Clinical trial NCT02511210: Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety
Official title: Comparison of the Effects of Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Cukurova University
Sponsor class: OTHER
Collaborators: name: Erzincan University
First posted: 2015-07-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia
timeFrame: two months
Secondary outcomes:
measure: State-Trait Anxiety Inventory scores in operating rooms
timeFrame: two months
measure: Amsterdam Preoperative Anxiety and Information Scale scores in operating rooms
timeFrame: two months
measure: Amsterdam Preoperative Anxiety and Information Scale scores in patients undergoing regional anesthesia
timeFrame: two months
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Mengucek Gazi Training and Research Hospital
state: Merkez
Study officials:
affiliation: Erzincan University
name: ILKE KUPELI, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1097/00000539-199603000-00002.
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. doi: 10.1046/j.1365-2044.2001.01842.x.
citation: Markland D, Hardy L. Anxiety, relaxation and anaesthesia for day-case surgery. Br J Clin Psychol. 1993 Nov;32(4):493-504. doi: 10.1111/j.2044-8260.1993.tb01085.x.
citation: 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. doi: 10.1007/BF03005624.
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. doi: 10.1016/s0952-8180(97)00102-5.
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. doi: 10.1097/00000539-199702000-00011.
citation: Tenenbaum G, Furst D, Weingarten G. A statistical reevaluation of the STAI anxiety questionnaire. J Clin Psychol. 1985 Mar;41(2):239-44. doi: 10.1002/1097-4679(198503)41:23.0.co;2-5.
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. doi: 10.1037/h0033982. No abstract available.
citation: Norris W, Baird WL. Pre-operative anxiety: a study of the incidence and aetiology. Br J Anaesth. 1967 Jun;39(6):503-9. doi: 10.1093/bja/39.6.503. No abstract available.
citation: Hicks JA, Jenkins JG. The measurement of preoperative anxiety. J R Soc Med. 1988 Sep;81(9):517-9. doi: 10.1177/014107688808100907.
citation: Johnston M. Anxiety in surgical patients. Psychol Med. 1980 Feb;10(1):145-52. doi: 10.1017/s0033291700039684.
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.
citation: Deniz Erdem, Cengiz Ugiş, M. Demet Albayrak, Belgin Akan, Esra Aksoy, Nermin Göğüş. Perianal Bölge Ameliyatı Yapılacak Hastalarda Uygulanan Anestezi Yöntemlerinin Preoperatif ve Postoperatif Anksiyete ve Ağrı Düzeylerine Etkisi. Bakırköy Tıp Dergisi 2011;7:11-16