The FEEDBACK Trial, a Randomized Controlled Trial (Feedback)
Impact of Instructor Feedback on Performance in a Virtual Reality Simulator: A Randomized, Controlled Trial
With a worldwide proliferation of simulation centers, it is essential to explore the optimal setting for laparoscopic training and investigate different learning approaches, e.g. a self-directed approach. Therefore, the researchers investigated the following in a randomized controlled trial: the impact of instructor feedback vs. an independent, self-directed approach when training a complex operational task on a laparoscopic virtual reality simulator.
The study hypothesis is that instructor feedback has a pivotal effect on surgical skills when training on a virtual reality simulator.
調査の概要
詳細な説明
For virtual reality (VR) simulation the benefits are clear; the drawbacks are less clear. Throughout the last decade several studies have found a positive effect on the learning curve as well as improvement of basic psychomotor skills in the operating room after VR training. VR simulators offer standardized and reproducible laparoscopic tasks, ranging from simple basic skills training to full procedures such as a cholecystectomy or salpingectomy. Despite the now well-established advantages of VR simulators, the majority of surgical and gynecological departments encounter hurdles when implementing this form of training in the surgical education. This is mainly due to lack of knowledge concerning the time and human resources/cost needed to train novice surgeons to an adequate level.
This randomized trial investigates whether instructor feedback is pivotal for the trainee when training operational tasks (a laparoscopic salpingectomy) on a VR simulator. The VR simulator used in this trial is the LapSim from Surgical Science, Sweden. Instructor feedback consists of standardized feedback for ten minutes and with a maximum of three optional feedback sessions; the trainees (in the intervention group) decides them selves when they want a feedback session. The trainees in both the control group and the intervention group have to reach a predefined proficiency level on the VR simulator within 8 weeks with 3-hour training sessions each time. Furthermore, the trial focuses on different learning approaches, e.g. a self-directed approach and an independent approach.
The randomization process will take place at a central unit; Copenhagen Trial Unit, Denmark. Stratification variables are: 1)Gender 2)Computer game experience (less that 20 hours annually)
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
-
-
-
Copenhagen、デンマーク、2100
- Rigshospitalet, University Hospital of Copenhagen
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Medical student at Copenhagen University with passed bachelor degree
- Signed informed consent
Exclusion Criteria:
- Prior experience with surgical virtual reality simulators
- > 3 independent laparoscopic procedures
- Not fluent in the Danish language
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
- 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:Instructor feedback
Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.
|
Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.
|
|
介入なし:No instructor feedback
Control group who did not receive instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.
|
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 |
|---|---|---|
|
Repetitions
時間枠:8 weeks
|
Number of repetitions to complete a predefined proficiency level on a laparoscopic virtual reality simulator
|
8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time
時間枠:8 weeks
|
Time to complete a predefined proficiency level on a laparoscopic virtual reality simulator.
|
8 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Jeanett Oestergaard, MD、Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen Ø, Denmark
出版物と役立つリンク
一般刊行物
- Larsen CR, Soerensen JL, Grantcharov TP, Dalsgaard T, Schouenborg L, Ottosen C, Schroeder TV, Ottesen BS. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial. BMJ. 2009 May 14;338:b1802. doi: 10.1136/bmj.b1802. Erratum In: BMJ. 2009;338. doi: 10.1136/bmj.b2074.
- Larsen CR, Grantcharov T, Aggarwal R, Tully A, Sorensen JL, Dalsgaard T, Ottesen B. Objective assessment of gynecologic laparoscopic skills using the LapSimGyn virtual reality simulator. Surg Endosc. 2006 Sep;20(9):1460-6. doi: 10.1007/s00464-005-0745-x. Epub 2006 Jul 3.
- Bjerrum F, Maagaard M, Led Sorensen J, Rifbjerg Larsen C, Ringsted C, Winkel P, Ottesen B, Strandbygaard J. Effect of instructor feedback on skills retention after laparoscopic simulator training: follow-up of a randomized trial. J Surg Educ. 2015 Jan-Feb;72(1):53-60. doi: 10.1016/j.jsurg.2014.06.013. Epub 2014 Aug 16.
- Strandbygaard J, Bjerrum F, Maagaard M, Winkel P, Larsen CR, Ringsted C, Gluud C, Grantcharov T, Ottesen B, Sorensen JL. Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized trial. Ann Surg. 2013 May;257(5):839-44. doi: 10.1097/SLA.0b013e31827eee6e.
- Oestergaard J, Bjerrum F, Maagaard M, Winkel P, Larsen CR, Ringsted C, Gluud C, Grantcharov T, Ottesen B, Soerensen JL. Instructor feedback versus no instructor feedback on performance in a laparoscopic virtual reality simulator: a randomized educational trial. BMC Med Educ. 2012 Feb 28;12:7. doi: 10.1186/1472-6920-12-7.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (予想される)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
- H-3-2010-082 FEEDBACK
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。