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

Official title

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

Overview

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.

Interventions

• 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
• 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.

Primary outcome measures

• State Anxiety Level (STAI-S) [Time frame: At baseline (preoperative day), postoperative day 1, and postoperative day 2]

Secondary outcome measures (1)

• Blood Pressure [Time frame: At baseline (preoperative day), postoperative day 1, and postoperative day 2]

Eligibility criteria

Inclusion criteria

• Having a planned elective open heart surgery

• Being able to communicate in Turkish and understand the given instructions
• Being conscious, cooperative and oriented
• Having agreed to participate in the research in the preoperative period
• Being extubated and hemodynamically stable in the postoperative period

Exclusion criteria

• Patients with pre-existing serious psychiatric illnesses (e.g., schizophrenia, bipolar disorder)

• Patients with cognitive impairment or those unable to complete the STAI-S scale
• Patients with neurological or sensory problems that impair hearing, speech, or communication
• Patients requiring long-term mechanical ventilation in the postoperative period
• Patients requiring re-intubation in the postoperative period
• Patients with hemodynamic instability or those monitored under deep sedation in the intensive care unit
• Patients who develop serious postoperative complications (e.g., stroke, massive bleeding)
• Patients who refuse to participate in the study or wish to withdraw from the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Garland EL, Farb NA, Goldin P, Fredrickson BL. Mindfulness Broadens Awareness and Builds Eudaimonic Meaning: A Process Model of Mindful Positive Emotion Regulation. Psychol Inq. 2015 Oct 1;26(4):293-314. doi: 10.1080/1047840X.2015.1064294. Epub 2015 Nov 24. PMID 27087765

Identifiers

NCT: NCT07397052 · OPENHEART-MINDFULNESS-2026 · Ethics Approval No: 2026/062

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