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NCT Number: NCT07471945

Individualized Nursing Care and Frailty Outcomes in Cardiac Surgery

This study is a randomized controlled trial aiming to compare targeted individualized nursing care with standard care in frail elderly patients undergoing cardiac surgery.

The hypotheses of the study are:

H1: Targeted individualized nursing care has an effect on the frailty level of frail elderly patients undergoing cardiac surgery.

H2: Targeted individualized nursing care affects the factors influencing frailty in frail elderly patients undergoing cardiac surgery.

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This study is active but is not currently recruiting participants.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskişehir Osmangazi University Health, Practice, and Research Hospital

Eskişehir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 65 years and older
  • Scheduled for elective surgery
  • Edmonton Frail Scale score ≥ 7
  • Able to speak Turkish and communicate effectively
  • Can be transferred from the postoperative intensive care unit to the ward
  • Patients who agree to participate in the study

Exclusion criteria

  • Patients with neurological or psychological disorders
  • Patients who cannot be transferred from the postoperative intensive care unit to the ward
  • Emergency and unplanned cases

Treatment and study plan

Experimental

Other

Targeted Individualized Nursing Care

Primary outcomes

  1. Cognitive Function - Standardized Mini-Mental State Examination (MMSE)

    Time frame: Postoperative day 1 and the day of discharge

    Cognitive status will be assessed using the Standardized Mini-Mental State Examination (MMSE). The MMSE evaluates orientation, memory, attention, recall, language, and visuospatial skills. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Scores of 23 or below are generally considered indicative of cognitive impairment.

  2. Cognitive Function - Delirium Risk - Nursing Delirium Screening Scale (Nu-DESC)

    Time frame: Postoperative day 1 and the day of discharge

    Delirium risk will be evaluated using the Nursing Delirium Screening Scale (Nu-DESC). The scale assesses five domains: disorientation, inappropriate behavior, inappropriate communication, hallucinations, and psychomotor retardation.

    Each symptom is scored per shift as follows:

    0 points: Symptom absent, 1 point: Symptom present/mild, 2 points: Symptom present and pronounced/severe A total score of 2 points or higher is considered indicative of delirium.

  3. Physical Status Assessment - Pain Level - Numeric Rating Scale (NRS)

    Time frame: Postoperative day 1 and the day of discharge

    Pain Level - Numeric Rating Scale (NRS): Pain intensity will be assessed using the Numeric Rating Scale (NRS). Patients rate their pain from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

  4. Physical Status Assessment - Katz Activities of Daily Living (ADL) Scale

    Time frame: Postoperative day 1 and the day of discharge

    Katz Activities of Daily Living (ADL) Scale: Functional status will be evaluated using the Katz Activities of Daily Living (ADL) Scale, which assesses independence in six activities: bathing, dressing, toileting, transferring, continence, and feeding. Higher scores indicate greater independence in daily activities.

    Evaluation of the scale is based on the total score obtained from these items:

    0-6 points: Dependent, 7-12 points: Partially dependent, 13-18 points: Independent.

  5. Physical Status Assessment - Itaki Fall Risk Scale

    Time frame: Postoperative day 1 and the day of discharge

    Itaki Fall Risk Scale: The Itaki Fall Risk Scale will be used to evaluate patients' risk of falling. The scale assesses various risk factors related to falls in hospitalized patients. The scale consists of 19 risk factors that may contribute to patient falls. The risk factors are categorized as major and minor, with 1 point assigned for each minor risk factor and 5 points for each major risk factor. Based on the total score obtained from evaluating all risk factors, two risk levels are defined: 0-4 points: Low risk, 5 points and above: High risk.

  6. Nutritional Status - Mini Nutritional Assessment Short Form (MNA-SF)

    Time frame: Postoperative day 1 and the day of discharge

    Mini Nutritional Assessment Short Form (MNA-SF): Nutritional status will be assessed using the Mini Nutritional Assessment-Short Form (MNA-SF). The total score ranges from 0 to 14, with higher scores indicating better nutritional status.

  7. Psychological Status Assessment - Geriatric Depression Scale (GDS)

    Time frame: Postoperative day 1 and the day of discharge

    Geriatric Depression Scale-15 (Short Form): It is a scale used to screen for depression in older adults. The total score ranges from 0 to 15. Scores of 0-4 indicate no depression, 5-8 indicate mild depression, 9-11 indicate moderate depression, and 12-15 indicate severe depression.

Sponsors and collaborators

Lead sponsor

SELDA MERT

Other

Registry information

Official study title

The Effect of Targeted Individualized Nursing Care Interventions on Frailty Levels and Clinical Outcomes in Frail Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Apr 22, 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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