The Relationship Between Preoperative Anxiety Level and Frailty Score in Elderly Patients Scheduled for Elective Hip Arthroplasty: A Prospective Observational Study

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.

• Prevalence of Frailty [Time frame: 24 hours before surgery]
• Prevalence of Preoperative Anxiety [Time frame: 24 hours before surgery]
• Correlation Between Frailty Score and Length of Hospital Stay [Time frame: From hospital admission to discharge, assessed up to 2 weeks]
• Correlation Between Preoperative Anxiety Level and Length of Hospital Stay [Time frame: From surgery to discharge, assessed up to 2 weeks]
• Correlation Between Frailty Score and Postoperative ICU Admission Rate [Time frame: From hospital admission to discharge, assessed up to 2 weeks]
• Correlation Between Preoperative Anxiety Level and Postoperative ICU Admission Rate [Time frame: From surgery to discharge, assessed up to 2 weeks]
• Correlation Between Frailty Score and In-Hospital Mortality Rate [Time frame: From hospital admission to discharge, assessed up to 2 weeks]
• Correlation Between Preoperative Anxiety Level and In-Hospital Mortality Rate [Time frame: From hospital admission to discharge, assessed up to 2 weeks]
• Association Between Frailty Score and Sociodemographic Characteristics [Time frame: 24 hours before surgery]
• Association Between Preoperative Anxiety Level and Sociodemographic Characteristics [Time frame: 24 hours before surgery]
• Correlation Between Frailty Score and Preoperative Laboratory Parameters [Time frame: At hospital admission]
• Correlation Between Preoperative Anxiety Level and Preoperative Laboratory Parameters [Time frame: At hospital admission]