Ziehm Susanne, Rosendahl Jenny, Barth Jürgen, Strauss Bernhard M, Mehnert Anja, Koranyi Susan
Institute of Medical Psychology and Medical Soziology, University Hospital of Leipzig, Philipp-Rosenthal-Straße 55, Leipzig, Saxony, Germany, 4103.
Cochrane Database Syst Rev. 2017 Jul 12;7(7):CD009984. doi: 10.1002/14651858.CD009984.pub3.
This is an update of a Cochrane review previously published in 2014. Acute postoperative pain is one of the most disturbing complaints in open heart surgery, and is associated with a risk of negative consequences. Several trials investigated the effects of psychological interventions to reduce acute postoperative pain and improve the course of physical and psychological recovery of participants undergoing open heart surgery.
To compare the efficacy of psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention control in adults undergoing open heart surgery for pain, pain medication, psychological distress, mobility, and time to extubation.
For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Web of Science, and PsycINFO for eligible studies up to February 2017. We used the 'related articles' and 'cited by' options of eligible studies to identify additional relevant studies. We checked lists of references of relevant articles and previous reviews. We searched the ProQuest Dissertations and Theses Full Text Database, ClinicalTrials and the WHO International Clinical Trials Registry Platform to identify any unpublished material or ongoing trials. We also contacted the authors of primary studies to identify any unpublished material. In addition, we wrote to all leading heart centres in Germany, Switzerland, and Austria to check whether they were aware of any ongoing trials.
Randomised controlled trials comparing psychological interventions as an adjunct to standard care versus standard care alone or standard care plus attention in adults undergoing open heart surgery.
Two review authors (SZ and SK) independently assessed trials for eligibility, estimated the risk of bias and extracted all data. We calculated effect sizes for each comparison (Hedges' g) and meta-analysed data using a random-effects model. We assessed the evidence using GRADE and created 'Summary of findings' tables.
We added six studies to this update. Overall, we included 23 studies (2669 participants).For the majority of outcomes (two-thirds), we could not perform a meta-analysis since outcomes were not measured, or data were provided by one trial only.No study reported data on the number of participants with pain intensity reduction of at least 50% from baseline. Only one study reported data on the number of participants below 30/100 mm on the Visual Analogue Scale (VAS) in pain intensity (very low-quality evidence). Psychological interventions did not reduce pain intensity in the short-term interval (g 0.39, 95% CI -0.18 to 0.96, 2 studies, 104 participants, low-quality evidence), medium-term interval (g -0.02, 95% CI -0.24 to 0.20, 4 studies, 413 participants, moderate-quality evidence) or in the long-term interval (g 0.05, 95% CI -0.20 to 0.30, 2 studies, 200 participants, moderate-quality evidence).No study reported data on median time to re-medication or on number of participants re-medicated. Only two studies provided data on postoperative analgesic use in the short-term interval, showing that psychological interventions did not reduce the use of analgesic medication (g 1.18, 95% CI -2.03 to 4.39, 2 studies, 104 participants, low-quality evidence). Studies revealed that psychological interventions reduced mental distress in the medium-term (g 0.37, 95% CI 0.13 to 0.60, 13 studies, 1388 participants, moderate-quality evidence) and likewise in the long-term interval (g 0.32, 95% CI 0.10 to 0.53, 14 studies, 1586 participants, moderate-quality evidence). Psychological interventions did not improve mobility in the medium-term interval (g 0.23, 95% CI -0.22 to 0.67, 3 studies, 444 participants, low-quality evidence), nor in the long-term interval (g 0.09, 95% CI -0.10 to 0.28, 4 studies, 458 participants, moderate-quality evidence). Only two studies reported data on time to extubation, indicating that psychological interventions reduced the time to extubation (g 0.56, 95% CI 0.08 to 1.03, 2 studies, 154 participants, low-quality evidence).Overall, the very low to moderate quality of the body of evidence on the efficacy of psychological interventions for acute pain after open heart surgery cannot be regarded as sufficient to draw robust conclusions.Most 'Risk of bias' assessments were low or unclear. We judged selection bias (random sequence generation) and attrition bias to be mostly low risk for included studies. However, we judged the risk of selection bias (allocation concealment), performance bias, detection bias and reporting bias to be mostly unclear.
AUTHORS' CONCLUSIONS: In line with the conclusions of our previous review, there is a lack of evidence to support or refute psychological interventions in order to reduce postoperative pain in participants undergoing open heart surgery. We found moderate-quality evidence that psychological interventions reduced mental distress in participants undergoing open heart surgery. Given the small numbers of studies, it is not possible to draw robust conclusions on the efficacy of psychological interventions on outcomes such as analgesic use, mobility, and time to extubation respectively on adverse events or harms of psychological interventions.
