Educational Video and Peri-operative Anxiety

NCT03581097 | Completed Results

• 1 other identifier: CERU-1801
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Preoperative anxiety is a common problem with an impact on surgical outcome, anaesthetic drug dosage and patient's satisfaction. An important component of preoperative anxiety is due to concerns related to anaesthesia. Appropriate patients information has been shown to reduce preoperative anxiety level and this can be effectively achieved through a video. The aim of this study is to assess the impact of an informative video about the anaesthesia technique on patient's preoperative anxiety levels before minor ambulatory procedures. 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.

Conditions

Ambulatory Surgical Procedures; Anxiety Disorders

Keywords

Anxiety disorders; hand surgery; Educational Video

Outcome Measures

Primary Outcomes (1)

• VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)

  Primary outcome measure is to see and analyze any difference in preoperative anxiety between the video and control group, measured on our Adapted Visual Analogue Scale (VAS-A). Scale range is 0 to 5, where 0 means no anxiety, while 5 means maximal anxiety. 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 regional anesthesia.

  2 hours

Secondary Outcomes (7)

• Degree of Satisfaction

  3 hours

• Vital Parameters 1: Arterial Blood Pressure

  2 hours

• Vital Parameters 2: Respiratory Rate

  2 hours

• Vital Parameters 3: Heart Rate

  2 hours

• First Subgroups Analyze: Anxious Patients

  2 hours

Study Arms (2)

Video Group

EXPERIMENTAL

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

Other: Video Group

Control Group

NO INTERVENTION

Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.

Interventions

Video Group OTHER

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)

Video Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients older than 18 years,
• American Society Anesthesiology (ASA) score I-III patients
• patients undergoing elective hand-surgery operation
• patients anesthetized by IntraVenous Regional Anesthesia (IVRA)

You may not qualify if:

• patient refusal,
• on-going anxiolytic or anti-depressive therapy,
• diagnosis of anxiety or psychiatric disorders,
• general contraindications to IVRA,
• limited compliance
• language barriers

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Andrea Saporito MD

Bellinzona, 6500, Switzerland

Location

Related Publications (22)

• 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.

  PMID: 11207465 BACKGROUND

• 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.

  PMID: 21149288 BACKGROUND

• 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.

  PMID: 16250712 BACKGROUND

• 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.

  PMID: 16698416 BACKGROUND

• 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.

  PMID: 9717776 BACKGROUND

• 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.

  PMID: 4634747 BACKGROUND

• 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.

  PMID: 16959466 BACKGROUND

• 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.

  PMID: 15793639 BACKGROUND

• 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.

  PMID: 23161296 RESULT

• 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.

  PMID: 12209483 RESULT

• 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.

  PMID: 2340614 RESULT

• 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.

  PMID: 15780234 RESULT

• 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.

  PMID: 21342392 RESULT

• 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.

  PMID: 22464659 RESULT

• 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.

  PMID: 24180719 RESULT

• 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.

  PMID: 15727280 RESULT

• 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.

  PMID: 2792117 RESULT

• 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.

  PMID: 20124283 RESULT

• 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.

  PMID: 14679325 RESULT

• 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.

  PMID: 10702461 RESULT

• 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.

  PMID: 15615737 RESULT

• 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.

  PMID: 17286194 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Limitations and Caveats

* Authors adopted the VAS score. * Type of surgery has been shown to influence anxiety levels. * The study was not adequately powered to assess statistical significance of these secondary outcomes.

Results Point of Contact

• Title: Dr. med. Andrea Saporito, Vice-Chair Department of Anesthesia
• Organization: Ospedale Regionale di Bellinzona e Valli (ORBV)

andrea.saporito@eoc.ch

091/811.91.11

Study Officials

• Cesare Fusetti, MD

  Ente Ospedaliero Cantonale, Bellinzona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Surgeon and investigators involved in subsequent data analysis were blinded to group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Model Details: Retrospective, single centre, case-control trial

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 10, 2018
• Study Start: February 1, 2013
• Primary Completion: May 30, 2013
• Study Completion: June 10, 2018
• Last Updated: September 13, 2019
• Results First Posted: September 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)