鎮静なし大腸内視鏡検査中の痛みと不安を軽減するための言語的提案
鎮静剤を使用せずに患者の快適性を向上させる：大腸内視鏡検査中の不安と痛みに対する言語的暗示の影響
Colonoscopy is an important diagnostic and screening procedure for colorectal diseases, but it can cause pain and anxiety, especially when performed without sedation. Verbal suggestion techniques - in which the physician provides calm, positive, and encouraging communication during the procedure - may help reduce these unpleasant experiences.
This randomized controlled study aims to evaluate the effect of verbal suggestion on pain and anxiety levels of patients undergoing unsedated colonoscopy. Sixty adult patients will be randomly assigned to either a verbal suggestion group or a control group. In the verbal suggestion group, the endoscopist will use positive and supportive phrases during the procedure (for example: "You are doing great," "Take a deep breath, we'll get through this easily"). The control group will undergo colonoscopy without any verbal intervention.
Pain will be assessed using a Visual Analog Scale (VAS) and anxiety will be measured with the Beck Anxiety Inventory (BAI) before and after the procedure. Heart rate will also be monitored as an objective indicator of anxiety.
The goal of this study is to determine whether verbal suggestion can improve patient comfort and tolerance during colonoscopy without sedation, potentially providing a low-cost and practical method to enhance patient experience.
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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Yenimahalle
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Ankara、Yenimahalle、トルコ（Türkiye）、06500
- Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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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:
- Adults aged 18 to 70 years.
- Patients scheduled for elective, diagnostic, or screening colonoscopy without sedation.
- Ability to understand and provide written informed consent.
- Ability to communicate verbally with the endoscopist during the procedure.
- ASA (American Society of Anesthesiologists) physical status classification I-II.
Exclusion Criteria:
- Refusal or inability to provide informed consent.
- Known psychiatric or neurological disorders that could affect anxiety or pain perception.
- Use of anxiolytic, sedative, or analgesic drugs within 24 hours before the procedure.
- Colonoscopy performed under sedation or anesthesia.
- Severe cardiopulmonary comorbidities (ASA class ≥ III).
- Incomplete colonoscopy due to technical or anatomical reasons.
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 |
|---|---|
|
実験的：Verbal Suggestion Group
Patients undergoing unsedated colonoscopy will receive positive verbal suggestion from the endoscopist throughout the procedure (e.g., "You are doing great," "Take a deep breath," "It will be over soon.") |
During unsedated colonoscopy, the endoscopist will use positive verbal suggestions aimed at reducing patients' anxiety and perceived pain. The phrases include encouraging and calming statements such as "You are doing well," "Take a deep breath," and "We're almost done." The communication is supportive, consistent, and non-directive throughout the procedure. |
|
介入なし：Control Group
Patients undergoing unsedated colonoscopy will receive standard communication without verbal suggestion during the procedure. |
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 |
|---|---|---|
|
Change in anxiety level before and after colonoscopy
時間枠：Immediately before and within 10 minutes after the procedure
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Anxiety will be assessed using the Beck Anxiety Inventory (BAI). BAI scores will be obtained immediately before the procedure and within 10 minutes after completion of the colonoscopy. Higher scores indicate greater anxiety. |
Immediately before and within 10 minutes after the procedure
|
|
Pain intensity during colonoscopy
時間枠：During colonoscopy
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Pain intensity will be assessed using an 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Pain scores will be recorded at 5 minutes after the start of the procedure and at 10-minute intervals thereafter during colonoscopy. |
During colonoscopy
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Heart rate during colonoscopy
時間枠：Before and during colonoscopy
|
Heart rate was recorded immediately before the procedure, at 5 minutes after the start of colonoscopy, and at 10-minute intervals thereafter during the procedure. |
Before and during colonoscopy
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Oxygen saturation (SpO₂) during colonoscopy
時間枠：Before and during colonoscopy
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Peripheral oxygen saturation (SpO₂) was recorded immediately before the procedure, at 5 minutes after the start of colonoscopy, and at 10-minute intervals thereafter during the procedure. |
Before and during colonoscopy
|
協力者と研究者
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。