NCT07397052

Mindfulness-Based Nursing Care and Anxiety in Open Heart Surgery Patients

The Effect of Mindfulness-Based Nursing Intervention on Anxiety and Vital Signs in Patients Undergoing Open Heart Surgery: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Mersin University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled trial aims to evaluate the effect of a mindfulness-based nursing intervention on anxiety levels and vital signs in patients undergoing open-heart surgery during the preoperative and early postoperative periods.

Detailed description

Patients undergoing open-heart surgery may experience high levels of anxiety due to the complexity of the surgical procedure, the intensive care environment, pain, invasive interventions, and the perception of a life-threatening condition. Increased perioperative anxiety has been reported to negatively affect vital signs such as blood pressure, heart rate, and respiratory rate, prolong recovery, and reduce patient comfort. Although pharmacological methods are commonly used to manage anxiety, they may cause adverse effects including sedation, respiratory depression, and hemodynamic instability. Therefore, non-pharmacological nursing interventions are of particular importance in cardiac surgery patients. Psychosocial and supportive nursing interventions have been shown to reduce anxiety and support physiological stability. In recent years, mindfulness-based interventions have emerged as safe and feasible approaches to reduce stress and anxiety through breath awareness, relaxation, and present-moment techniques. Previous studies in various surgical populations have demonstrated that mindfulness-based interventions can reduce anxiety levels and positively influence certain physiological parameters. However, randomized controlled trials evaluating structured and short-term mindfulness-based nursing interventions during the preoperative and early postoperative periods in open-heart surgery patients are limited. This study is designed as a quantitative, randomized controlled trial to evaluate the effects of mindfulness-based nursing interventions applied during the preoperative and early postoperative periods on anxiety levels and vital signs in patients undergoing open-heart surgery. The findings are expected to contribute to evidence-based nursing practices and support clinical care processes in the management of anxiety in cardiac surgery patients. The mindfulness-based nursing intervention consists of brief, structured sessions focusing on breath awareness, relaxation, and present-moment attention, delivered individually by a trained nurse during the preoperative and early postoperative periods. Outcome assessments, including anxiety questionnaires and vital sign measurements, will be performed by nurses who are not involved in the intervention and are blinded to group allocation.

Conditions

• Open Heart Surgery
• Anxiety

Interventions

Type	Name	Description
OTHER	Mindfulness-Based Nursing Intervention Group	The mindfulness-based nursing intervention consists of three structured individual sessions delivered by a trained nurse. The first session is conducted one day before surgery, and the second and third sessions are conducted on postoperative day 1 and postoperative day 2, respectively, after extubation when the patient is cooperative and hemodynamically stable. Each session lasts approximately 15-20 minutes and includes guided breathing awareness, relaxation techniques, and brief body awareness exercises adapted to the perioperative cardiac surgery setting. The intervention focuses on present-moment awareness, non-judgmental attention to bodily sensations, and calming of anxiety-related thoughts. All sessions are delivered individually at the patient's bedside in a quiet environment. No prior mindfulness experience is required. The intervention is standardized and applied consistently to all participants in the intervention group.
OTHER	Standard Care Control Group	Participants in the control group will receive standard perioperative nursing care routinely provided in the cardiovascular surgery clinic. This includes routine preoperative preparation, postoperative monitoring, pain management, and nursing care according to institutional protocols. No additional mindfulness, relaxation, or psycho-educational intervention will be provided.

Timeline

• Start date: 2026-02-10
• Primary completion: 2026-04-20
• Completion: 2026-05-20
• First posted: 2026-02-09
• Last updated: 2026-02-09