FrailityNCT07633483
The Relationship Between Preoperative Anxiety Level and Frailty Score in Elderly Patients Scheduled for Elective Hip Arthroplasty: A Prospective Observational Study
An observational study of Fraility and Anxiety, Preoperative, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fraility, Anxiety, Preoperative, Hip Arthroplasty
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 1 Jul 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Çam Ve Sakura City Hospital, İstanbul, Türkiye
Istanbul, Istanbul, 34480
About this study
Official title: Assessment of the Relationship Between Preoperative Anxiety Level Measured by the Hamilton Anxiety Rating Scale and Frailty Score Assessed by the FRAIL Scale in Elderly Patients Aged 65 Years and Older Scheduled for Elective Hip Arthroplasty: A Prospective Observational Single-Center Study
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.
Read the 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.
- Conditions
- Fraility, Anxiety, Preoperative, Hip Arthroplasty
- Keywords
- Fraility, FRAIL Scale, Preoperative Anxiety, Hamilton Anxiety Rating Scale, Hip Arthroplasty, Elderly, Geriatric, Observational Study, Anesthesiology
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours before surgery
Secondary outcomes (12)
Prevalence of Frailty
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.
Measured: 24 hours before surgery
Prevalence of Preoperative Anxiety
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.
Measured: 24 hours before surgery
Correlation Between Frailty Score and Length of Hospital Stay
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.
Measured: From hospital admission to discharge, assessed up to 2 weeks
Correlation Between Preoperative Anxiety Level and Length of Hospital Stay
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.
Measured: From surgery to discharge, assessed up to 2 weeks
Correlation Between Frailty Score and Postoperative ICU Admission Rate
Correlation Between Frailty Score and Postoperative ICU Admission Rate
Measured: From hospital admission to discharge, assessed up to 2 weeks
Correlation Between Preoperative Anxiety Level and Postoperative ICU Admission Rate
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).
Measured: From surgery to discharge, assessed up to 2 weeks
Correlation Between Frailty Score and In-Hospital Mortality Rate
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.
Measured: From hospital admission to discharge, assessed up to 2 weeks
Correlation Between Preoperative Anxiety Level and In-Hospital Mortality Rate
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.
Measured: From hospital admission to discharge, assessed up to 2 weeks
Association Between Frailty Score and Sociodemographic Characteristics
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.
Measured: 24 hours before surgery
Association Between Preoperative Anxiety Level and Sociodemographic Characteristics
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.
Measured: 24 hours before surgery
Correlation Between Frailty Score and Preoperative Laboratory Parameters
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).
Measured: At hospital admission
Correlation Between Preoperative Anxiety Level and Preoperative Laboratory Parameters
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).
Measured: At hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Dec 2024
- Primary completion15 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for FrailityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muzaffer GENCER, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633483
- Sponsor's protocol ID
- BSH-ANES-MYM-01
- Status last verified
- Jun 2026
- First submitted
- 31 May 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gautam P, Mittal P, Gautam S, Rawat V. Anxiety disorder: Definition, symptoms, causes, epidemiology and treatments. Food and Health. 2022;4(4).
Sadock BJ, Sadock VA. Kaplan and Sadock's Comprehensive Textbook of Psychiatry. Güneş Kitabevleri. p. 1559-800.
Muradi H. Yaşlılarda kırılganlığı ölçmeye yönelik FRAİL ölçeğinin Türkçe geçerlilik ve güvenilirlik çalışması. Hacettepe Üniversitesi Tıp Fakültesi. 2017.
Özşaker E. Elderly Surgery Patients and Frailty Syndrome. Journal of Samsun Health Sciences. 2022.
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.
PubMed 33949810Tan 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.
PubMed 37157226Steenblock 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.
PubMed 36774453Zimmerman 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.
PubMed 32088508
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Relationship Between Preoperative Anxiety Level Measured by the Hamilton Anxiety Rating Scale and Frailty Score Assessed by the FRAIL Scale in Elderly Patients Aged 65 Years and Older Scheduled for Elective Hip Arthroplasty: A Prospective Observational Single-Center Study
- ClinicalTrials.gov ID
- NCT07633483
- Acronym / sponsor ID
- BSH-ANES-MYM-01
- Conditions
- Fraility, Anxiety, Preoperative, Hip Arthroplasty
- Keywords
- Fraility, FRAIL Scale, Preoperative Anxiety, Hamilton Anxiety Rating Scale, Hip Arthroplasty, Elderly, Geriatric, Observational Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association Between Frailty Score and Preoperative Anxiety Level
Time frame: 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.
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- BackgroundGautam P, Mittal P, Gautam S, Rawat V. Anxiety disorder: Definition, symptoms, causes, epidemiology and treatments. Food and Health. 2022;4(4).
- BackgroundSadock BJ, Sadock VA. Kaplan and Sadock's Comprehensive Textbook of Psychiatry. Güneş Kitabevleri. p. 1559-800.
- BackgroundMuradi H. Yaşlılarda kırılganlığı ölçmeye yönelik FRAİL ölçeğinin Türkçe geçerlilik ve güvenilirlik çalışması. Hacettepe Üniversitesi Tıp Fakültesi. 2017.
- BackgroundÖzşaker E. Elderly Surgery Patients and Frailty Syndrome. Journal of Samsun Health Sciences. 2022.
- Background: PubMed 33949810Wang 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.
- Background: PubMed 37157226Tan 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.
- Background: PubMed 36774453Steenblock 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.
- Background: PubMed 32088508Zimmerman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fraility and Anxiety, Preoperative, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Frailty Score and Preoperative Anxiety Level (time frame: 24 hours before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07633483, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.