白内障手術中の患者に対する音楽とストレスボールの適用の影響
白内障手術中の患者に対する音楽とストレスボールの適用の効果 不安と痛みに対する効果を調べる
調査の概要
詳細な説明
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
-
-
-
Samsun、トルコ（Türkiye）
- Samsun Gazi State Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
包含基準:
- 18歳以上でPHACO手術を受けている方、
- 聴覚や知覚に問題がないのに、
- ストレスボールを握るほどの身体的な問題はなく、
- 初めて白内障の手術を受けましたが、
- 研究に積極的に参加できること。
除外基準:
- 手術前24時間以内の鎮痛薬または抗不安薬の使用。
- 手術中に局所麻酔から全身麻酔に移行し、
- 精神科の診断。
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Stress ball
Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward.
State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward.
Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II).
Patients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise.
The stress ball will be used for 15 minutes during cataract surgery.
Patients will be reminded during the procedure to continue the intervention as instructed.
|
Patients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise.
The stress ball will be used for 15 minutes during cataract surgery.
|
|
実験的：Music intervention
Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward.
State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward.
Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II).
According to the randomization, patients assigned to the music intervention group will be asked to select their preferred music from a prepared playlist.
The playlist will include 50 tracks representing pop music, Turkish classical music, regional folk music, instrumental music, and religious music.
The selected music will be played for 15 minutes during cataract surgery.
|
Patients assigned to the music intervention group will select their preferred music from a prepared playlist.
The selected music will be played for 15 minutes during cataract surgery.
|
|
介入なし：Control
Pain levels will be tested with VAS 10 minutes before the surgery, and anxiety levels with the VAS-A and Spielberg Continuous Anxiety Scale.
The patient in the control group will not be given any intervention.
|
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 |
|---|---|---|
|
痛み（ビジュアルアナログスケール）
時間枠：手術後10分
|
等級付けは、スケール上で長さ 10 cm の水平または垂直定規で行い、「0」は痛みがないことを意味し、「10」は最も激しい痛みを意味します。 患者は、定規で感じる痛みの強さをマークします。 マークされた値が 1 ～ 4 の場合は軽度の痛み、5 ～ 6 の場合は中程度の痛み、7 ～ 10 の場合は激しい痛みを示します。 アプリケーションでは、患者は定規で感じた痛みの強さをマークするように求められ、値が測定されて記録されました。 |
手術後10分
|
|
Pain (Visual Analog Scale)
時間枠：Immediately after surgery
|
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded. |
Immediately after surgery
|
|
Anxiety (Visual Analog Scale-Anxiety)
時間枠：approximately 5-10 minutes before surgery
|
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded. |
approximately 5-10 minutes before surgery
|
|
Anxiety (Visual Analog Scale-Anxiety)
時間枠：Immediately after surgery
|
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded. |
Immediately after surgery
|
|
Anxiety (Visual Analog Scale-Anxiety)
時間枠：10 minutes after surgery
|
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded. |
10 minutes after surgery
|
|
State-Trait Anxiety Inventory (STAI-II)
時間枠：Approximately 5-10 minutes before surgery
|
Trait anxiety will be assessed using the State-Trait Anxiety Inventory-II (STAI-II), which consists of 20 items and measures an individual's general tendency to experience anxiety.
Higher scores indicate higher levels of trait anxiety.
|
Approximately 5-10 minutes before surgery
|
協力者と研究者
スポンサー
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。