Impact of Anxiety and Sleep Disturbances on Postoperative Outcomes in Male Cardiothoracic Surgery Patients: A Multicenter Randomized Controlled Trial Evaluating a Psychological Intervention During the ICU Phase

Yue Zhang¹Xiamglong Kong^2*Jing Shi^3*Dan Li¹Xiaofei Bi³Xu Fang¹Yang Jing¹Baicheng Zhang²

• ¹Second Affiliated Hospital of Harbin Medical University, Harbin, China
• ²Third Affiliated Hospital of Harbin Medical University, Harbin, China
• ³Sixth Affiliated Hospital of Harbin Medical University, Harbin, China

To investigate the prevalence and impact of anxiety and sleep disturbances during the intensive care unit (ICU) stay following cardiothoracic surgery in male patients, and to evaluate the efficacy and feasibility of a structured psychological intervention combining Cognitive Behavioral Therapy for Insomnia (CBT-I) principles with environmental optimization.This study was designed as a multicenter, prospective, randomized controlled trial (RCT) conducted from January to April 2025 across three tertiary hospitals. A total of 120 adult male patients who underwent radical surgery for cardiac or lung cancer and were subsequently admitted to the ICU were enrolled. Baseline assessments were performed within 48 hours after surgery. Participants were randomly allocated in a 1:1 ratio to either the intervention group (n = 60) or the standard care group (n = 60) using a computer-generated randomization sequence with concealed allocation. While the standard care group received routine perioperative management, the intervention group additionally received a structured psychological intervention that incorporated components of Cognitive Behavioral Therapy for Insomnia (CBT-I) -including sleep education, relaxation training, and behavioral strategies -along with daily psychological support and environmental optimization measures such as noise reduction, lighting adjustment, and use of sleep-promoting devices. Primary outcomes included Generalized Anxiety Disorder-7 (GAD-7), Pittsburgh Sleep Quality Index (PSQI), Numeric Rating Scale (NRS) for pain, ICU length of stay, incidence of postoperative complications, and the 30-day postoperative quality of life as measured by the SF-36. Multivariate logistic regression was used to assess the predictive value of anxiety and sleep disturbances on postoperative outcomes.On postoperative day 3, the intervention group showed significantly lower GAD-7 scores (6.3 ± 1.6 vs 8.4 ± 2.3, p = 0.016) and PSQI scores (7.5 ± 1.6 vs 10.2 ± 2.3, p < 0.01) compared to the standard care group. Pain scores were also significantly reduced (2.7 ± 1.2 vs 3.6 ± 1.3, p = 0.018). Early implementation of a CBT-I -based psychological intervention in the ICU can effectively improve psychological status, shorten ICU stays, and reduce postoperative complications. The intervention is safe and shows high clinical utility, warranting consideration for integration into standardized postoperative care pathways, particularly in high-risk male populations.