Anxiety, Preoperative, Fraility, Hip Arthroplasty
Conditions
Keywords
Fraility, FRAIL Scale, Preoperative Anxiety, Hamilton Anxiety Rating Scale, Hip Arthroplasty, Elderly, Geriatric, Observational Study, Anesthesiology
Brief summary
Frailty is a state of vulnerability resulting from decreased physiological reserve across multiple organ systems, impairing an individual's ability to withstand stressors. As the elderly population grows worldwide, the proportion of older adults undergoing surgical procedures continues to rise, and frailty is expected to become increasingly prevalent among surgical candidates. Anxiety is one of the most common psychiatric conditions, affecting approximately one in three individuals globally. Preoperative anxiety may negatively influence surgical outcomes, particularly in older and more vulnerable patients. This prospective observational study aims to evaluate the relationship between preoperative anxiety level and frailty score in elderly patients aged 65 years and older scheduled for elective hip arthroplasty. Frailty will be assessed using the FRAIL Scale (Fatigue, Resistance, Ambulation, Illness, Loss of Weight), and anxiety will be measured using the Hamilton Anxiety Rating Scale (HAM-A). Secondary outcomes include the prevalence of frailty and anxiety, the effect of frailty on length of hospital stay, postoperative intensive care unit admission rates, and the relationship between frailty and preoperative laboratory and hemodynamic parameters.
Detailed description
Background: The population aged 65 years and older is growing rapidly worldwide. In Turkey, this demographic increased by 21.4% between 2018 and 2023, reaching over 8.7 million individuals, and is projected to constitute 25.6% of the total population by 2080. Parallel to this trend, the number of elderly patients undergoing surgical procedures is rising, and frailty is expected to become increasingly common among surgical candidates. Frailty is defined as a state of vulnerability arising from decreased physiological reserve and function across multiple organ systems. The FRAIL Scale, developed by Morley et al. in 2012, is a validated five-item tool assessing Fatigue, Resistance, Ambulation, Illness, and Loss of Weight. Each item is scored 0 or 1, yielding a total score of 0-5. Patients scoring 0 are classified as robust, those scoring 1-2 as pre-frail, and those scoring 3-5 as frail. The Turkish validity and reliability of the FRAIL Scale was established in 2017 at Hacettepe University Faculty of Medicine. Anxiety is among the most prevalent psychiatric conditions globally. The Hamilton Anxiety Rating Scale (HAM-A), developed in 1959, is a widely used clinician-administered instrument for assessing anxiety severity, consisting of 14 items with a total score range of 0-56. While the association between frailty and depression has been explored in the literature, studies specifically examining the relationship between frailty and preoperative anxiety remain limited. A 2023 systematic review identified a need for further research on this topic. Study Design: This is a prospective, observational, single-center study conducted at the Anesthesiology and Reanimation Clinic of Başakşehir Çam and Sakura City Hospital, University of Health Sciences, Istanbul, Turkey. Study Procedures: Eligible patients will be assessed during three visits: Visit 1 (Day of Admission): Routine preoperative anesthesia evaluation including ASA physical status classification, medical comorbidities, perioperative risk assessment, hemodynamic parameters (systolic, diastolic, and mean arterial pressure; heart rate; SpO2), and laboratory values (hemoglobin, albumin, GFR). Visit 2 (24 Hours Before Surgery): Informed consent will be obtained. The FRAIL Scale and Hamilton Anxiety Rating Scale will be administered. Sociodemographic data will be collected, including age, sex, occupation, educational status, marital status, number of household members, alcohol and tobacco use, psychiatric history, and current medications. Hemodynamic parameters will be re-recorded. Visit 3 (Day of Discharge): Hemodynamic parameters will be recorded. Length of hospital stay and postoperative intensive care unit (ICU) admission duration (if applicable) will be documented. All data will be recorded and transferred to an electronic database for statistical analysis. Outcomes: The primary outcome is the association between frailty score (FRAIL Scale) and preoperative anxiety level (HAM-A) in elderly patients scheduled for elective hip arthroplasty. Secondary outcomes include: Prevalence of frailty and anxiety in the study population Effect of frailty score on length of hospital stay Effect of frailty score on postoperative ICU admission rate Relationship between frailty score and preoperative hemodynamic and laboratory parameters (hemoglobin, albumin, GFR) Sample Size: Based on a similar study by Wang et al. (2021) examining the relationship between frailty, depression, and anxiety in elderly surgical patients, a minimum sample size of 142 patients was calculated (95% power, type I error 0.05, effect size h=0.305). A total of 167 patients will be enrolled to account for potential dropouts. Statistical Analysis: Data will be analyzed using SPSS version 22.0. Descriptive statistics will include frequency and percentage for categorical variables, and minimum, maximum, mean, and standard deviation for continuous variables. Normality will be assessed using the Kolmogorov-Smirnov and Shapiro-Wilk tests. Parametric tests (independent samples t-test, ANOVA) will be applied for normally distributed data, and non-parametric tests (Mann-Whitney U, Kruskal-Wallis) for non-normally distributed data. Correlation and regression analyses will be performed to evaluate associations and effect sizes. A p-value of less than 0.05 will be considered statistically significant. Ethical Considerations: The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Informed written consent will be obtained from all participants prior to enrollment. No additional interventions beyond routine clinical practice will be performed.
