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NCT03581097

Educational Video and Peri-operative Anxiety

Completed NA Results posted Last updated 13 September 2019
What this trial tests

NA trial testing Video Group in Ambulatory Surgical Procedures in 93 participants. Completed in 10 June 2018.

Timeline
1 February 2013
Primary endpoint
30 May 2013
10 June 2018

Quick facts

Lead sponsorUniversity Hospital, Geneva
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment93
Start date1 February 2013
Primary completion30 May 2013
Estimated completion10 June 2018
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Geneva

Who can join

18 and older, any sex, with Ambulatory Surgical Procedures or Anxiety Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale) Primary · 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.

GroupValue95% CI
Video Group1.22± 1.12
Control Group1.02± 1.24
Degree of Satisfaction Secondary · 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.

General environment
GroupValue95% CI
Video Group9.38± 1.01
Control Group9.5± 0.83
Equipments
GroupValue95% CI
Video Group9.5± 0.83
Control Group9.5± 1.02
Organization of departments
GroupValue95% CI
Video Group9.61± 0.75
Control Group9.51± 0.83
Waiting list
GroupValue95% CI
Video Group8.56± 2.15
Control Group8.84± 1.81
Pharmacy Service
GroupValue95% CI
Video Group9.42± 1.13
Control Group9.55± 1.09
Nursing professionals
GroupValue95% CI
Video Group9.68± 0.6
Control Group9.68± 1.04
Medical professionalism
GroupValue95% CI
Video Group9.9± 0.29
Control Group9.73± 1.06
Informations
GroupValue95% CI
Video Group9.86± 0.34
Control Group9.72± 0.79
Vital Parameters 1: Arterial Blood Pressure Secondary · 2 hours

To see any variance in vital parameters that are usually affected by anxiety, like arterial blood pressure \[mmHg\] in all patients.

Systolic Arterial Pressure
GroupValue95% CI
Video Group139.36± 22.08
Control Group129.17± 17.8
Diastolic Arterial Pressure
GroupValue95% CI
Video Group81.69± 10.9
Control Group78.43± 10.12
Vital Parameters 2: Respiratory Rate Secondary · 2 hours

To see any variance in vital parameters that are usually affected by anxiety like respiratory rate \[breath per minute\] in all patients.

GroupValue95% CI
Video Group14.71± 3.07
Control Group13.86± 1.48
Vital Parameters 3: Heart Rate Secondary · 2 hours

To see any variance in vital parameters that are usually affected by anxiety like heart rate \[beat per minute\] in all patients.

GroupValue95% CI
Video Group75.45± 13.08
Control Group71.76± 10.23
First Subgroups Analyze: Anxious Patients Secondary · 2 hours

A subgroup analysis was performed applied to specific subgroups, like anxious patients.

Systolic arterial Pressure
GroupValue95% CI
Video Group135± 33.04
Control Group138± 21.2
Diastolic Arterial Pressure
GroupValue95% CI
Video Group83± 5.6
Control Group79± 11.13
Second Subgroups Analyze: Higher Anxiety Score Secondary · 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
GroupValue95% CI
Video Group129.36± 34.73
Control Group127.11± 10.74
Diastolic Arterial Pressure
GroupValue95% CI
Video Group78.21± 13.9
Control Group72.7± 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
GroupValue95% CI
Video Group132.65± 32.56
Control Group129.82± 15.28
Diastolic Arterial Pressure
GroupValue95% CI
Video Group80.8± 9.77
Control Group74.7± 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.

Verify or expand the search:

Other trials of Video Group

Trials testing the same drug.

Other recruiting trials for Ambulatory Surgical Procedures

Currently open trials in the same condition.

Other University Hospital, Geneva trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing