Clinical trial NCT03581097: Educational Video and Peri-operative Anxiety
Official title: The Effect of Informational Videos on Preoperative Anxiety and Satisfaction Levels in Patients Undergoing Elective Ambulatory Surgery. A Case-control Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ambulatory Surgical Procedures
Anxiety Disorders
Keywords: Anxiety disorders
hand surgery
Educational Video
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Retrospective, single centre, case-control trial
Primary purpose: TREATMENT

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.

Detailed description: Anxiety is a common problem in patients undergoing invasive procedures, arriving in some studies up to 60-80%. Perioperative anxiety is correlated with hemodynamic effects (such as arterial hypertension and arrhythmias), it can have an impact on final surgical outcome, on anaesthetics drug dosage, and also with an growth about the perception of post-operative pain, leading to a substantial increase in analgesics dose and the number of post-operative hospitalization days. Finally, perioperative anxiety can reduce the patient's overall satisfaction with the quality of perioperative care.

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)
timeFrame: 2 hours
Secondary outcomes:
measure: Degree of Satisfaction
timeFrame: 3 hours
measure: Vital Parameters 1: Arterial Blood Pressure
timeFrame: 2 hours
measure: Vital Parameters 2: Respiratory Rate
timeFrame: 2 hours
measure: Vital Parameters 3: Heart Rate
timeFrame: 2 hours
measure: First Subgroups Analyze: Anxious Patients
timeFrame: 2 hours
measure: Second Subgroups Analyze: Higher Anxiety Score
timeFrame: 2 hours
measure: Third Subgroup Analyze: First Experience With Surgery.
timeFrame: 2 hours
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Andrea Saporito MD
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Cesare Fusetti, MD
role: PRINCIPAL_INVESTIGATOR
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