Skip to main content
Clinical Trials/NCT07397052
NCT07397052
Not yet recruiting
Not Applicable

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

Mersin University0 sites60 target enrollmentStarted: February 10, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Primary Endpoint
State Anxiety Level (STAI-S)

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Standard Care Control Group

Other

Participants in the control group will receive standard perioperative nursing care routinely provided in the clinic. No additional mindfulness or psycho-educational intervention will be administered. Anxiety levels and vital signs will be assessed at the same time points as in the intervention group.

Intervention: Standard Care Control Group (Other)

Mindfulness-Based Nursing Intervention Group

Experimental

Participants in the intervention group will receive a three-session mindfulness-based nursing intervention delivered individually by a trained nurse. The first session will be conducted one day before surgery, and the second and third sessions will be conducted on postoperative day 1 and postoperative day 2, respectively, after extubation when the patient is cooperative and clinically stable.

Each session will last approximately 15-20 minutes and will include guided breathing awareness, relaxation, and body awareness techniques. All sessions will be conducted individually in the patient's room. The intervention is standardized and applied consistently to all participants in the intervention group.

Intervention: Mindfulness-Based Nursing Intervention Group (Other)

Outcomes

Primary Outcomes

State Anxiety Level (STAI-S)

Time Frame: At baseline (preoperative day), postoperative day 1, and postoperative day 2

Anxiety level will be assessed using the State Anxiety subscale of the State-Trait Anxiety Inventory (STAI-S), a validated self-report scale consisting of 20 items. Total scores range from 20 to 80, with higher scores indicating higher levels of anxiety.

Secondary Outcomes

  • Blood Pressure(At baseline (preoperative day), postoperative day 1, and postoperative day 2)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

FİRDEVS EBRU ÖZDEMİR

PhD

Mersin University

Similar Trials