The Effect of Informational Videos on Preoperative Anxiety and Satisfaction Levels in Patients Undergoing Elective Ambulatory Surgery. A Case-control Clinical Trial
Phase: NA
Conditions: Ambulatory Surgical Procedures, Anxiety Disorders
Sponsor: University Hospital, Geneva

s w i s s e t h i c s  
Schweizerische Ethikkommissionen für die Forschung am Menschen 
Commissions d’éthique suisses relative à la recherche sur l'être humain 
Commissioni etiche svizzere per la ricerca sull'essere umano 
Swiss Ethics Committees on research involving humans 
 
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Sponsor/Sponsor-
Investigator 
Ente Ospedaliero Cantonale 
Study Title: 
The effect of informational videos on preoperative anxiety and satisfaction 
levels in patients undergoing elective ambulatory surgery. A prospective, 
randomized, controlled clinical trial. 
Short Title/Study ID: 
CERU-1801 
Protocol Version and 
Date: 
Version 1.1   
Trial Registration: 
www.clinicaltrials.gov NCT03581097 
Study Category with 
Rationale 
Provide the determined study category with explanation for this category 
Background and 
Rationale: 
Anxiety is a common disorder in patients undergoing invasive procedures, 
reaching up to 60-80% in some series of these patients. Perioperative 
anxiety is associated with hemodynamic effects (like arterial hypertension 
and arrhythmias); it can have an impact on final surgical outcome, on 
anaesthetics drug dosage and also on rising of post-operative pain 
perception, leading to a substantial amount of analgesics prescription and 
post-operative hospitalization days. Finally, perioperative anxiety can 
reduce patient's overall satisfaction about quality of perioperative care. 
 
Perioperative satisfaction is largely based on patients’ expectations; it 
forms part of the surgeon’s reward: satisfied patients are more likely to 
maintain good relationships with the surgeon, to abstain from the so-
called “doctor shopping”, to avoid malpractice proceedings and to 
recommend own surgeon to others. Last but not least, satisfied patients 
are more likely have better compliance about postoperative prescriptions 
and to attend follow-up appointments. In not life-threatening procedures 
however, main source of preoperative anxiety is often the anaesthesia 
outlook rather than surgery itself, largely related to a lack of information 
about anaesthetic procedure. These fears are largely underestimated in 
routine minor procedures (such as ambulatory surgery) and therefore real 
risk is not properly addressed. Due to lack of time and resources, this 
could have a significant impact on global patient satisfaction. Also if major 
complications are surgery-related (e.g. cardiac mortality), 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 

