Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-28 @ 6:31 AM
Study NCT ID:
NCT04432558
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2020-06-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Effects of Preoperative Anxiety
Sponsor:
Organization:
Raw JSON
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The analgesic consumption of the patients will be recorded by evaluating the pain with Visual analog scale (VAS) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative anxiety level', 'Postoperative pain', 'Laparoscopic sleeve gastrectomy'], 'conditions': ['Anxiety', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '21857597', 'type': 'BACKGROUND', 'citation': 'Jawaid M, Mushtaq A, Mukhtar S, Khan Z. Preoperative anxiety before elective surgery. Neurosciences (Riyadh). 2007 Apr;12(2):145-8.'}, {'pmid': '26442401', 'type': 'BACKGROUND', 'citation': 'Akinsulore A, Owojuyigbe AM, Faponle AF, Fatoye FO. ASSESSMENT OF PREOPERATIVE AND POSTOPERATIVE ANXIETY AMONG ELECTIVE MAJOR SURGERY PATIENTS IN A TERTIARY HOSPITAL IN NIGERIA. Middle East J Anaesthesiol. 2015 Jun;23(2):235-40.'}, {'pmid': '21501874', 'type': 'BACKGROUND', 'citation': 'de Zwaan M, Enderle J, Wagner S, Muhlhans B, Ditzen B, Gefeller O, Mitchell JE, Muller A. Anxiety and depression in bariatric surgery patients: a prospective, follow-up study using structured clinical interviews. J Affect Disord. 2011 Sep;133(1-2):61-8. doi: 10.1016/j.jad.2011.03.025. Epub 2011 Apr 17.'}, {'pmid': '25084797', 'type': 'BACKGROUND', 'citation': 'Edwards-Hampton SA, Madan A, Wedin S, Borckardt JJ, Crowley N, Byrne KT. A closer look at the nature of anxiety in weight loss surgery candidates. Int J Psychiatry Med. 2014;47(2):105-13. doi: 10.2190/PM.47.2.b.'}, {'pmid': '23377862', 'type': 'BACKGROUND', 'citation': 'Clarke H, Kirkham KR, Orser BA, Katznelson R, Mitsakakis N, Ko R, Snyman A, Ma M, Katz J. Gabapentin reduces preoperative anxiety and pain catastrophizing in highly anxious patients prior to major surgery: a blinded randomized placebo-controlled trial. Can J Anaesth. 2013 May;60(5):432-43. doi: 10.1007/s12630-013-9890-1. Epub 2013 Feb 2.'}, {'pmid': '25493674', 'type': 'BACKGROUND', 'citation': 'Robleda G, Sillero-Sillero A, Puig T, Gich I, Banos JE. Influence of preoperative emotional state on postoperative pain following orthopedic and trauma surgery. Rev Lat Am Enfermagem. 2014 Oct;22(5):785-91. doi: 10.1590/0104-1169.0118.2481.'}, {'pmid': '26153780', 'type': 'BACKGROUND', 'citation': 'Raichle KA, Osborne TL, Jensen MP, Ehde DM, Smith DG, Robinson LR. Preoperative state anxiety, acute postoperative pain, and analgesic use in persons undergoing lower limb amputation. Clin J Pain. 2015 Aug;31(8):699-706. doi: 10.1097/AJP.0000000000000150.'}, {'pmid': '25637724', 'type': 'BACKGROUND', 'citation': 'Petrovic NM, Milovanovic DR, Ignjatovic Ristic D, Riznic N, Ristic B, Stepanovic Z. Factors associated with severe postoperative pain in patients with total hip arthroplasty. Acta Orthop Traumatol Turc. 2014;48(6):615-22. doi: 10.3944/AOTT.2014.14.0177.'}, {'pmid': '24077858', 'type': 'BACKGROUND', 'citation': 'Ali A, Altun D, Oguz BH, Ilhan M, Demircan F, Koltka K. The effect of preoperative anxiety on postoperative analgesia and anesthesia recovery in patients undergoing laparascopic cholecystectomy. J Anesth. 2014 Apr;28(2):222-7. doi: 10.1007/s00540-013-1712-7. No abstract available.'}, {'pmid': '26499321', 'type': 'BACKGROUND', 'citation': 'Aouad MT, Kanazi GE, Malek K, Tamim H, Zahreddine L, Kaddoum RN. Predictors of postoperative pain and analgesic requirements following abdominal hysterectomy: an observational study. J Anesth. 2016 Feb;30(1):72-9. doi: 10.1007/s00540-015-2090-0. Epub 2015 Oct 24.'}, {'pmid': '27551421', 'type': 'BACKGROUND', 'citation': 'Bradshaw P, Hariharan S, Chen D. Does preoperative psychological status of patients affect postoperative pain? A prospective study from the Caribbean. Br J Pain. 2016 May;10(2):108-15. doi: 10.1177/2049463716635680. Epub 2016 Mar 2.'