The Effect of Anaesthesia Technique on Anxiety in Upper Extremity Surgery Patients

NCT06667596 | Withdrawn

• 1 other identifier: EK3604
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, cross-sectional study aims to investigate the impact of planned anesthesia technique (general or regional anesthesia) and patients' previous anesthesia experience on preoperative anxiety in patients undergoing upper extremity surgery. The secondary objective is to identify the reasons for patients' anxiety related to anesthesia and surgery. Preoperative anxiety can lead to emotional, psychiatric, and physical problems, and is associated with increased autonomic fluctuations, anesthetic demand, postoperative nausea and vomiting, pain, prolonged recovery time, and hospitalization. The study will enroll 400 volunteers undergoing upper extremity surgery at Başakşehir Çam and Sakura City Hospital. Demographic information, surgical details, previous surgical and psychiatric history, substance abuse, and information about anesthesia will be collected. The Amsterdam Preoperative Anxiety and Information Form (APAIS) will be used to assess anxiety and desire for information, while the State-Trait Anxiety Inventory (STAI) will evaluate state and trait anxiety. Patients with an APAIS-A score ≥13 will be considered anxious, and those with an APAIS-B score ≥4 will be considered information-seeking. STAI scores will be interpreted based on percentile ranks and average score levels. The study aims to identify approaches to reduce preoperative anesthesia and surgery-related anxiety. SPSS Survey Analysis methods will be used for statistical analysis. The study duration is 12 months, from November 2024 to November 2025. Inclusion criteria are consenting patients aged 18-65 years, ASA I-III, undergoing upper extremity surgery under general or regional anesthesia, who are oriented and cooperative. Exclusion criteria include lack of consent, inappropriate age, ASA IV-V, non-upper extremity surgery, and inability to orient and cooperate.

Conditions

Preoperative Anxiety

Keywords

Preoperative anxiety; Upper extremity surgery; Peripheric nerve block; Regional Anesthesia; General Anesthesia; Anesthesia Anxiety; Surgery Anxiety

Outcome Measures

Primary Outcomes (1)

• APAIS (The Amsterdam Preoperative Anxiety and Information Scale)

  The Amsterdam Preoperative Anxiety and Information Scale The APAIS form includes 6 statements measuring anxiety and desire for information. Patients will be asked to give a value between 1-5 to 4 statements measuring anxiety (1, 2, 4 and 5.) and 2 statements measuring desire for information (3 and 6). The sum of the values given to the statements measuring anxiety constitutes the APAIS-A anxiety score, and the sum of the values given to the statements measuring the desire for information constitutes the APAIS-B desire for information score. Patients with an APAIS-A anxiety score of 13 and above will be considered 'anxious' and patients with an APAIS-B information seeking score of 4 and above will be considered 'seeking information'.

  November 2024- June 2025

Secondary Outcomes (1)

• STAI-TX-1( State Anxiety Scale) and STA-TX-2 (Trait Anxiety Scale)

  November 2024- June 2025

Study Arms (1)

anxiety

Patients aged 18-65 years, ASA-I-II-III, oriented and cooperative, who agreed to participate in the survey, undergoing upper extremity surgery under regional or general anesthesia.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers will be selected among the patients who will undergo upper extremity surgery (shoulder, arm, wrist, hand) in the Orthopedics and Hand Surgery Clinics of Başakşehir Çam and Sakura City Hospital after ethics committee approval is obtained. The statistical sample size calculation was found to be 400 patients as a result of the statistical sample size calculation considering a 5% margin of error at 95% confidence interval.

You may qualify if:

• Consenting patients,
• years old,
• ASA-I-II-III
• They will undergo upper extremity (shoulder, arm, wrist, hand) surgery,
• They will receive General or Regional Anesthesia,
• Oriented and cooperative patients,

You may not qualify if:

• Patients without consent,
• Not in the appropriate age range,
• Patients with ASA-IV-V,
• Those who will not undergo upper extremity surgery,
• Patients who cannot orient and cooperate

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam ve Sakura Şehir Hastanesi

Istanbul, Başakşehir, 34480, Turkey (Türkiye)

Location

Related Publications (4)

• Oh J, Lee W, Ki S, Suh J, Hwang S, Lee J. Assessment of Preoperative Anxiety and Influencing Factors in Patients Undergoing Elective Surgery: An Observational Cross-Sectional Study. Medicina (Kaunas). 2024 Feb 27;60(3):403. doi: 10.3390/medicina60030403.

  PMID: 38541129 BACKGROUND

• Salzmann S, Rienmuller S, Kampmann S, Euteneuer F, Rusch D. Preoperative anxiety and its association with patients' desire for support - an observational study in adults. BMC Anesthesiol. 2021 May 17;21(1):149. doi: 10.1186/s12871-021-01361-2.

  PMID: 34000986 BACKGROUND

• Eberhart L, Aust H, Schuster M, Sturm T, Gehling M, Euteneuer F, Rusch D. Preoperative anxiety in adults - a cross-sectional study on specific fears and risk factors. BMC Psychiatry. 2020 Mar 30;20(1):140. doi: 10.1186/s12888-020-02552-w.

  PMID: 32228525 BACKGROUND

• Sertcakacilar G, Yildiz GO, Bayram B, Pektas Y, Cukurova Z, Hergunsel GO. Comparing Preoperative Anxiety Effects of Brachial Plexus Block and General Anesthesia for Orthopedic Upper-Extremity Surgery: A Randomized, Controlled Trial. Medicina (Kaunas). 2022 Sep 16;58(9):1296. doi: 10.3390/medicina58091296.

  PMID: 36143973 BACKGROUND

Related Links

• pubmed

Study Officials

• Emine Ozcan, Principal Investigator

  Başakşehir Çam ve Sakura Şehir Hastanesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)