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known that more information about surgery reduces the level of anxiety 
and apprehension. 
Objective(s): 
For these reasons we developed this study with a short educational video 
concerning global management of local anaesthesia on outpatient hand 
surgery. The aim of this trial was to assess the impact of this educational 
video about perioperative patients’ anxiety levels. 
Outcome (if 
applicable, see 
Basisformular): 
Primary Outcome 
Secondary Outcome 
The principal outcome was to see and analyse the difference in 
preoperative anxiety between the two groups measured on our adapted 
visual analogue scale (VAS-A). Secondary outcomes were to perceive 
any disparity in patient’s satisfaction degree measured through final 
questionnaire, and any variance in vital parameters that are usually 
affected by anxiety (like arterial blood pressure [mmHg], respiratory rate 
[breath per minute] and heart rate [beat per minute]) in all patients. A 
subgroup analysis was than performed, but applied to specific subgroups, 
like anxious patients, higher anxiety score (3 or more) and patients at their 
first experience with surgery. 
Study Design, see 
Basisformular: 
This is a prospective, randomized, controlled clinical trial. 
Inclusion/Exclusion 
Criteria, see 
Basisformular: 
Inclusion criteria were patients older than 18 years, ASA I-III patients 
undergoing elective hand-surgery operation and patients anesthetized by 
IVRA. Exclusion criteria were patient refusal, on-going anxiolytic or anti-
depressive therapy, diagnosis of anxiety or psychiatric disorders, general 
contraindications to IVRA, limited compliance or language barriers. 
Measurements and 
Procedures: 
Patients were admitted on the same day of surgery in the day-hospital 
clinic, 2-3 hours before the operation; all vital parameters (non-invasive 
arterial blood pressure, respiratory and heart rate) were measured and 
they were asked to indicate their initial level of anxiety using some 
validated instrument, like the VAS-scale (discussed right below). Patients 
were randomized with a free web tool (available at www.randomizer.org) 
in a consecutive order into two parallels groups; last Author was the 
responsible of this randomisation and he was not directly involved in 
patient treatment. Surgeon and investigators involved in subsequent data 
analysis were blinded to group assignment. 
Study 
Product/Intervention 
according to KlinV, if 
applicable: 
One hour before surgery, patients assigned to the video-group (group I) 
visualised a Patient Education Video, a brief video (6 minutes). Patients in 
the film group watched the movie using a laptop computer equipped with 
headphones, and VAS score (Visual Analogue Scale) was repeated after 
the film. 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 anaesthesia. The video 
began with an actress interpreting a patient scheduled for an elective 
outpatient hand surgery procedure acceding the day hospital clinic. It 
showed the interaction between the patient and the nurses who explain in 
details what is going to happen next and lead her through the preparation 
routine. The camera then followed the patient as she is accompanied to 
the induction room and the video showed all the details of the checks 
made as the patient accedes the operating room, the time-out and the 
preparation for the anaesthetic procedure, with the monitoring of the vital 
parameters. Than the intra-venous regional anaesthesia procedure was 
shown in details as an anaesthesiologist explains it step by step. The 
video concluded with the patient being brought to the operating room and 
staying awake and pain free as a simulated procedure begins. 
Comparator(s) (if 
applicable): 
Patients assigned to the control group (group II) did not see the video and 
underwent an otherwise identical preoperative preparation procedure. 
Study Duration: 
Around 8-9 months 

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Study Schedule: 
From April to December 2013 
Investigator(s): 
1. Dr. med. Fusetti Cesare  
Medico Aggiunto, Dip. Chirurgia della Mano ORBV, Bellinzona 
 
2. Dr. med. Musiari Michele 
Medico Assistente, Serv. Anestesia ORBV, Bellinzona 
 
3. Dr. med. Ceruti Samuele 
CapoClinica Medicina Intensiva, HUG, Geneva  
 
4. Dr. med. Cafarotti Stefano 
VicePrimario Chirurgia Toracica, ORBV Bellinzona 
 
5. Dr. med. La Regina Davide 
VicePrimario Chirurgia Generale, ORBV Bellinzona  
 
6. Dr. med. Saporito Andrea 
VicePrimario Serv. Anestesia e Rianimazione ORBV, Bellinzona 
Study Centre(s): 
This is a single-centre study, to ORBV, Bellinzona 
Statistical Analysis 
incl. Power Analysis 
A power analysis was conducted before starting recruitment. According to 
Ayral et al, as well according to estimated clinically relevance of 
diminution for anxiety, assuming a reduction of at least 50% in 
preoperative anxiety level as clinically significant, 45 patients per group 
were necessary (allowing for drop-outs) to reach a 95% level of 
significance with a power of 90%. We conducted a statistical frequency 
analysis regarding common vitals parameters and anxiety level according 
to VAS-scale at arrival in the hospital, before to go to the pre-operative 
room and at arrival at the pre-operative room, performing a statistical 
frequency analysis comparing all these three steps and all subgroup 
according to secondary outcomes.  
GCP Statement: 
This study will be conducted in compliance with the protocol, the current 
version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as 
far as applicable) as well as all national legal and regulatory requirements.  
 
Recruitment Procedure (if applicable: Advice/Flyer have to be submitted ; if applicable, please 
indicate the Localisation / Medium (which Newspaper) 
All patients underwent two surgical pre-operative visits, during which they received detailed 
information about surgical procedure and provided their informed consent. 
 
