Trial Outcomes & Findings for Educational Video and Peri-operative Anxiety (NCT NCT03581097)
NCT ID: NCT03581097
Last Updated: 2019-09-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
2 hours
Results posted on
2019-09-13
Participant Flow
A consecutive cohort of adult patients scheduled for elective ambulatory hand surgery of less than one-hour duration with an intravenous regional anesthesia was recruited
Patients were randomized with a free web tool (available at www.randomizer.org) in a consecutive order into two parallels groups
Participant milestones
| Measure |
Video Group
Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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
Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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 OR and the performance of IVRA
|
Control Group
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
|
Overall Study
COMPLETED
|
46
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Educational Video and Peri-operative Anxiety
Baseline characteristics by cohort
| Measure |
Video Group
n=46 Participants
Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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
Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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 OR and the performance of IVRA
|
Control Group
n=47 Participants
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
55.65 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Right-hand dominance
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Systolic arterial pressure
|
139.4 mmHg
STANDARD_DEVIATION 22.1 • n=5 Participants
|
129.2 mmHg
STANDARD_DEVIATION 17.8 • n=7 Participants
|
134.3 mmHg
STANDARD_DEVIATION 19.95 • n=5 Participants
|
|
Diastolic arterial pressure
|
81.7 mmHg
STANDARD_DEVIATION 10.9 • n=5 Participants
|
78.4 mmHg
STANDARD_DEVIATION 10.1 • n=7 Participants
|
80.05 mmHg
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Heart Rate
|
75.4 bpm
STANDARD_DEVIATION 13.1 • n=5 Participants
|
71.8 bpm
STANDARD_DEVIATION 10.2 • n=7 Participants
|
73.6 bpm
STANDARD_DEVIATION 11.65 • n=5 Participants
|
|
Breath rate
|
14.7 Breath per minute
STANDARD_DEVIATION 3.1 • n=5 Participants
|
13.8 Breath per minute
STANDARD_DEVIATION 1.5 • n=7 Participants
|
14.25 Breath per minute
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Basal anxiety level
|
1.2 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
1.0 units on a scale
STANDARD_DEVIATION 1.2 • n=7 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 1.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Anxiety level measured on admission in the day-hospital clinic
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.
Outcome measures
| Measure |
Video Group
n=46 Participants
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) score 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
Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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 OR and the performance of Intra-Venous regional Anesthesia (IVRA)
|
Control Group
n=47 Participants
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
|
|---|---|---|
|
VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)
|
1.22 score on a scale
Standard Deviation 1.12
|
1.02 score on a scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: 3 hoursPopulation: Control group underwent a surgical pre-operative examination, during which they received detailed information about surgical procedure but not regarding anesthetic technique. Video group patients received the same preoperative preparation procedur, and also watched a video group patients showed a 6-minute educational information video about IVRA.
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.
Outcome measures
| Measure |
Video Group
n=46 Participants
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) score 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
Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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 OR and the performance of Intra-Venous regional Anesthesia (IVRA)
|
Control Group
n=47 Participants
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
|
|---|---|---|
|
Degree of Satisfaction
General environment
|
9.38 units on a scale (0-10)
Standard Deviation 1.01
|
9.5 units on a scale (0-10)
Standard Deviation 0.83
|
|
Degree of Satisfaction
Equipments
|
9.5 units on a scale (0-10)
Standard Deviation 0.83
|
9.5 units on a scale (0-10)
Standard Deviation 1.02
|
|
Degree of Satisfaction
Organization of departments
|
9.61 units on a scale (0-10)
Standard Deviation 0.75
|
9.51 units on a scale (0-10)
Standard Deviation 0.83
|
|
Degree of Satisfaction
Waiting list
|
8.56 units on a scale (0-10)
Standard Deviation 2.15
|
8.84 units on a scale (0-10)
Standard Deviation 1.81
|
|
Degree of Satisfaction
Pharmacy Service
|
9.42 units on a scale (0-10)
Standard Deviation 1.13
|
9.55 units on a scale (0-10)
Standard Deviation 1.09
|
|
Degree of Satisfaction
Nursing professionals
|
9.68 units on a scale (0-10)
Standard Deviation 0.6
|
9.68 units on a scale (0-10)
Standard Deviation 1.04
|
|
Degree of Satisfaction
Medical professionalism
|
9.9 units on a scale (0-10)
Standard Deviation 0.29
|
9.73 units on a scale (0-10)
Standard Deviation 1.06
|
|
Degree of Satisfaction
Informations
|
9.86 units on a scale (0-10)
Standard Deviation 0.34
|
9.72 units on a scale (0-10)
Standard Deviation 0.79
|
|
Degree of Satisfaction
Time dedicated to patient
|
9.76 units on a scale (0-10)
Standard Deviation 0.47
|
9.5 units on a scale (0-10)
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Systolic arterial pressure measured on admission in the day-hospital clinic.