这是对2014年发表的一篇Cochrane系统评价的更新。急性术后疼痛是心脏直视手术中最令人困扰的主诉之一，且与不良后果风险相关。多项试验研究了心理干预对减轻心脏直视手术患者急性术后疼痛及改善其身心恢复进程的效果。
比较心理干预作为标准护理辅助措施与单纯标准护理或标准护理加注意力控制措施，在接受心脏直视手术的成人患者中对疼痛、止痛药物使用、心理困扰、活动能力及拔管时间的疗效。
对于本次更新，我们检索了Cochrane对照试验中心注册库（CENTRAL）、MEDLINE、Embase、科学引文索引（Web of Science）和心理学文摘数据库（PsycINFO），以查找截至2017年2月的符合条件的研究。我们利用符合条件研究的“相关文章”和“被引用文献”选项来识别其他相关研究。我们检查了相关文章和既往综述的参考文献列表。我们检索了ProQuest学位论文全文数据库、临床试验数据库以及世界卫生组织国际临床试验注册平台，以识别任何未发表的资料或正在进行的试验。我们还联系了主要研究的作者以识别任何未发表的资料。此外，我们致函德国、瑞士和奥地利的所有主要心脏中心，询问他们是否知晓任何正在进行的试验。
随机对照试验，比较心理干预作为标准护理辅助措施与单纯标准护理或标准护理加注意力控制措施，在接受心脏直视手术的成人患者中的效果。
两位综述作者（SZ和SK）独立评估试验的纳入资格、估计偏倚风险并提取所有数据。我们计算了每个比较的效应量（Hedges' g），并使用随机效应模型对数据进行荟萃分析。我们使用GRADE评估证据，并创建“结果总结”表。
本次更新中我们新增了6项研究。总体而言，我们纳入了23项研究（2669名参与者）。对于大多数结局（三分之二），我们无法进行荟萃分析，因为结局未被测量，或仅有一项试验提供了数据。没有研究报告疼痛强度从基线降低至少50%的参与者数量的数据。仅有一项研究报告了疼痛强度视觉模拟量表（VAS）评分低于30/100mm的参与者数量的数据（极低质量证据）。心理干预在短期（g = 0.39，95%CI -0.18至0.96，2项研究，104名参与者，低质量证据）、中期（g = -0.02，95%CI -0.24至0.20，4项研究，413名参与者，中等质量证据）或长期（g = 0.05，95%CI -0.20至0.30，2项研究，200名参与者，中等质量证据）均未降低疼痛强度。没有研究报告再次用药的中位时间或再次用药参与者数量的数据。仅有两项研究提供了短期术后镇痛药物使用的数据，表明心理干预未减少镇痛药物的使用（g = 1.18, 95%CI -2.03至4.39, 2项研究, 104名参与者, 低质量证据）。研究表明，心理干预在中期（g = 0.37，95%CI 0.13至0.60，13项研究，1388名参与者，中等质量证据）和长期（g = 0.32，95%CI 0.10至0.53，14项研究，1586名参与者，中等质量证据）均降低了心理困扰。心理干预在中期（g = 0.23，95%CI -0.22至0.67，3项研究，444名参与者，低质量证据）和长期（g = 0.09，95%CI -0.10至0.28，4项研究，458名参与者，中等质量证据）均未改善活动能力。仅有两项研究报告了拔管时间的数据，表明心理干预缩短了拔管时间（g = 0.56，95%CI 0.08至1.03，2项研究，154名参与者，低质量证据）。总体而言，关于心理干预对心脏直视手术后急性疼痛疗效的证据质量极低至中等，不足以得出有力结论。大多数“偏倚风险”评估为低或不明确。我们判断纳入研究的选择偏倚（随机序列生成）和失访偏倚大多为低风险。然而，我们判断选择偏倚（分配隐藏）、实施偏倚、检测偏倚和报告偏倚大多不明确。
与我们之前综述的结论一致，缺乏证据支持或反驳心理干预可减轻心脏直视手术患者术后疼痛这一观点。我们发现中等质量证据表明心理干预可减轻心脏直视手术患者的心理困扰。鉴于研究数量较少，无法就心理干预对诸如镇痛药物使用、活动能力和拔管时间等结局的疗效，或心理干预的不良事件或危害得出有力结论。
