Anxiety DisordersNCT02511210
Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety
A study testing regional anesthesia and general anesthesia in people with Anxiety Disorders, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- regional anesthesia and general anesthesia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 80,
- both women and men,
- Patients will be operated
Who cannot join
- psychiatric and neurologic diseases,
- hearing and speech disorders,
- Psychiatric drug and chronic alcohol use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mengucek Gazi Training and Research Hospital
Erzincan, Merkez, 24100
ILKE KUPELI, M.D, +905555485632, ilkeser2004@gmail.com
About this study
Official title: 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.
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.
- Conditions
- Anxiety Disorders
- Being tested
- regional anesthesia, general anesthesia
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional anesthesiaBehavioural
preoperative anxiety
general anesthesiaBehavioural
preoperative anxiety
| Study group | Role | What they receive |
|---|---|---|
| regional anesthesia | Active comparator | spinal anesthesia or peripheral nerve block Receives: Behavioral: regional anesthesia |
| general anesthesia | Active comparator | intubated patients Receives: Behavioral: general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia
Measured: two months
Secondary outcomes (3)
State-Trait Anxiety Inventory scores in operating rooms
Measured: two months
Amsterdam Preoperative Anxiety and Information Scale scores in operating rooms
Measured: two months
Amsterdam Preoperative Anxiety and Information Scale scores in patients undergoing regional anesthesia
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- Erzincan University
- Responsible party
- Principal investigator, ILKE KUPELI, Cukurova University
- Investigators
- ILKE KUPELI, M.D, Principal investigator, Erzincan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511210
- Sponsor's protocol ID
- erzincan university
- Status last verified
- Sep 2015
- First submitted
- 24 Jul 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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 19295391Moerman 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 8623940Caumo 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 11493233Markland 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 8298547Badner 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 2340614Kain 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 9278833Kain 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 9024018Tenenbaum 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 3980747Spielberger 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 4688678Norris 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 6027959Hicks JA, Jenkins JG. The measurement of preoperative anxiety. J R Soc Med. 1988 Sep;81(9):517-9. doi: 10.1177/014107688808100907.
PubMed 3184108Johnston M. Anxiety in surgical patients. Psychol Med. 1980 Feb;10(1):145-52. doi: 10.1017/s0033291700039684.
PubMed 7384316Maheshwari 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 25948900Deniz 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 at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Regional Anesthesia / Peripheral Nerve Block and General Anesthesia on Preoperative Anxiety
- ClinicalTrials.gov ID
- NCT02511210
- Acronym / sponsor ID
- erzincan university
- Conditions
- Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- Erzincan University
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regional anesthesia | Active comparator | Behavioral: regional anesthesiaspinal anesthesia or peripheral nerve block |
| general anesthesia | Active comparator | Behavioral: general anesthesiaintubated patients |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 80,
- both women and men,
- Patients will be operated
Key exclusion criteria (3 listed)
- psychiatric and neurologic diseases,
- hearing and speech disorders,
- Psychiatric drug and chronic alcohol use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regional anesthesiapreoperative anxiety | Behavioural | regional anesthesia |
| general anesthesiapreoperative anxiety | Behavioural | general anesthesia |
Primary outcome
State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia
Time frame: two months
3 secondary outcomes
State-Trait Anxiety Inventory scores in operating rooms
Time frame: two months
Amsterdam Preoperative Anxiety and Information Scale scores in operating rooms
Time frame: two months
Amsterdam Preoperative Anxiety and Information Scale scores in patients undergoing regional anesthesia
Time frame: two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
- Background: PubMed 19295391Perks A, Chakravarti S, Manninen P. Preoperative anxiety in neurosurgical patients. J Neurosurg Anesthesiol. 2009 Apr;21(2):127-30. doi: 10.1097/ANA.0b013e31819a6ca3.
- Background: PubMed 8623940Moerman 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.
- Background: PubMed 11493233Caumo 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.
- Background: PubMed 8298547Markland 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.
- Background: PubMed 2340614Badner 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.
- Background: PubMed 9278833Kain 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.
- Background: PubMed 9024018Kain 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.
- Background: PubMed 3980747Tenenbaum 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 publication: PubMed 4688678Spielberger 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 publication: PubMed 6027959Norris 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 publication: PubMed 3184108Hicks JA, Jenkins JG. The measurement of preoperative anxiety. J R Soc Med. 1988 Sep;81(9):517-9. doi: 10.1177/014107688808100907.
- Results publication: PubMed 7384316Johnston M. Anxiety in surgical patients. Psychol Med. 1980 Feb;10(1):145-52. doi: 10.1017/s0033291700039684.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ILKE KUPELI, M.D principal investigator
Erzincan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regional anesthesia and general anesthesia in people with Anxiety Disorders, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ILKE KUPELI, M.D (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory scores in patients undergoing regional anesthesia (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02511210, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.