}, {'pmid': '18496304', 'type': 'BACKGROUND', 'citation': 'De Cosmo G, Congedo E, Lai C, Primieri P, Dottarelli A, Aceto P. Preoperative psychologic and demographic predictors of pain perception and tramadol consumption using intravenous patient-controlled analgesia. Clin J Pain. 2008 Jun;24(5):399-405. doi: 10.1097/AJP.0b013e3181671a08.'}, {'pmid': '11182434', 'type': 'BACKGROUND', 'citation': 'Kain ZN, Sevarino F, Alexander GM, Pincus S, Mayes LC. Preoperative anxiety and postoperative pain in women undergoing hysterectomy. A repeated-measures design. J Psychosom Res. 2000 Dec;49(6):417-22. doi: 10.1016/s0022-3999(00)00189-6.'}, {'pmid': '15129613', 'type': 'BACKGROUND', 'citation': 'Polomano RC, Heffner SM, Reck DL, Gelnett CM, French D. Evidence for opioid variability, Part 2: Psychosocial influences. Semin Perioper Nurs. 2001 Oct;10(4):159-66.'}, {'pmid': '12133084', 'type': 'BACKGROUND', 'citation': 'Caumo W, Hidalgo MP, Schmidt AP, Iwamoto CW, Adamatti LC, Bergmann J, Ferreira MB. Effect of pre-operative anxiolysis on postoperative pain response in patients undergoing total abdominal hysterectomy. Anaesthesia. 2002 Aug;57(8):740-6. doi: 10.1046/j.1365-2044.2002.02690.x.'}, {'pmid': '12492793', 'type': 'BACKGROUND', 'citation': 'Ozalp G, Sarioglu R, Tuncel G, Aslan K, Kadiogullari N. Preoperative emotional states in patients with breast cancer and postoperative pain. Acta Anaesthesiol Scand. 2003 Jan;47(1):26-9. doi: 10.1034/j.1399-6576.2003.470105.x.'}, {'pmid': '15474849', 'type': 'BACKGROUND', 'citation': 'Feeney SL. The relationship between pain and negative affect in older adults: anxiety as a predictor of pain. J Anxiety Disord. 2004;18(6):733-44. doi: 10.1016/j.janxdis.2001.04.001.'}, {'pmid': '14527702', 'type': 'BACKGROUND', 'citation': 'Kalkman JC, Visser K, Moen J, Bonsel JG, Grobbee ED, Moons MKG. Preoperative prediction of severe postoperative pain. Pain. 2003 Oct;105(3):415-423. doi: 10.1016/S0304-3959(03)00252-5.'}, {'pmid': '25995061', 'type': 'BACKGROUND', 'citation': 'Hashimoto K, Iwayama S, Sano Y, Tatara T, Hirose M. Preoperative anxiety induces no clinically relevant effect on intraoperative nociceptive levels during breast surgery under general anesthesia. J Anesth. 2015 Dec;29(6):967-70. doi: 10.1007/s00540-015-2032-x. Epub 2015 May 21.'}, {'pmid': '14614791', 'type': 'BACKGROUND', 'citation': 'Munafo MR, Stevenson J. Selective processing of threat-related cues in day surgery patients and prediction of post-operative pain. Br J Health Psychol. 2003 Nov;8(Pt 4):439-49. doi: 10.1348/135910703770238293.'}, {'pmid': '11374599', 'type': 'BACKGROUND', 'citation': 'Kain ZN, Sevarino FB, Rinder C, Pincus S, Alexander GM, Ivy M, Heninger G. Preoperative anxiolysis and postoperative recovery in women undergoing abdominal hysterectomy. Anesthesiology. 2001 Mar;94(3):415-22. doi: 10.1097/00000542-200103000-00009.'}, {'pmid': '12194547', 'type': 'BACKGROUND', 'citation': 'Papageorgiou GM, Papakonstantinou A, Mamplekou E, Terzis I, Melissas J. Pre- and postoperative psychological characteristics in morbidly obese patients. Obes Surg. 2002 Aug;12(4):534-9. doi: 10.1381/096089202762252307.'}, {'pmid': '20508787', 'type': 'BACKGROUND', 'citation': 'Kim WS, Byeon GJ, Song BJ, Lee HJ. Availability of preoperative anxiety scale as a predictive factor for hemodynamic changes during induction of anesthesia. Korean J Anesthesiol. 2010 Apr;58(4):328-33. doi: 10.4097/kjae.2010.58.4.328. Epub 2010 Apr 28.'}, {'type': 'BACKGROUND', 'citation': '25. Öner N, Le Compte A. Durumluk-Sürekli Kaygı Envanteri El Kitabı, 1. Baskı, İstanbul, Boğaziçi Üniversitesi Yayınları, 1983; 1-26.'}, {'pmid': '7772368', 'type': 'BACKGROUND', 'citation': 'Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995 Feb;7(1):89-91. doi: 10.1016/0952-8180(94)00001-k. No abstract available.'}, {'pmid': '4835444', 'type': 'BACKGROUND', 'citation': 'Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9. doi: 10.1136/bmj.2.5920.656.'}, {'type': 'BACKGROUND', 'citation': '28. Karaman S, Dogru S, Karaman T, Tapar H, Sahin A, Arici S, Kaya Z, Suren M. Anesthesia management in laparoscopic bariatric surgery: Perioperative complications and outcomes in the third year of practice. JCEI 2014; 5: 200-5.'