Effect of Virtual Reality During Femoral Sheath Removal
The Effect of Virtual Reality Glasses During Femoral Sheath Removal on Pain, Anxiety, and Vital Signs in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Controlled Trial
調査の概要
詳細な説明
Percutaneous coronary intervention is a commonly used invasive procedure in the diagnosis and treatment of coronary artery disease. Femoral sheath removal performed after the procedure may cause pain, anxiety, and hemodynamic changes in patients. Non-pharmacological interventions are increasingly used to improve patient comfort and reduce procedure-related stress.
Virtual reality technology is considered an effective distraction method that may reduce pain perception and anxiety by directing patients' attention to immersive visual and auditory stimuli. Previous studies have demonstrated the positive effects of virtual reality applications during invasive and painful procedures.
This randomized controlled study aimed to investigate the effect of virtual reality glasses used during femoral sheath removal on pain, anxiety, and vital signs in patients undergoing percutaneous coronary intervention. Patients were randomly assigned to either the intervention group receiving virtual reality application during femoral sheath removal or the control group receiving standard care. Pain intensity, anxiety levels, and vital signs were evaluated before, during, and after the procedure.
The findings of this study may contribute to evidence-based nursing interventions aimed at improving patient comfort during femoral sheath removal procedures.
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
-
-
Hatay
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İskenderun、Hatay、トルコ（Türkiye）
- İskenderun Devlet Hastanesi
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-
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
Inclusion Criteria:
- Patients aged 18 years and older
- Patients undergoing percutaneous coronary intervention via femoral access
- Patients with only one femoral sheath catheter
- Patients who did not receive analgesic medication before sheath removal
- Patients without severe hemorrhage or major hematoma at the femoral sheath site
- Patients able to communicate in Turkish
- Patients without visual, hearing, or speech impairment
- Patients without mental impairment affecting communication
- Patients without psychiatric diagnosis and not using psychiatric medication
Exclusion Criteria:
Patients unwilling to participate or wishing to withdraw from the study at any stage
- Patients who removed the virtual reality glasses during the intervention
- Patients who experienced intolerance to virtual reality application (e.g., dizziness or nausea)
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Virtual Reality Group
Participants received virtual reality glasses during femoral sheath removal
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Virtual reality glasses were used during femoral sheath removal.
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|
他の：Control Group
Participants received routine care during femoral sheath removal
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Participants received routine care during femoral sheath removal
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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 |
|---|---|---|
|
Heart Rate
時間枠：Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
|
Heart rate was measured in beats per minute using routine monitoring.
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Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
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|
Blood Pressure
時間枠：Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
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Systolic blood pressure and diastolic blood pressure were measured in mmHg using routine monitoring.
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Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
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Oxygen Saturation
時間枠：Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
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Oxygen saturation was measured as percent saturation using pulse oximetry.
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Periprocedural (5 minutes before sheath removal, 5 and 15 minutes after sheath removal)
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|
Body Temperature
時間枠：5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
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Body temperature was assessed using routine vital sign monitoring.
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5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
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Pain Level
時間枠：5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
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Pain level was assessed using the Numeric Rating Scale (NRS).
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates severe pain.
Higher scores indicate greater pain severity.
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5 minutes before femoral sheath removal, 5 minutes after femoral sheath removal, and 15 minutes after femoral sheath removal
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Anxiety Level
時間枠：Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
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Anxiety level was assessed using the State Anxiety Inventory (STAI).
Higher scores indicate higher anxiety levels.
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Before femoral sheath removal during completion of the participant information form, and 15 minutes after femoral sheath removal
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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
本研究に関する用語
キーワード
その他の研究ID番号
- HKU-2025/069
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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
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。
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