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Status unknownNCT02511210Updated Dec 29, 2015

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

An interventional study of regional anesthesia and general anesthesia in Anxiety Disorders, sponsored by Cukurova University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-12-29.

Sponsored by Cukurova University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Anxiety Disorders

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 500 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Cukurova University is the lead sponsor of 247 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Active comparator
    regional anesthesia

    spinal anesthesia or peripheral nerve block

    Behavioral: regional anesthesia

  • Active comparator
    general anesthesia

    intubated patients

    Behavioral: general anesthesia

Interventions

  • Behavioralregional anesthesia

    preoperative anxiety

  • Behavioralgeneral anesthesia

    preoperative anxiety

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What researchers measure

Primary outcomes

  1. State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia

    Time frame: two months

Secondary outcomes

  1. State-Trait Anxiety Inventory scores in operating rooms

    Time frame: two months

  2. Amsterdam Preoperative Anxiety and Information Scale scores in operating rooms

    Time frame: two months

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

    Time frame: two months

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Study locations

1 of 1 sites recruiting
  • Mengucek Gazi Training and Research Hospital
    Erzincan, Merkez 24100, Turkey
    Recruiting
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References and documents

Publications

  • 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. PubMed 19295391 ↗
  • 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. PubMed 8623940 ↗
  • 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. PubMed 11493233 ↗
  • 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. PubMed 8298547 ↗
  • 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. PubMed 2340614 ↗
  • 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. PubMed 9278833 ↗
  • 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. PubMed 9024018 ↗
  • 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. PubMed 3980747 ↗
  • 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. PubMed 4688678 ↗
  • 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. PubMed 6027959 ↗
  • Hicks JA, Jenkins JG. The measurement of preoperative anxiety. J R Soc Med. 1988 Sep;81(9):517-9. doi: 10.1177/014107688808100907. PubMed 3184108 ↗
  • Johnston M. Anxiety in surgical patients. Psychol Med. 1980 Feb;10(1):145-52. doi: 10.1017/s0033291700039684. PubMed 7384316 ↗
  • 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. PubMed 25948900 ↗
  • 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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02511210
Lead sponsor
Cukurova University
Collaborators
Erzincan University
Responsible party
ILKE KUPELI (M.D, Cukurova University) — Principal investigator
First posted
Jul 29, 2015
Start date
Jun 2015
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Dec 29, 2015

Study contacts

ILKE KUPELI, M.D
Contact
ilkeser2004@gmail.com
+905555485632
ILKE KUPELI, M.D
principal investigator · Erzincan University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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