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.
Group
Value
95% CI
Video Group
1.22
± 1.12
Control Group
1.02
± 1.24
Degree of SatisfactionSecondary· 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.
To see any variance in vital parameters that are usually affected by anxiety like respiratory rate \[breath per minute\] in all patients.
Group
Value
95% CI
Video Group
14.71
± 3.07
Control Group
13.86
± 1.48
Vital Parameters 3: Heart RateSecondary· 2 hours
To see any variance in vital parameters that are usually affected by anxiety like heart rate \[beat per minute\] in all patients.
Group
Value
95% CI
Video Group
75.45
± 13.08
Control Group
71.76
± 10.23
First Subgroups Analyze: Anxious PatientsSecondary· 2 hours
A subgroup analysis was performed applied to specific subgroups, like anxious patients.
Systolic arterial Pressure
Group
Value
95% CI
Video Group
135
± 33.04
Control Group
138
± 21.2
Diastolic Arterial Pressure
Group
Value
95% CI
Video Group
83
± 5.6
Control Group
79
± 11.13
Second Subgroups Analyze: Higher Anxiety ScoreSecondary· 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).
Systolic Arterial Pressure
Group
Value
95% CI
Video Group
129.36
± 34.73
Control Group
127.11
± 10.74
Diastolic Arterial Pressure
Group
Value
95% CI
Video Group
78.21
± 13.9
Control Group
72.7
± 7.54
Third Subgroup Analyze: First Experience With Surgery.Secondary· 2 hours
A subgroup analysis was performed applied to specific subgroups, like patients at their first experience with surgery, identified by specific questionnaire.
Systolic Arterial Pressure
Group
Value
95% CI
Video Group
132.65
± 32.56
Control Group
129.82
± 15.28
Diastolic Arterial Pressure
Group
Value
95% CI
Video Group
80.8
± 9.77
Control Group
74.7
± 11.1
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University Hospital, Geneva
Last refreshed: 13 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03581097.