Study Results
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View full resultsBasic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2013-02-01
2018-06-10
Brief Summary
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The study design is a prospective, randomized, controlled clinical trial, where we use of short patient educational video to reduce preoperative anxiety level, explaining all sequence of major events between the arrival in the operating room and the performance of anaesthesia.
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Detailed Description
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Patients' satisfaction is largely based on their expectations and it forms part of the surgeon's reward: satisfied patients are more likely to maintain a good relationship with the surgeon, abstain from so called "doctor shopping", avoid malpractice litigations and recommend their surgeon to others. Last but not least, satisfied patients are more likely to comply with postoperative prescriptions and attend follow-up appointments. In non-life threatening procedures however, the main source of preoperative anxiety is often the outlook of anaesthesia rather than surgery itself, this being mainly related to a lack of enough information about the anaesthetic procedure. These fears are largely underestimated in routine minor procedures (such as ambulatory surgery) and thus risk to be not properly addressed. Due to lack of time and resources, this could have a significant impact on global patient satisfaction. Also if major complications (e.g. cardiac mortality) are surgery-related, anxiety is also associated with poor surgical outcome. How to identify and treat patients who will likely benefit from more information about anaesthesia is an important question that remains relatively unaddressed. However, it's known that more information about surgery reduces the level of anxiety and apprehension.
Some strategies have been developed to try to reduce pre-operative stress: deliver clinical information has proven to be able to relieve patient anxiety. Written information has recognised useful, but not all patients have shown the same degree of culture needed to read and understand texts. The use of multimedia information (such as videos) has already been studied and some trials have shown a certain anxiolytic effect, but data are conflicting. A part of this disparity probably derives from differences in methodology and culture between patients.
For these reasons the investigators developed a trial using a short educational video about the global management of local anaesthesia on outpatient hand surgery. The aim of this study is to assess the impact of this educational video about perioperative patient's anxiety levels.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Video Group
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of intravenous regional anesthesia
Video Group
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of Intra-Venous Regional Anesthesia (IVRA)
Control Group
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
No interventions assigned to this group
Interventions
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Video Group
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of Intra-Venous Regional Anesthesia (IVRA)
Eligibility Criteria
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Inclusion Criteria
* American Society Anesthesiology (ASA) score I-III patients
* patients undergoing elective hand-surgery operation
* patients anesthetized by IntraVenous Regional Anesthesia (IVRA)
Exclusion Criteria
* on-going anxiolytic or anti-depressive therapy,
* diagnosis of anxiety or psychiatric disorders,
* general contraindications to IVRA,
* limited compliance
* language barriers
18 Years
ALL
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Samuele Ceruti
Dr. med.
Principal Investigators
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Cesare Fusetti, MD
Role: PRINCIPAL_INVESTIGATOR
Ente Ospedaliero Cantonale, Bellinzona
Locations
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Andrea Saporito MD
Bellinzona, , Switzerland
Countries
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References
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Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Bandeira D, Ferreira MB. Risk factors for preoperative anxiety in adults. Acta Anaesthesiol Scand. 2001 Mar;45(3):298-307. doi: 10.1034/j.1399-6576.2001.045003298.x.
Edward GM, v d Naald N, Oort FJ, de Haes HC, Biervliet JD, Hollmann MW, Preckel B. Information gain in patients using a multimedia website with tailored information on anaesthesia. Br J Anaesth. 2011 Mar;106(3):319-24. doi: 10.1093/bja/aeq360. Epub 2010 Dec 10.
Grossi G, Perski A, Feleke E, Jakobson U. State anxiety predicts poor psychosocial outcome after coronary bypass surgery. Int J Behav Med. 1998;5(1):1-16. doi: 10.1207/s15327558ijbm0501_1.
Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
Morgan J, Roufeil L, Kaushik S, Bassett M. Influence of coping style and precolonoscopy information on pain and anxiety of colonoscopy. Gastrointest Endosc. 1998 Aug;48(2):119-27. doi: 10.1016/s0016-5107(98)70152-x.
Ramsay MA. A survey of pre-operative fear. Anaesthesia. 1972 Oct;27(4):396-402. doi: 10.1111/j.1365-2044.1972.tb08244.x. No abstract available.
Sorlie T, Busund R, Sexton J, Sexton H, Sorlie D. Video information combined with individualized information sessions: Effects upon emotional well-being following coronary artery bypass surgery--A randomized trial. Patient Educ Couns. 2007 Feb;65(2):180-8. doi: 10.1016/j.pec.2006.07.006. Epub 2006 Sep 7.
