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.

OBJECTIVE

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.

METHODS

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 h after surgery. Participants were randomly allocated in a 1:1 ratio to either the intervention group ( = 60) or the standard care group ( = 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.

RESULTS

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, < 0.01) compared to the standard care group. Pain scores were also significantly reduced (2.7 ± 1.2 vs. 3.6 ± 1.3, = 0.018). The intervention group had a shorter ICU stay (2.5 ± 0.6 days vs. 3.7 ± 1.2 days, < 0.01), a lower rate of postoperative complications (17% vs. 36%, = 0.033), and significantly better SF-36 scores at 30 days post-surgery ( < 0.05). Multivariate logistic regression identified both anxiety and sleep disturbance as independent predictors of postoperative complications (GAD-7: OR = 1.25, 95% CI: 1.03-1.42; PSQI: OR = 1.33, 95% CI: 1.14-1.51).

CONCLUSION

Anxiety and sleep disturbances are common during the postoperative ICU phase in male patients undergoing cardiothoracic surgery and are significantly associated with pain, complications, and recovery outcomes. 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.

CLINICAL TRIAL REGISTRATION

The study was retrospectively registered on the Chinese Clinical Trial Registry (ChiCTR) under the identifier ChiCTR240000123.