Effect of Virtual Reality on Pain, Anxiety and Vital Signs During Diabetic Foot Care
2026年5月7日 更新者：Yasemin Özkul、Malatya Turgut Ozal University
The Effect of Virtual Reality Intervention on Pain Level, State Anxiety, and Vital Signs During Foot Care in Individuals With Diabetic Foot Ulcers
This study aims to determine the effects of a virtual reality (VR) intervention on pain level, state anxiety, and vital signs during foot care in individuals with diabetic foot ulcers.
The study was designed as a randomized controlled trial and includes 64 individuals with diabetes (intervention=32, control=32).
The intervention group will receive VR during diabetic foot care, while the control group will receive standard care.
Data will be collected at pre-test and post-test using the Demographic Information Form, Vital Signs Form, State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) for pain.
Data analysis will be performed using SPSS 22.0.
調査の概要
研究の種類
介入
入学 (実際)
64
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Malatya
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Malatya、Malatya、トルコ（Türkiye）、4400
- Malatya Turgut Özal University Training and Research Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Age 18 years and older Diagnosis of Type 2 Diabetes Mellitus Diabetic foot ulcer classified as Wagner stage 3 or 4 No mental or physical condition that would interfere with communication or participation No visual or hearing impairment Ability to understand and speak Turkish Willingness to participate in the study
Exclusion Criteria:
- Presence of chronic wounds other than diabetic foot ulcer (e.g., arterial or venous ulcers) Age under 18 years
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
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実験的：Intervention Group (VR Group)
Participants received virtual reality (VR) intervention during diabetic foot care procedures in addition to standard care.
VR was used as a non-pharmacological distraction method during the procedure.
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Participants in the intervention group received virtual reality (VR) exposure during diabetic foot care procedures.
A virtual reality headset was used as a non-pharmacological distraction method to reduce pain and anxiety.
The VR intervention was applied during the procedure in addition to standard diabetic foot care.
Vital signs such as blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure to evaluate physiological responses.
他の名前：
Participants in the control group received standard diabetic foot care according to institutional protocols, without any virtual reality intervention.
Vital signs including blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure.
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アクティブコンパレータ：Control Group
Participants received standard diabetic foot care without virtual reality intervention.
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Participants in the control group received standard diabetic foot care according to institutional protocols, without any virtual reality intervention.
Vital signs including blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature were monitored before and after the procedure.
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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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Change in Pain Level
時間枠：Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Pain intensity measured using the Visual Analog Scale (VAS), a 10 cm horizontal line anchored at 0 (no pain) and 10 (worst imaginable pain).
Higher scores indicate greater pain.
Change is calculated as post-test score minus pre-test score.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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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 |
|---|---|---|
|
Change in State Anxiety
時間枠：Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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State anxiety measured using the State subscale of the State-Trait Anxiety Inventory (STAI-I), a validated 20-item self-report scale scored 20-80.
Higher scores indicate greater anxiety.
Change is calculated as post-test score minus pre-test score.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Body Temperature
時間枠：Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Body temperature (°C) measured using a non-contact infrared thermometer (Life Net Medical JA-11C).
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Oxygen Saturation (SpO₂)
時間枠：Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Peripheral oxygen saturation (SpO₂, %) measured using a fingertip pulse oximeter (Life Net Medical PFX033).
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Pulse Rate
時間枠：Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Pulse rate (beats per minute) measured using a fingertip pulse oximeter (Life Net Medical PFX033).
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
|
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Change in Respiratory Rate
時間枠：Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Respiratory rate (breaths per minute) assessed by direct observation and counting by the researcher.
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Systolic Blood Pressure
時間枠：Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Systolic blood pressure (mmHg) measured using an upper-arm automated sphygmomanometer (Omron M3 Comfort HEM-7155-E) after the participant had been seated and resting for at least 5 minutes.
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Change in Diastolic Blood Pressure
時間枠：Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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Diastolic blood pressure (mmHg) measured using an upper-arm automated sphygmomanometer (Omron M3 Comfort HEM-7155-E) after the participant had been seated and resting for at least 5 minutes.
Change is calculated as post-test value minus pre-test value.
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Pre-test: approximately 5 minutes before foot care; Post-test: within 0-2 minutes after completion of foot care
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年12月9日
一次修了 (実際)
2025年6月15日
研究の完了 (実際)
2025年6月15日
試験登録日
最初に提出
2026年4月30日
QC基準を満たした最初の提出物
2026年5月7日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月14日
QC基準を満たした最後の更新が送信されました
2026年5月7日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- E-30785963-020-266758
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?
いいえ
IPD プランの説明
Individual participant data (IPD) will not be shared due to patient privacy and confidentiality concerns.
The data are collected within a single institutional clinical study for academic thesis purposes and are not planned for public data sharing.
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いいえ
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