NCT07397052

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

January 29, 2026

Last Update Submit

February 5, 2026

Conditions

Open Heart SurgeryAnxiety

Keywords

MindfulnessAnxietyVital SignsNursing Care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Blood Pressure

    At baseline (preoperative day), postoperative day 1, and postoperative day 2

Other Outcomes (3)

  • Heart Rate

    At baseline (preoperative day), postoperative day 1, and postoperative day 2

  • Respiratory Rate

    At baseline (preoperative day), postoperative day 1, and postoperative day 2

  • Oxygen Saturation (SpO2)

    At baseline (preoperative day), postoperative day 1, and postoperative day 2

Study Arms (2)

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.

Other: Standard Care Control 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.

Other: Mindfulness-Based Nursing Intervention Group

Interventions

Mindfulness-Based Nursing Intervention GroupOTHER

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.

Mindfulness-Based Nursing Intervention Group
Standard Care Control GroupOTHER

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.

Standard Care Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 27087765BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Firdevs Ebru Ă–zdemir, PhD

    Mersin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mersin University

CONTACT

03242410000ebruozdemir@mersin.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 9, 2026

Study Start

February 10, 2026

Primary Completion

April 20, 2026

Study Completion

May 20, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02