Study Procedure/Flowchart with Timelines: Study specific Examinations have to be clearly 
identified 
Patients were randomized with a free web tool (available at www.randomizer.org) in a consecutive 
order into two parallels groups; last Author was the responsible of this randomisation and he was not 
directly involved in patient treatment. Surgeon and investigators involved in subsequent data analysis 
were blinded to group assignment. One hour before surgery, patients assigned to the video-group 
(group I) visualised a Patient Education Video, a brief video (6 minutes) better described below. 
Patients assigned to the control group (group II) did not see the video and underwent an otherwise 
identical preoperative preparation procedure. Patients assigned to the two different groups were kept 
always separated while waiting for surgery. 
 
After the end of the video and at least 30 minutes before the transfer to the operating room (OR), 
investigators asked patient to indicate again its own anxiety level. Non-invasive arterial blood 
pressure, cardiac and respiratory frequency were recorded once again on arrival in the OR and 
monitored continuously throughout the anaesthetic and surgical procedure. 
 

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IVRA was performed by an anaesthesiologist and a nurse in the induction room outside the OR using 
a standardized procedure. Two intravenous lines were placed on each hand; after tourniquet inflation, 
a total volume of 40 ml of chloroprocaine 0.5% was injected intravenously in the operated limb. The 
patient was then transferred to the OR and 10 minutes after local anaesthetic injection, the surgeon 
tested loss of sensitivity with a pinprick test, after which surgery began. 
 
As anxiety is a highly subjective psychiatric disorder, according to other investigational groups we felt 
that the best way to determine the state of anxiety is to let it evaluate directly by the patient. The VAS 
score (Visual Analogue Scale) is a valid instrument used for measuring anxiety. We chose an adapted 
VAS score (VAS-A), a semi-quantitative numerical scale (0 – 5 level) to measure patients’ anxiety 
level, asking each patient to subjectively quantify its own anxiety, putting a mark on this visual scale, 
representing its actual anxiety degree.  
 
At the end of the surgical procedure all patients were transferred directly to the day-hospital clinic. 
Between 1 - 3 hours after the operation all patients completed a satisfaction questionnaire with close 
evaluation from 0 to 10 regarding these topics: environment, equipment, organization, waiting time, 
pharmacy, nurses, professionalism, information, dedicated time. Moreover, video-group patients 
received a specific feedback questionnaire about the video, in which they were asked about personal 
satisfaction and video’s education value (like informative and a valuable source of information for 
patients before local anaesthesia). Finally, we asked them if the educational movie made them more 
anxious or calmer. 
Risks/ Inconveniences, which are Study specific:  
No risk, because the intervention is a movie of 6 minutes. 
Coverage of Damages: Insurance (yes/no)? Sum? 
No 
Storage 
of 
Data-and 
Samples 
for 
Future 
Research 
Aims: 
yes/no?,  
All data were registered and stored in a specific and protected archive in Anaesthesia Department, 
accessible only by first and last Author. These data won’t be used for further studies. 
 