}, {'pmid': '17352896', 'type': 'BACKGROUND', 'citation': 'Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6.'}]}, 'descriptionModule': {'briefSummary': "INTRODUCTION Patients who will have obesity surgery have about %48 psychiatric illnesses like anxiety disorder. Studies which analyze the relationship between preoperative anxiety level and postoperative pain had reported conflicting results. The aim of this study is to search the relationship between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy surgery.\n\nMATERIAL AND METHODS Our prospective double-blind study is planned to require 86 female patients aged between 18-65 years old, American Society of Anesthesiologists (ASA) I-II and Body mass index (BMI) ≥40 kg/m\\^2. Patients having a psychiatric or neurologic disease, brain damage, using psychiatric medications (antidepressants, anxiolytics) and chronic alcohol, known allergy to medications used in the study protocol, inability to provide informed consent will be excluded. Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery. The analgesic consumption of the patients will be recorded by evaluating the pain with Visual analog scale (VAS) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.\n\nEXPECTATIONS AND SCIENTIFIC CONTRIBUTIONS More satisfying postoperative analgesia may be provided in this group of patients by determining correlation between preoperative anxiety level and postoperative pain and analgesic consumption in patients who had laparoscopic sleeve gastrectomy. Morbidity rate related with pain may be decreased and patient satisfaction may be increased."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Female patients aged between 18-65 years old, ASA I-II, which BMI ≥35 kg/m\\^2 and have bariatric surgical indications because of morbid (type III) obesity', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged between 18-65 years old\n* ASA I-II\n* BMI ≥35 kg/m\\^2\n\nExclusion Criteria:\n\n* Having a psychiatric or neurologic disease\n* Brain damage\n* Using psychiatric medications (antidepressants, anxiolytics) and chronic alcohol\n* Known allergy to medications used in the study protocol'}, 'identificationModule': {'nctId': 'NCT04432558', 'briefTitle': 'Postoperative Effects of Preoperative Anxiety', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'The Effect of Preoperative Anxiety Level to Postoperative Pain and Analgesic Consumption in Patients Who Had Laparoscopic Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': 'K17/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preoperative anxiety level', 'interventionNames': ["Diagnostic Test: Spielberger's State-Trait Anxiety Inventory"]}, {'label': 'Postoperative pain and analgesic consumption', 'interventionNames': ["Other: Visual analog scale, Ramsay's sedation scale", 'Drug: Tramadol, paracetamol, diclofenac sodium']}], 'interventions': [{'name': "Spielberger's State-Trait Anxiety Inventory", 'type': 'DIAGNOSTIC_TEST', 'description': "Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery.", 'armGroupLabels': ['Preoperative anxiety level']}, {'name': "Visual analog scale, Ramsay's sedation scale", 'type': 'OTHER', 'description': "The analgesic consumption of the patients will be recorded by evaluating the pain with VAS (Visual analog scale) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.", 'armGroupLabels': ['Postoperative pain and analgesic consumption']}, {'name': 'Tramadol, paracetamol, diclofenac sodium', 'type': 'DRUG', 'description': 'The analgesic consumption of the patients will be recorded', 'armGroupLabels': ['Postoperative pain and analgesic consumption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35540', 'city': 'Izmir', 'state': 'Karşıyaka', 'country': 'Turkey (Türkiye)', 'facility': 'Baskent University Zubeyde Hanim Practice and Research Center', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor. Anaesthesia and reanimation specialist', 'investigatorFullName': 'Yonca Özvardar Pekcan', 'investigatorAffiliation': 'Baskent University'}}}}