Effects of biophilic virtual reality on cognitive function of patients undergoing laparoscopic surgery: study protocol for a sham randomised controlled trial.
Effects of biophilic virtual reality on cognitive function of patients undergoing laparoscopic surgery: study protocol for a sham randomised controlled trial.
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DOI：
10.1136/bmjopen-2021-052769
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发表时间：
2022-07-08
期刊：
影响因子：
2.9
通讯作者：
Wang, Jianhua
中科院分区：
文献类型：
--
作者：
Zhu, Binbin;Zhou, Yanling;Weng, Qiuyan;Luo, Wenjun;He, Xiuchao;Jin, Lufei;Wang, Qinwen;Gao, Bin;Harb, Ahmad Khaled Ahmad;Wang, Jianhua
虚拟现实（VR）已被用于认知或情感康复。然而，其在术后认知功能障碍（POCD）中的作用尚未得到充分认识。由于缺乏有效的术后随访系统，中国POCD的发病率尚不明确，并且尽管在动物研究中提出了许多改善POCD的药物，但它们的临床应用有限，而VR提供了一种创新的非药物管理方法。
这是一项单中心、随机、双盲、假对照临床试验。在本研究中，将招募600名55岁以上接受腹腔镜手术的患者。参与者将被随机分配接受亲生物VR或假VR（1∶1比例），所有患者在住院期间每天接受20分钟的干预。主要结局是VR对POCD发病率的影响。次要结局包括围手术期焦虑和工具性日常生活活动能力。由当地住院医师测量神经认知测试组合的表现变化。将在手术前一天和手术后7天采集血清样本。
本试验已获得宁波大学医学院附属医院医学伦理委员会的伦理批准（KY20210302）。本研究由宁波大学和宁波市科技局资助。联系人：医院医学伦理委员会主席毛海蛟博士（ndfylunli@126.com）。试验结果将提交给同行评审期刊发表，患者招募于2021年4月开始。所有参与者均已获得书面知情同意。所有获取的信息将通过国内或国际会议传播，并在同行评审期刊上发表。
ChiCTR2000040919。
Virtual reality (VR) is already being used for cognitive or emotional rehabilitation. However, its role in postoperative cognitive dysfunction (POCD) has not been fully recognised. Due to the lack of an effective postoperative follow-up system, the incidence of POCD in China is not clear, and although many drugs have been proposed to improve POCD in the animal study, their clinical applications are limited, while VR provides an innovative method to provide non-pharmacological management. This is a single-centre, randomised, double-blind, sham-controlled clinical trial. In this study, 600 patients over 55 years old undergoing laparoscopic surgery will be recruited. Participants will be randomly assigned to receive biophilic VR or sham VR (1:1 ratio), all patients have 20 min of exposure per day during the hospital stay. The primary outcome is the impact of VR on the incidence of POCD. Secondary outcomes include perioperative anxiety and instrumental activities of daily living. Changes in the performance of the neurocognitive batteries are measured by a local resident doctor. Serum samples will be collected on the day before surgery and 7 days after surgery. This trial has ethical approval from the Medical Ethics Committee of the Affiliated Hospital of Medical School of Ningbo University (KY20210302). The study is sponsored by Ningbo University and Ningbo Science and Technology Bureau. Contact: Dr. Mao Haijiao, Chair of the hospital medical Ethics committee (ndfylunli@126.com). Trial results will be submitted for publication in peer-reviewed journals, patient recruitment began in April 2021. Written informed consent is obtained for all participants. All information acquired will be disseminated via national or international conferences and published in peer-reviewed journals. ChiCTR2000040919.
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影响因子：
1.6
作者：
Hu, Jian;Li, Chun-Jing;Wang, Dong-Xin
通讯作者：
Wang, Dong-Xin
影响因子：
3.5
作者：
Wahlin, Anders;Fordell, Helena;Malm, Jan
通讯作者：
Malm, Jan
DOI：
10.1126/science.aaw2622
发表时间：
2020-07-10
期刊：
Science (New York, N.Y.)
影响因子：
--
作者：
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通讯作者：
Villeda SA
影响因子：
2.1
作者：
Rudolph JL;Schreiber KA;Culley DJ;McGlinchey RE;Crosby G;Levitsky S;Marcantonio ER
通讯作者：
Marcantonio ER
影响因子：
3
作者：
Prinsloo, Gabriell E.;Derman, Wayne E.;Rauch, H. G. Laurie
通讯作者：
Rauch, H. G. Laurie