To see any variance in vital parameters that are usually affected by anxiety, like arterial blood pressure \[mmHg\] in all patients.
Outcome measures
| Measure |
Video Group
n=46 Participants
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) score 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
Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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 OR and the performance of Intra-Venous regional Anesthesia (IVRA)
|
Control Group
n=47 Participants
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
|
|---|---|---|
|
Vital Parameters 1: Arterial Blood Pressure
Systolic Arterial Pressure
|
139.36 mmHg
Standard Deviation 22.08
|
129.17 mmHg
Standard Deviation 17.8
|
|
Vital Parameters 1: Arterial Blood Pressure
Diastolic Arterial Pressure
|
81.69 mmHg
Standard Deviation 10.9
|
78.43 mmHg
Standard Deviation 10.12
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Respiratory rate at anesthesia
To see any variance in vital parameters that are usually affected by anxiety like respiratory rate \[breath per minute\] in all patients.
Outcome measures
| Measure |
Video Group
n=46 Participants
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) score 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
Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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 OR and the performance of Intra-Venous regional Anesthesia (IVRA)
|
Control Group
n=47 Participants
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
|
|---|---|---|
|
Vital Parameters 2: Respiratory Rate
|
14.71 breath per minute
Standard Deviation 3.07
|
13.86 breath per minute
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Cardiac rate at anesthesia
To see any variance in vital parameters that are usually affected by anxiety like heart rate \[beat per minute\] in all patients.
Outcome measures
| Measure |
Video Group
n=46 Participants
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) score 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
Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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 OR and the performance of Intra-Venous regional Anesthesia (IVRA)
|
Control Group
n=47 Participants
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
|
|---|---|---|
|
Vital Parameters 3: Heart Rate
|
75.45 bpm
Standard Deviation 13.08
|
71.76 bpm
Standard Deviation 10.23
|
SECONDARY outcome
Timeframe: 2 hoursA subgroup analysis was performed applied to specific subgroups, like anxious patients.
Outcome measures
| Measure |
Video Group
n=15 Participants
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) score 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
Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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 OR and the performance of Intra-Venous regional Anesthesia (IVRA)
|
Control Group
n=13 Participants
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
|
|---|---|---|
|
First Subgroups Analyze: Anxious Patients
Systolic arterial Pressure
|
135 mmHg
Standard Deviation 33.04
|
138 mmHg
Standard Deviation 21.2
|
|
First Subgroups Analyze: Anxious Patients
Diastolic Arterial Pressure
|
83 mmHg
Standard Deviation 5.6
|
79 mmHg
Standard Deviation 11.13
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: This analysis is made to see if video is ineffective in reducing anxiety level
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).
Outcome measures
| Measure |
Video Group
n=16 Participants
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) score 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
Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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 OR and the performance of Intra-Venous regional Anesthesia (IVRA)
|
Control Group
n=10 Participants
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
|
|---|---|---|
|
Second Subgroups Analyze: Higher Anxiety Score
Systolic Arterial Pressure
|
129.36 mmHg
Standard Deviation 34.73
|
127.11 mmHg
Standard Deviation 10.74
|
|
Second Subgroups Analyze: Higher Anxiety Score
Diastolic Arterial Pressure
|
78.21 mmHg
Standard Deviation 13.9
|
72.7 mmHg
Standard Deviation 7.54
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: A third subgroup analysis took into account patients for whom the operation was their first surgical experience.
A subgroup analysis was performed applied to specific subgroups, like patients at their first experience with surgery, identified by specific questionnaire.
Outcome measures
| Measure |
Video Group
n=23 Participants
Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) score 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
Video Group: Patients in the film group watched the film using a laptop computer equipped with headphones, and VAS score 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 OR and the performance of Intra-Venous regional Anesthesia (IVRA)
|
Control Group
n=19 Participants
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
|
|---|---|---|
|
Third Subgroup Analyze: First Experience With Surgery.
Systolic Arterial Pressure
|
132.65 mmHg
Standard Deviation 32.56
|
129.82 mmHg
Standard Deviation 15.28
|
|
Third Subgroup Analyze: First Experience With Surgery.
Diastolic Arterial Pressure
|
80.8 mmHg
Standard Deviation 9.77
|
74.7 mmHg
Standard Deviation 11.1
|
Adverse Events
Video Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. med. Andrea Saporito, Vice-Chair Department of Anesthesia
Ospedale Regionale di Bellinzona e Valli (ORBV)
Phone: 091/811.91.11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place