitment (end of treatment)
|
This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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number of questionnaires correctly filled out (process)
時間枠：6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
|
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phone lines overloaded or waiting room overcrowded by study participants (management)
時間枠：6 weeks after recruitment (end of treatment)
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This is a feasibility outcome
|
6 weeks after recruitment (end of treatment)
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協力者と研究者
捜査官
- 主任研究者：Malihe Shams、Istituto Oncologico Veneto IRCCS
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
本研究に関する用語
その他の研究ID番号
- IOV-2012 ANXIETY
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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