Interventions
None listed
Sponsors
Başakşehir Çam & Sakura City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of both sexes aged 65 years and older * Patients with ASA physical status classification I, II, or III scheduled for elective hip arthroplasty * Patients who voluntarily agree to participate in the study * Patients with intact orientation and sufficient cooperation for assessment
Exclusion criteria
* Patients with ASA physical status classification IV or V * Patients who refuse to participate in the study * Patients with impaired orientation or insufficient cooperation for assessment * Patients scheduled for emergency surgery * Patients to be operated during an active intensive care unit admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Frailty Score and Preoperative Anxiety Level | 24 hours before surgery | The primary outcome is to evaluate the relationship between frailty score assessed by the FRAIL Scale (Fatigue, Resistance, Ambulation, Illness, Loss of Weight; total score range 0-5) and preoperative anxiety level measured by the Hamilton Anxiety Rating Scale (HAM-A; total score range 0-56) in elderly patients aged 65 years and older scheduled for elective hip arthroplasty. A higher FRAIL Scale score indicates greater frailty, and a higher HAM-A score indicates greater anxiety severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Frailty | 24 hours before surgery | The proportion of participants classified as robust (FRAIL Scale score 0), pre-frail (score 1-2), and frail (score 3-5) within the study population. |
| Prevalence of Preoperative Anxiety | 24 hours before surgery | The proportion of participants classified as no anxiety (HAM-A score 0-5), minor anxiety (score 6-14), and major anxiety (score 15 and above) within the study population. |
| Correlation Between Frailty Score and Length of Hospital Stay | From hospital admission to discharge, assessed up to 2 weeks | Correlation between frailty score assessed by the FRAIL Scale (score range 0-5, units on a scale) and total length of hospital stay (in days) from admission to discharge. |
| Correlation Between Preoperative Anxiety Level and Length of Hospital Stay | From surgery to discharge, assessed up to 2 weeks | Correlation between preoperative anxiety level measured by the Hamilton Anxiety Rating Scale (HAM-A; score range 0-56, units on a scale) and total length of hospital stay (in days) from admission to discharge. |
| Correlation Between Frailty Score and Postoperative ICU Admission Rate | From hospital admission to discharge, assessed up to 2 weeks | Correlation Between Frailty Score and Postoperative ICU Admission Rate |
| Correlation Between Preoperative Anxiety Level and Postoperative ICU Admission Rate | From surgery to discharge, assessed up to 2 weeks | Correlation between preoperative anxiety level measured by the Hamilton Anxiety Rating Scale (HAM-A; score range 0-56, units on a scale) and postoperative intensive care unit (ICU) admission rate (% of patients admitted to ICU). |
| Correlation Between Frailty Score and In-Hospital Mortality Rate | From hospital admission to discharge, assessed up to 2 weeks | Correlation between frailty score assessed by the FRAIL Scale (score range 0-5, units on a scale) and in-hospital mortality rate (% of patients who died) during the index hospitalization for elective hip arthroplasty. |
| Correlation Between Preoperative Anxiety Level and In-Hospital Mortality Rate | From hospital admission to discharge, assessed up to 2 weeks | Correlation between preoperative anxiety level measured by the Hamilton Anxiety Rating Scale (HAM-A; score range 0-56, units on a scale) and in-hospital mortality rate (% of patients who died) during the index hospitalization for elective hip arthroplasty. |
| Association Between Frailty Score and Sociodemographic Characteristics | 24 hours before surgery | Association between frailty score assessed by the FRAIL Scale (score range 0-5, units on a scale) and sociodemographic variables including age (years), sex, educational status, marital status, number of household members, occupational status, alcohol and tobacco use, psychiatric history, and current medication use. |
| Association Between Preoperative Anxiety Level and Sociodemographic Characteristics | 24 hours before surgery | Association between preoperative anxiety level measured by the Hamilton Anxiety Rating Scale (HAM-A; score range 0-56, units on a scale) and sociodemographic variables including age (years), sex, educational status, marital status, number of household members, occupational status, alcohol and tobacco use, psychiatric history, and current medication use. |
| Correlation Between Frailty Score and Preoperative Laboratory Parameters | At hospital admission | Correlation between frailty score assessed by the FRAIL Scale (score range 0-5, units on a scale) and preoperative laboratory values including hemoglobin (g/dL), serum albumin (g/dL), and glomerular filtration rate (GFR, mL/min/1.73m²). |
| Correlation Between Preoperative Anxiety Level and Preoperative Laboratory Parameters | At hospital admission | Correlation between preoperative anxiety level measured by the Hamilton Anxiety Rating Scale (HAM-A; score range 0-56, units on a scale) and preoperative laboratory values including hemoglobin (g/dL), serum albumin (g/dL), and glomerular filtration rate (GFR, mL/min/1.73m²). |
Countries
Turkey (Türkiye)
Outcome results
None listed