- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02511210
Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety
December 26, 2015 updated by: ILKE KUPELI, Cukurova University
Comparison of the Effects of Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merkez
-
Erzincan, Merkez, Turkey, 24100
- Recruiting
- Mengucek Gazi Training and Research Hospital
-
Contact:
- ILKE KUPELI, M.D
- Phone Number: +905555485632
- Email: ilkeser2004@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: regional anesthesia
spinal anesthesia or peripheral nerve block
|
preoperative anxiety
|
Active Comparator: general anesthesia
intubated patients
|
preoperative anxiety
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia
Time Frame: two months
|
two months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
State-Trait Anxiety Inventory scores in operating rooms
Time Frame: two months
|
two months
|
Amsterdam Preoperative Anxiety and Information Scale scores in operating rooms
Time Frame: two months
|
two months
|
Amsterdam Preoperative Anxiety and Information Scale scores in patients undergoing regional anesthesia
Time Frame: two months
|
two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: ILKE KUPELI, M.D, Erzincan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Hicks JA, Jenkins JG. The measurement of preoperative anxiety. J R Soc Med. 1988 Sep;81(9):517-9. doi: 10.1177/014107688808100907.
- Johnston M. Anxiety in surgical patients. Psychol Med. 1980 Feb;10(1):145-52. doi: 10.1017/s0033291700039684.
- 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.
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
July 24, 2015
First Submitted That Met QC Criteria
July 27, 2015
First Posted (Estimate)
July 29, 2015
Study Record Updates
Last Update Posted (Estimate)
December 29, 2015
Last Update Submitted That Met QC Criteria
December 26, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- erzincan university
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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