The Effect of Virtual Reality Goggles on Pain, Anxiety and Sleep in Patients Undergoing Total Knee Arthroplasty
It Was Planned as a Single-blind Randomized Controlled Study to Determine the Effect of Virtual Reality Goggles on Pain, Anxiety and Sleep in Patients Undergoing Total Knee Arthroplasty.
Knee osteoarthritis, which occurs after degeneration of the knee joint with age, is common in women after 65 years of age and surgical methods are generally used in the treatment of deformity, pain and limitation of movement. This surgical procedure is different from other surgical procedures.
It takes a long time to perform activities of daily living and return to quality life. At the same time, pain, anxiety and sleep disorders are among the most common problems in the postoperative period. In addition to pharmacological methods, non-pharmacological methods (listening to music, watching movies, daydreaming, humor, virtual reality application, laughter) are used to reduce these problems. In recent years, especially virtual reality application has started to be used as a distraction-based approach in recent years. Virtual reality is the artificial creation of a three-dimensional environment through computer technology. In this application, it is ensured that the individual feels that he/she is a part of the created virtual environment with immersive environments that seem effective. This study was planned to determine the effect of virtual reality glasses on pain, anxiety and sleep in patients undergoing total knee arthroplasty. The study will be conducted with participants who are willing to participate in the study and whose consent has been obtained.
One group will receive virtual reality goggles (experiment) and the other group will receive standard care.
Control group
They will be asked to evaluate their level of "Anxiety and Pain" before and two days after Total Knee Arthroplasty surgery and their level of Sleep at their convenience after waking up the next day.
Experimental group
In addition to the standard care and practices applied to the participants in the control group, you will be asked to watch videos of relaxing nature scenes wearing "Virtual Reality Goggles". These videos last 30 minutes. You will be asked to fill in the same scales for two days preoperatively and two days postoperatively as the participants in the control group.
調査の概要
詳細な説明
For Patient Registries: Also describe the applicable registry procedures and other quality factors (for example, third party certification, on-site audit). In particular, summarize any procedures implemented as part of the patient registry, including, but not limited to the following:
Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.
Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (for example, medical records, paper or electronic case report forms, or interactive voice response systems).
Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used (for example, World Health Organization Drug Dictionary, MedDRA), and normal ranges if relevant.
Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results.
Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and
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
-
-
Zeytinburnu
-
Istanbul、Zeytinburnu、トルコ（Türkiye）、34010
- Istinye University
-
-
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 undergoing elective primary total knee arthroplasty due to knee osteoarthritis
- Patients able to communicate in Turkish
- Patients mobilized on the first postoperative day according to the hospital's standard postoperative care protocol
- Patients with a postoperative pain score ≥4 on the Numerical Rating Scale
- Patients providing written informed consent
Exclusion Criteria:
- Patients experiencing postoperative complications (e.g., severe bleeding, persistent nausea or vomiting),
- Cognitive or sensory impairment,
- Psychiatric disorders, communication difficulties, history of dizziness, uncontrolled hypertension, or patients using sedative or anxiolytic drugs were excluded from the study.
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：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 standard postoperative care plus a nurse-guided virtual reality intervention.
|
Participants received standard postoperative care plus a nurse-guided virtual reality intervention.
|
|
介入なし：Control Group
Participants received standard postoperative care according to the orthopaedic clinic protocol.
|
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 |
|---|---|---|
|
Postoperative pain intensity measured by the Numeric Rating Scale (NRS)
時間枠：Immediately before and immediately after each VR session on postoperative day 1 and postoperative day 2
|
Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), with higher scores indicating greater pain.
|
Immediately before and immediately after each VR session on postoperative day 1 and postoperative day 2
|
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
本研究に関する用語
その他の研究ID番号
- No sponsor support
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?
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。