Systematic Review on Pain-Related Outcome Domains After Sternotomy: A First Step Toward the Development of a Core Outcome Set.

OBJECTIVES: Pain after surgery has a major impact on acute and long-term recovery and quality of life, but its management is often insufficient. To enhance the quality of research and to allow for better comparability between studies, it is important to harmonize outcomes for assessing the efficacy and effectiveness of pain management interventions after surgery. As a first step in developing a core outcome set, this study aimed to systematically search for outcome domains assessed in research regarding acute pain management after sternotomy as an example of a typically painful surgical procedure. METHODS: A systematic literature review was performed using MEDLINE, Embase, and CENTRAL. Eligibility criteria consisted of randomized controlled trials and observational trials targeting pain management after sternotomy in adults in the acute postoperative setting (≤2 weeks). After duplicate removal and title and abstract screening by 2 independent reviewers, study characteristics and outcome domains were identified, which were extracted from full texts and summarized qualitatively. RESULTS: Of 1350 studies retrieved by database searching, 156 studies were included for full-text extraction. A total of 80 different outcome domains were identified: pain intensity, analgesic consumption, physiological function, and adverse events were the most frequent ones. Outcome domains were often not explicitly reported, and the combination of domains and assessment tools was heterogeneous. The choice of outcomes is commonly made within clinicians; patients' perspectives are not considered. CONCLUSIONS: The wide variety of commonly applied outcome domains, the nonexplicit wording, and the heterogeneous combination of the domains indicating treatment benefit demonstrate the need for harmonization of outcomes assessing perioperative pain management after surgery.

The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial.

OBJECTIVE: To report the first randomized controlled trial to investigate if immersive virtual reality (VR) treatment can reduce patient perceptions of anxiety compared with a tablet-based control treatment in adults undergoing a first-time sternotomy. METHODS: Twenty first-time sternotomy patients were prospectively randomized (blinded to investigator) to a control or VR intervention. The VR intervention was a game module "Bear Blast" (AppliedVR) displayed using a Samsung Gear Oculus VR headset. The control intervention was a tablet-based game with comparable audio, visual, and tactile components. The State-Trait Anxiety Inventory was administered before and after the assigned intervention. Self-reported anxiety measures between the control and VR groups were evaluated using an unpaired t test. Changes in self-reported anxiety measures pre- and post-intervention were evaluated with a paired t test for both the control and VR groups. The study took place from May 1, 2017, through January 1, 2019 (Institutional Review Board 16-009784). RESULTS: Both control and VR groups were 90.0% male, with a mean ± SD age of 63.4 ± 9.11 and 69.5 ± 6.9 years, respectively. VR users experienced significant reductions in feeling tense and strained, and significant improvements in feeling calm when compared with tablet controls (P<0.05). They also experienced significant reductions in feeling strained, upset, and tense when compared with their own self-reported anxiety measure pre- and post-intervention (P<0.05). Critically, control patients had no change in these categories. CONCLUSION: Immersive VR is an effective, nonpharmacologic approach to reducing preoperative anxiety in adults undergoing cardiac surgery and shows the validity and utility of this technology in adult patients.