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

NCT02511210 | Unknown

• 1 other identifier: erzincan university
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia

  two months

Secondary Outcomes (3)

• State-Trait Anxiety Inventory scores in operating rooms

  two months

• Amsterdam Preoperative Anxiety and Information Scale scores in operating rooms

  two months

• Amsterdam Preoperative Anxiety and Information Scale scores in patients undergoing regional anesthesia

  two months

Study Arms (2)

regional anesthesia

ACTIVE COMPARATOR

spinal anesthesia or peripheral nerve block

Behavioral: regional anesthesia

general anesthesia

ACTIVE COMPARATOR

intubated patients

Behavioral: general anesthesia

Interventions

regional anesthesia BEHAVIORAL

preoperative anxiety

regional anesthesia

general anesthesia BEHAVIORAL

preoperative anxiety

general anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 80,
• both women and men,
• Patients will be operated

You may not qualify if:

• psychiatric and neurologic diseases,
• hearing and speech disorders,
• Psychiatric drug and chronic alcohol use

Sponsors & Collaborators

• Cukurova University: lead
• Erzincan University: collaborator

Study Sites (1)

Mengucek Gazi Training and Research Hospital

Erzincan, Merkez, 24100, Turkey (Türkiye)

RECRUITING

Related Publications (14)

• 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.

  PMID: 19295391 BACKGROUND

• 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.

  PMID: 8623940 BACKGROUND

• 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.

  PMID: 11493233 BACKGROUND

• 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.

  PMID: 8298547 BACKGROUND

• 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.

  PMID: 2340614 BACKGROUND

• 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.

  PMID: 9278833 BACKGROUND

• 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.

  PMID: 9024018 BACKGROUND

• 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.

  PMID: 3980747 BACKGROUND

• 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.

  PMID: 4688678 RESULT

• 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.

  PMID: 6027959 RESULT

• Hicks JA, Jenkins JG. The measurement of preoperative anxiety. J R Soc Med. 1988 Sep;81(9):517-9. doi: 10.1177/014107688808100907.

  PMID: 3184108 RESULT

• Johnston M. Anxiety in surgical patients. Psychol Med. 1980 Feb;10(1):145-52. doi: 10.1017/s0033291700039684.

  PMID: 7384316 RESULT

• 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.

  PMID: 25948900 RESULT

• 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

  RESULT

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Anesthesia, Conduction; Anesthesia, General

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• ILKE KUPELI, M.D

  Erzincan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ILKE KUPELI, M.D

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: July 24, 2015
• First Posted: July 29, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 29, 2015

Record last verified: 2015-09

Locations

TU (1)