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Educational Video and Peri-operative Anxiety

Primary Purpose

Ambulatory Surgical Procedures, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Video Group
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ambulatory Surgical Procedures focused on measuring Anxiety disorders, hand surgery, Educational Video

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Andrea Saporito MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Video Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Degree of Satisfaction
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.
Vital Parameters 1: Arterial Blood Pressure
To see any variance in vital parameters that are usually affected by anxiety, like arterial blood pressure [mmHg] in all patients.
Vital Parameters 2: Respiratory Rate
To see any variance in vital parameters that are usually affected by anxiety like respiratory rate [breath per minute] in all patients.
Vital Parameters 3: Heart Rate
To see any variance in vital parameters that are usually affected by anxiety like heart rate [beat per minute] in all patients.
First Subgroups Analyze: Anxious Patients
A subgroup analysis was performed applied to specific subgroups, like anxious patients.
Second Subgroups Analyze: Higher Anxiety Score
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).
Third Subgroup Analyze: First Experience With Surgery.
A subgroup analysis was performed applied to specific subgroups, like patients at their first experience with surgery, identified by specific questionnaire.

Full Information

First Posted
June 13, 2018
Last Updated
August 9, 2019
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT03581097
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
May 30, 2013 (Actual)
Study Completion Date
June 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ambulatory Surgical Procedures, Anxiety Disorders
Keywords
Anxiety disorders, hand surgery, Educational Video

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Retrospective, single centre, case-control trial
Masking
Investigator
Masking Description
Surgeon and investigators involved in subsequent data analysis were blinded to group assignment
Allocation
Non-Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
Intervention Type
Other
Intervention Name(s)
Video Group
Intervention Description
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)
Primary Outcome Measure Information:
Title
VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Degree of Satisfaction
Description
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.
Time Frame
3 hours
Title
Vital Parameters 1: Arterial Blood Pressure
Description
To see any variance in vital parameters that are usually affected by anxiety, like arterial blood pressure [mmHg] in all patients.
Time Frame
2 hours
Title
Vital Parameters 2: Respiratory Rate
Description
To see any variance in vital parameters that are usually affected by anxiety like respiratory rate [breath per minute] in all patients.
Time Frame
2 hours
Title
Vital Parameters 3: Heart Rate
Description
To see any variance in vital parameters that are usually affected by anxiety like heart rate [beat per minute] in all patients.
Time Frame
2 hours
Title
First Subgroups Analyze: Anxious Patients
Description
A subgroup analysis was performed applied to specific subgroups, like anxious patients.
Time Frame
2 hours
Title
Second Subgroups Analyze: Higher Anxiety Score
Description
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).
Time Frame
2 hours
Title
Third Subgroup Analyze: First Experience With Surgery.
Description
A subgroup analysis was performed applied to specific subgroups, like patients at their first experience with surgery, identified by specific questionnaire.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Fusetti, MD
Organizational Affiliation
Ente Ospedaliero Cantonale, Bellinzona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andrea Saporito MD
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Educational Video and Peri-operative Anxiety

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