Back to resultsRegional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety
Primary Purpose
Anxiety Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
regional anesthesia
general anesthesia
Sponsored by
About this trial
This is an interventional diagnostic trial for Anxiety Disorders
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
Sites / Locations
- Mengucek Gazi Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
regional anesthesia
general anesthesia
Arm Description
spinal anesthesia or peripheral nerve block
intubated patients
Outcomes
Primary Outcome Measures
State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia
Secondary Outcome Measures
State-Trait Anxiety Inventory scores in operating rooms
Amsterdam Preoperative Anxiety and Information Scale scores in operating rooms
Amsterdam Preoperative Anxiety and Information Scale scores in patients undergoing regional anesthesia
Full Information
NCT ID
NCT02511210
First Posted
July 24, 2015
Last Updated
December 26, 2015
Sponsor
Cukurova University
Collaborators
Erzincan University
1. Study Identification
Unique Protocol Identification Number
NCT02511210
Brief Title
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
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
Collaborators
Erzincan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
regional anesthesia
Arm Type
Active Comparator
Arm Description
spinal anesthesia or peripheral nerve block
Arm Title
general anesthesia
Arm Type
Active Comparator
Arm Description
intubated patients
Intervention Type
Behavioral
Intervention Name(s)
regional anesthesia
Intervention Description
preoperative anxiety
Intervention Type
Behavioral
Intervention Name(s)
general anesthesia
Intervention Description
preoperative anxiety
Primary Outcome Measure Information:
Title
State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia
Time Frame
two months
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory scores in operating rooms
Time Frame
two months
Title
Amsterdam Preoperative Anxiety and Information Scale scores in operating rooms
Time Frame
two months
Title
Amsterdam Preoperative Anxiety and Information Scale scores in patients undergoing regional anesthesia
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ILKE KUPELI, M.D
Phone
+905555485632
Email
ilkeser2004@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ILKE KUPELI, M.D
Organizational Affiliation
Erzincan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mengucek Gazi Training and Research Hospital
City
Erzincan
State/Province
Merkez
ZIP/Postal Code
24100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ILKE KUPELI, M.D
Phone
+905555485632
Email
ilkeser2004@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
19295391
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.
Results Reference
background
PubMed Identifier
8623940
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.
Results Reference
background
PubMed Identifier
11493233
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.
Results Reference
background
PubMed Identifier
8298547
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.
Results Reference
background
PubMed Identifier
2340614
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.
Results Reference
background
PubMed Identifier
9278833
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.
Results Reference
background
PubMed Identifier
9024018
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.
Results Reference
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PubMed Identifier
3980747
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.
Results Reference
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PubMed Identifier
4688678
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.
Results Reference
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PubMed Identifier
6027959
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.
Results Reference
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PubMed Identifier
3184108
Citation
Hicks JA, Jenkins JG. The measurement of preoperative anxiety. J R Soc Med. 1988 Sep;81(9):517-9. doi: 10.1177/014107688808100907.
Results Reference
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PubMed Identifier
7384316
Citation
Johnston M. Anxiety in surgical patients. Psychol Med. 1980 Feb;10(1):145-52. doi: 10.1017/s0033291700039684.
Results Reference
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PubMed Identifier
25948900
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.
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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
Results Reference
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Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety
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