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NCT Number: NCT07397052

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Nursing Intervention Group

Other

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.

Standard Care Control Group

Other

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 outcomes

  1. 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

  1. Blood Pressure

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

    Systolic and diastolic blood pressure will be measured using standard non-invasive monitoring methods.

Other outcomes

  1. Heart Rate

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

    Heart rate will be recorded as beats per minute using routine clinical monitoring.

  2. Respiratory Rate

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

    Respiratory rate will be measured as breaths per minute through routine clinical observation.

  3. Oxygen Saturation (SpO2)

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

    Peripheral oxygen saturation (SpO2) will be measured as a percentage (%) using pulse oximetry as part of routine monitoring.

Study contacts

Contact information is provided by the study sponsor or research team.

Mersin University

CONTACT

[email protected]

03242410000

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Acronym: OH-MIND

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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