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

NCT07633483 | Recruiting

• 1 other identifier: BSH-ANES-MYM-01
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Arthroplasty; Fraility; Anxiety, Preoperative

Keywords

Fraility; FRAIL Scale; Preoperative Anxiety; Hamilton Anxiety Rating Scale; Hip Arthroplasty; Elderly; Geriatric; Observational Study; Anesthesiology

Outcome Measures

Primary Outcomes (1)

• Association Between Frailty Score and Preoperative Anxiety Level

  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.

  24 hours before surgery

Secondary Outcomes (12)

• Prevalence of Frailty

  24 hours before surgery

• Prevalence of Preoperative Anxiety

  24 hours before surgery

• Correlation Between Frailty Score and Length of Hospital Stay

  From hospital admission to discharge, assessed up to 2 weeks

• Correlation Between Preoperative Anxiety Level and Length of Hospital Stay

  From surgery to discharge, assessed up to 2 weeks

• Correlation Between Frailty Score and Postoperative ICU Admission Rate

  From hospital admission to discharge, assessed up to 2 weeks

Study Arms (3)

Robust

Participants with a FRAIL Scale score of 0, indicating no signs of frailty.

Pre-Frail

Participants with a FRAIL Scale score of 1-2, indicating early signs of frailty.

Frail

Participants with a FRAIL Scale score of 3-5, meeting the criteria for frailty.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 65 years and older of both sexes scheduled for elective total hip arthroplasty at the Anesthesiology and Reanimation Clinic of Başakşehir Çam and Sakura City Hospital, University of Health Sciences, Istanbul, Turkey. Participants were enrolled between December 2024 and June 2026.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Çam Ve Sakura City Hospital, İstanbul, Türkiye

Istanbul, Istanbul, 34480, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• Gautam P, Mittal P, Gautam S, Rawat V. Anxiety disorder: Definition, symptoms, causes, epidemiology and treatments. Food and Health. 2022;4(4).

  BACKGROUND

• Sadock BJ, Sadock VA. Kaplan and Sadock's Comprehensive Textbook of Psychiatry. Güneş Kitabevleri. p. 1559-800.

  BACKGROUND

• Muradi H. Yaşlılarda kırılganlığı ölçmeye yönelik FRAİL ölçeğinin Türkçe geçerlilik ve güvenilirlik çalışması. Hacettepe Üniversitesi Tıp Fakültesi. 2017.

  BACKGROUND

• Özşaker E. Elderly Surgery Patients and Frailty Syndrome. Journal of Samsun Health Sciences. 2022.

  BACKGROUND

• Wang S, Cardieri B, Mo Lin H, Liu X, Sano M, Deiner SG. Depression and anxiety symptoms are related to pain and frailty but not cognition or delirium in older surgical patients. Brain Behav. 2021 Jun;11(6):e02164. doi: 10.1002/brb3.2164. Epub 2021 May 5.

  PMID: 33949810 BACKGROUND

• Tan M, Bhanu C, Frost R. The association between frailty and anxiety: A systematic review. Int J Geriatr Psychiatry. 2023 May;38(5):e5918. doi: 10.1002/gps.5918.

  PMID: 37157226 BACKGROUND

• Steenblock J, Braisch U, Brefka S, Thomas C, Eschweiler GW, Rapp M, Metz B, Maurer C, von Arnim CAF, Herrmann ML, Wagner S, Denkinger M, Dallmeier D. Frailty index and its association with the onset of postoperative delirium in older adults undergoing elective surgery. BMC Geriatr. 2023 Feb 11;23(1):90. doi: 10.1186/s12877-022-03663-7.

  PMID: 36774453 BACKGROUND

• Zimmerman M, Thompson JS, Diehl JM, Balling C, Kiefer R. Is the DSM-5 Anxious Distress Specifier Interview a valid measure of anxiety in patients with generalized anxiety disorder: A comparison to the Hamilton Anxiety Scale. Psychiatry Res. 2020 Apr;286:112859. doi: 10.1016/j.psychres.2020.112859. Epub 2020 Feb 9.

  PMID: 32088508 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Muzaffer GENCER

CONTACT

+905059436459; myasinmersin@gmail.com

Murat Yasin MERSİN

CONTACT

+905367736432; dr.m.gencer07@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Doctor

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 8, 2026
• Study Start: December 1, 2024
• Primary Completion: June 15, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)