Educational Video and Peri-operative Anxiety

August 9, 2019 updated by: Samuele Ceruti, University Hospital, Geneva

The Effect of Informational Videos on Preoperative Anxiety and Satisfaction Levels in Patients Undergoing Elective Ambulatory Surgery. A Case-control Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Andrea Saporito MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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)
No Intervention: Control Group
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)
Time Frame: 2 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of Satisfaction
Time Frame: 3 hours
To perceive any disparity in patient's satisfaction degree measured through final questionnaire. A satisfaction questionnaire with evaluation from 0 (min) to 10 (max) regarding this topics. Higher values represent the better outcome, lower values represent the worse outcome.
3 hours
Vital Parameters 1: Arterial Blood Pressure
Time Frame: 2 hours
To see any variance in vital parameters that are usually affected by anxiety, like arterial blood pressure [mmHg] in all patients.
2 hours
Vital Parameters 2: Respiratory Rate
Time Frame: 2 hours
To see any variance in vital parameters that are usually affected by anxiety like respiratory rate [breath per minute] in all patients.
2 hours
Vital Parameters 3: Heart Rate
Time Frame: 2 hours
To see any variance in vital parameters that are usually affected by anxiety like heart rate [beat per minute] in all patients.
2 hours
First Subgroups Analyze: Anxious Patients
Time Frame: 2 hours
A subgroup analysis was performed applied to specific subgroups, like anxious patients.
2 hours
Second Subgroups Analyze: Higher Anxiety Score
Time Frame: 2 hours
A subgroup analysis was performed applied to specific subgroups, like patients with higher anxiety assessment result, identified to have 3 or more on the 5 point on Visual Analog Scale - Adapted (VAS-A) score (ranging from 1 - no anxious - to 5 - totally anxious).
2 hours
Third Subgroup Analyze: First Experience With Surgery.
Time Frame: 2 hours
A subgroup analysis was performed applied to specific subgroups, like patients at their first experience with surgery, identified by specific questionnaire.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Principal Investigator: Cesare Fusetti, MD, Ente Ospedaliero Cantonale, Bellinzona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

May 30, 2013

Study Completion (Actual)

June 10, 2018

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

July 6, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERU-1801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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