The most relevant References:  
1. Johnston M. Anxiety in surgical patients. Psychol Med 1980;10:145–52   
2. Domar AD, Everett LL, Keller MG. Preoperative anxiety: is it a predictable entity? Anesth Analg 
1989;69:763–7   
3. Badner NH, Nielson WR, Munk S, Kwiatkowska C, Gelb AW. Preoperative anxiety: detection and 
contributing factors. Can J Anaesth 1990; 37: 444–7   
4. Macario A, Weinger M, Carney S, Kim A. Which clinical anesthesia outcomes are important to 
avoid? The perspective of patients. Anesth Analg 1999; 89: 652 – 8   
5. Oldman M, Moore D, Collins S. Drug patient information leaflets in anaesthesia: effect on anxiety 
and patient satisfaction. Br J Anaesth 2004; 92: 854–8   
6. Norris W, Baird WL. Pre-operative anxiety: a study of the incidence and aetiology. Br J Anaesth 
1967; 39: 503–9   
7.  Doering S, Katzlberger F, Rumpold G, et al. Videotape preparation of patients before hip 
replacement surgery reduces stress. Psychosom Med 2000; 62: 365 – 73 
8. Williams JG, Jones JR. Psychophysiological responses to anesthesia and operation. J Am Med 
Assoc 1968; 203: 415 – 7  
9.  McCleane GJ, Cooper R. The nature of pre-operative anxiety. Anaesthesia 1990; 45: 153–5   
10.  Goldmann L, Ogg TW, Levey AB. Hypnosis and daycase anaesthesia. A study to reduce pre-
operative anxiety and intra-operative anaesthetic requirements. Anaesthesia 1988; 43: 466–9 
11.  Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic 
consumption: a qualitative systematic review. Anesthesiology 2009; 111: 657–77   
12.  Thomas T, Robinson C, Champion D, McKell M, Pell M. Prediction and assessment of the 
severity of post-operative pain and of satisfaction with management. Pain 1998;75: 177–85   
13.  Lee A, Chui PT, Gin T. Educating patients about anesthesia: a systematic review of randomized 
controlled trials of media-based interventions. Anesth Analg 2003;96:1424–31  
14. Caumo, W, Schmidt, AP, Bergamann J, Ivamoto, CW, Adamatti, LC, Ferreira, MB. Risk factors for 
preoperative anxiety in adults. Acta Anaesthesiology Scandinavica, 2001;45(3); 298-307 

Sinossi del protocollo di studio 
Study CERU-1801, Version 1.1 of 03.11.2015 
pagina 5/5 
15. Grossi, G., Perski, A., Feleke, E., Jacobson, U. State anxiety predicts poor psychosocial outcome 
after coronary bypass surgery. International Journal Behavioral Medicine, 1998;5:1–16 
16. Jones MP, Ebert CC, Sloan T, Spanier J, Bansal A, Howden CW, Vanagunas, AD. Patient anxiety 
and elective gastrointestinal endoscopy. Journal of Clinic  Gastroenterology, 2004;38(1):35-40 
17. Takahashi Y, Tanaka H, Kinjo M, Sakumoto K. Prospective evaluation of factors predicting 
difficulty and pain during sedation-free colonoscopy. Disease of the Colon & Rectum, 
2005;48(6):1295-1300 
18. Pager CK. Randomised controlled trial of preoperative information to improve satisfaction with 
cataract surgery. British Journal of Ophtalmology, 2005;89(1):10-3 
19. Freed LH, Ellen JM, Irwin CE, Millinstein SG. Determinants of adolescents’ satisfaction with health 
care providers and intentions to keep follow-up appointments. J Adolesc Health 1998;22(6):475-9 
20. Rohaiyem ME, Alshehri AA, Saade M, Shoabi TA, Zaboor H, Tawfeeg NA. Fear of going under 
general anesthesia: a cross-sectional study. Saudi J Anaesth 2016;10(3):317-21 
21. Ramsay, M. A survey of pre-operative fear. Anaesthesia, 1972;27(4); 396-402. 
22. Baker WH. Medical meeting: the real value. Bull Am Coll Surg 2001;86(11):13-8 
23. Sigdel S. Perioperative anxiety: a short review. Glob Anesth Perioper Med, 2015;1(4):107-8 
24. Kiyohara LY, Kavano LK, Oliveira LM, Yamamoto MU, Inagaki MM, Ogawa NY, Gonzales PE, 
Mandelbaum R, Okubo ST, Watanuki T, Vieira JE. Surgery information reduces anxiety in the pre-
operative period. Rev Hosp Clin Fac Med Sao Paulo 2004;59(2):51-6 
25.  Bondy LR, Sims N, Schroeder DR, Offord KP, Narr BJ. The effect of anesthetic patient education 
on preoperative patient anxiety. Reg Anesth Pain Med 1999; 24: 158–64   
26.  Hughes S. The effects of giving patients pre-operative information. Nurs Stand 2002; 16: 33–7