Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety

Anxiety Disorders Clinical Trial

Official title:

Comparison of the Effects of Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02511210
• Other study ID #: erzincan university
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2015
• Last updated: December 26, 2015
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2015
• Source: Cukurova University
• Contact: ILKE KUPELI, M.D
• Phone: +905555485632
• Email: ilkeser2004[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The researchers aimed to investigate that preoperative anxiety scores of patients who are informed about the anesthesia before surgery with using State-Trait Anxiety Inventory and Amsterdam preoperative anxiety and information scale tests together.

Description:

Patients will be informed about the anesthesia procedure in service ad then It will be held anxiety questionnaires one day before surgery and operation rooms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 80,

• both women and men,

• Patients will be operated

Exclusion Criteria:

• psychiatric and neurologic diseases,

• hearing and speech disorders,

• Psychiatric drug and chronic alcohol use

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• regional anesthesia
preoperative anxiety
• general anesthesia
preoperative anxiety

Locations

Country	Name	City	State
Turkey	Mengucek Gazi Training and Research Hospital	Erzincan	Merkez

Sponsors (2)

Lead Sponsor	Collaborator
Cukurova University	Erzincan University

Country where clinical trial is conducted

Turkey, 

References & Publications (14)

Badner NH, Nielson WR, Munk S, Kwiatkowska C, Gelb AW. Preoperative anxiety: detection and contributing factors. Can J Anaesth. 1990 May;37(4 Pt 1):444-7. — View Citation

Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Adamatti LC, Bandeira D, Ferreira MB. Risk factors for postoperative anxiety in adults. Anaesthesia. 2001 Aug;56(8):720-8. — View Citation

Deniz Erdem, Cengiz Ugis, M. Demet Albayrak, Belgin Akan, Esra Aksoy, Nermin Gögüs. Perianal Bölge Ameliyati Yapilacak Hastalarda Uygulanan Anestezi Yöntemlerinin Preoperatif ve Postoperatif Anksiyete ve Agri Düzeylerine Etkisi. Bakirköy Tip Dergisi 2011;

Hicks JA, Jenkins JG. The measurement of preoperative anxiety. J R Soc Med. 1988 Sep;81(9):517-9. — View Citation

Johnston M. Anxiety in surgical patients. Psychol Med. 1980 Feb;10(1):145-52. — View Citation

Kain ZN, Kosarussavadi B, Hernandez-Conte A, Hofstadter MB, Mayes LC. Desire for perioperative information in adult patients: a cross-sectional study. J Clin Anesth. 1997 Sep;9(6):467-72. — View Citation

Kain ZN, Wang SM, Caramico LA, Hofstadter M, Mayes LC. Parental desire for perioperative information and informed consent: a two-phase study. Anesth Analg. 1997 Feb;84(2):299-306. — View Citation

Maheshwari D, Ismail S. Preoperative anxiety in patients selecting either general or regional anesthesia for elective cesarean section. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):196-200. doi: 10.4103/0970-9185.155148. — View Citation

Markland D, Hardy L. Anxiety, relaxation and anaesthesia for day-case surgery. Br J Clin Psychol. 1993 Nov;32 ( Pt 4):493-504. — View Citation

Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. — View Citation

Norris W, Baird WL. Pre-operative anxiety: a study of the incidence and aetiology. Br J Anaesth. 1967 Jun;39(6):503-9. — View Citation

Perks A, Chakravarti S, Manninen P. Preoperative anxiety in neurosurgical patients. J Neurosurg Anesthesiol. 2009 Apr;21(2):127-30. doi: 10.1097/ANA.0b013e31819a6ca3. — View Citation

Spielberger CD, Auerbach SM, Wadsworth AP, Dunn TM, Taulbee ES. Emotional reactions to surgery. J Consult Clin Psychol. 1973 Feb;40(1):33-8. — View Citation

Tenenbaum G, Furst D, Weingarten G. A statistical reevaluation of the STAI anxiety questionnaire. J Clin Psychol. 1985 Mar;41(2):239-44. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia		two months	No
Secondary	State-Trait Anxiety Inventory scores in operating rooms		two months	No
Secondary	Amsterdam Preoperative Anxiety and Information Scale scores in operating rooms		two months	No
Secondary	Amsterdam Preoperative Anxiety and Information Scale scores in patients undergoing regional anesthesia		two months	No