Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Ethics Approval No: 2026/062 | Other Identifier | Mersin University Health Sciences Research Ethics Committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| State Anxiety Level (STAI-S) | 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. | At baseline (preoperative day), postoperative day 1, and postoperative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Systolic and diastolic blood pressure will be measured using standard non-invasive monitoring methods. | At baseline (preoperative day), postoperative day 1, and postoperative day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate will be recorded as beats per minute using routine clinical monitoring. | At baseline (preoperative day), postoperative day 1, and postoperative day 2 |
| Respiratory Rate | Respiratory rate will be measured as breaths per minute through routine clinical observation. |
Inclusion Criteria:
Having a planned elective open heart surgery
Exclusion Criteria:
Patients with pre-existing serious psychiatric illnesses (e.g., schizophrenia, bipolar disorder)
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mersin University | Contact | 03242410000 | ebruozdemir@mersin.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Firdevs Ebru Özdemir, PhD | Mersin University | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27087765 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| At baseline (preoperative day), postoperative day 1, and postoperative day 2 |
| Oxygen Saturation (SpO2) | Peripheral oxygen saturation (SpO2) will be measured as a percentage (%) using pulse oximetry as part of routine monitoring. | At baseline (preoperative day), postoperative day 1, and postoperative day 2 |