Takahashi Y, Tanaka H, Kinjo M, Sakumoto K. Prospective evaluation of factors predicting difficulty and pain during sedation-free colonoscopy. Dis Colon Rectum. 2005 Jun;48(6):1295-300. doi: 10.1007/s10350-004-0940-1.
Arabul M, Kandemir A, Celik M, Alper E, Akpinar Z, Aslan F, Vatansever S, Unsal B. Impact of an information video before colonoscopy on patient satisfaction and anxiety. Turk J Gastroenterol. 2012;23(5):523-9. doi: 10.4318/tjg.2012.0416.
Ayral X, Gicquere C, Duhalde A, Boucheny D, Dougados M. Effects of video information on preoperative anxiety level and tolerability of joint lavage in knee osteoarthritis. Arthritis Rheum. 2002 Aug;47(4):380-2. doi: 10.1002/art.10559.
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.
Danino AM, Chahraoui K, Frachebois L, Jebrane A, Moutel G, Herve C, Malka G. Effects of an informational CD-ROM on anxiety and knowledge before aesthetic surgery: a randomised trial. Br J Plast Surg. 2005 Apr;58(3):379-83. doi: 10.1016/j.bjps.2004.10.020.
Cornoiu A, Beischer AD, Donnan L, Graves S, de Steiger R. Multimedia patient education to assist the informed consent process for knee arthroscopy. ANZ J Surg. 2011 Mar;81(3):176-80. doi: 10.1111/j.1445-2197.2010.05487.x. Epub 2010 Oct 1.
Crabtree TD, Puri V, Bell JM, Bontumasi N, Patterson GA, Kreisel D, Krupnick AS, Meyers BF. Outcomes and perception of lung surgery with implementation of a patient video education module: a prospective cohort study. J Am Coll Surg. 2012 May;214(5):816-21.e2. doi: 10.1016/j.jamcollsurg.2012.01.047. Epub 2012 Mar 28.
Eley VA, Searles T, Donovan K, Walters E. Effect of an anaesthesia information video on preoperative maternal anxiety and postoperative satisfaction in elective caesarean section: a prospective randomised trial. Anaesth Intensive Care. 2013 Nov;41(6):774-81. doi: 10.1177/0310057X1304100613.
Hering K, Harvan J, Dangelo M, Jasinski D. The use of a computer website prior to scheduled surgery (a pilot study): impact on patient information, acquisition, anxiety level, and overall satisfaction with anesthesia care. AANA J. 2005 Feb;73(1):29-33.
Herrmann KS, Kreuzer H. A randomized prospective study on anxiety reduction by preparatory disclosure with and without video film show about a planned heart catheterization. Eur Heart J. 1989 Aug;10(8):753-7. doi: 10.1093/oxfordjournals.eurheartj.a059560.
Jlala HA, French JL, Foxall GL, Hardman JG, Bedforth NM. Effect of preoperative multimedia information on perioperative anxiety in patients undergoing procedures under regional anaesthesia. Br J Anaesth. 2010 Mar;104(3):369-74. doi: 10.1093/bja/aeq002. Epub 2010 Feb 1.
Jones MP, Ebert CC, Sloan T, Spanier J, Bansal A, Howden CW, Vanagunas AD. Patient anxiety and elective gastrointestinal endoscopy. J Clin Gastroenterol. 2004 Jan;38(1):35-40. doi: 10.1097/00004836-200401000-00009.
Kindler CH, Harms C, Amsler F, Ihde-Scholl T, Scheidegger D. The visual analog scale allows effective measurement of preoperative anxiety and detection of patients' anesthetic concerns. Anesth Analg. 2000 Mar;90(3):706-12. doi: 10.1097/00000539-200003000-00036.
Pager CK. Randomised controlled trial of preoperative information to improve satisfaction with cataract surgery. Br J Ophthalmol. 2005 Jan;89(1):10-3. doi: 10.1136/bjo.2004.048637.
Zieren J, Menenakos C, Mueller JM. Does an informative video before inguinal hernia surgical repair influence postoperative quality of life? Results of a prospective randomized study. Qual Life Res. 2007 Jun;16(5):725-9. doi: 10.1007/s11136-007-9171-y. Epub 2007 Feb 8.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CERU-1801
Identifier Type: -
Identifier Source: org_study_id
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