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Educational Video and Peri-operative Anxiety

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03581097
Enrollment
93
Registered
2018-07-10
Start date
2013-02-01
Completion date
2018-06-10
Last updated
2019-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Surgical Procedures, Anxiety Disorders

Keywords

Anxiety disorders, hand surgery, Educational Video

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.

Interventions

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)

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

Surgeon and investigators involved in subsequent data analysis were blinded to group assignment

Intervention model description

Retrospective, single centre, case-control trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)2 hoursPrimary 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

MeasureTime frameDescription
Vital Parameters 1: Arterial Blood Pressure2 hoursTo see any variance in vital parameters that are usually affected by anxiety, like arterial blood pressure \[mmHg\] in all patients.
Vital Parameters 2: Respiratory Rate2 hoursTo 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 Rate2 hoursTo see any variance in vital parameters that are usually affected by anxiety like heart rate \[beat per minute\] in all patients.
Degree of Satisfaction3 hoursTo 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.
Second Subgroups Analyze: Higher Anxiety Score2 hoursA 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.2 hoursA subgroup analysis was performed applied to specific subgroups, like patients at their first experience with surgery, identified by specific questionnaire.
First Subgroups Analyze: Anxious Patients2 hoursA subgroup analysis was performed applied to specific subgroups, like anxious patients.

Countries

Switzerland

Participant flow

Recruitment details

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

Pre-assignment details

Patients were randomized with a free web tool (available at www.randomizer.org) in a consecutive order into two parallels groups

Participants by arm

ArmCount
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
46
Control Group
Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
47
Total93

Baseline characteristics

CharacteristicVideo GroupControl GroupTotal
Age, Continuous56.5 years
STANDARD_DEVIATION 14.8
54.8 years
STANDARD_DEVIATION 14.4
55.65 years
STANDARD_DEVIATION 14.6
Basal anxiety level1.2 units on a scale
STANDARD_DEVIATION 1.1
1.0 units on a scale
STANDARD_DEVIATION 1.2
1.1 units on a scale
STANDARD_DEVIATION 1.15
Breath rate14.7 Breath per minute
STANDARD_DEVIATION 3.1
13.8 Breath per minute
STANDARD_DEVIATION 1.5
14.25 Breath per minute
STANDARD_DEVIATION 2.3
Diastolic arterial pressure81.7 mmHg
STANDARD_DEVIATION 10.9
78.4 mmHg
STANDARD_DEVIATION 10.1
80.05 mmHg
STANDARD_DEVIATION 10.5
Heart Rate75.4 bpm
STANDARD_DEVIATION 13.1
71.8 bpm
STANDARD_DEVIATION 10.2
73.6 bpm
STANDARD_DEVIATION 11.65
Right-hand dominance42 Participants43 Participants85 Participants
Sex: Female, Male
Female
27 Participants23 Participants50 Participants
Sex: Female, Male
Male
19 Participants24 Participants43 Participants
Systolic arterial pressure139.4 mmHg
STANDARD_DEVIATION 22.1
129.2 mmHg
STANDARD_DEVIATION 17.8
134.3 mmHg
STANDARD_DEVIATION 19.95

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 460 / 47
other
Total, other adverse events
0 / 460 / 47
serious
Total, serious adverse events
0 / 460 / 47

Outcome results

Primary

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.

Time frame: 2 hours

Population: Anxiety level measured on admission in the day-hospital clinic

ArmMeasureValue (MEAN)Dispersion
Video GroupVAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)1.22 score on a scaleStandard Deviation 1.12
Control GroupVAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)1.02 score on a scaleStandard Deviation 1.24
Secondary

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.

Time frame: 3 hours

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Video GroupDegree of SatisfactionEquipments9.5 units on a scale (0-10)Standard Deviation 0.83
Video GroupDegree of SatisfactionNursing professionals9.68 units on a scale (0-10)Standard Deviation 0.6
Video GroupDegree of SatisfactionWaiting list8.56 units on a scale (0-10)Standard Deviation 2.15
Video GroupDegree of SatisfactionMedical professionalism9.9 units on a scale (0-10)Standard Deviation 0.29
Video GroupDegree of SatisfactionOrganization of departments9.61 units on a scale (0-10)Standard Deviation 0.75
Video GroupDegree of SatisfactionInformations9.86 units on a scale (0-10)Standard Deviation 0.34
Video GroupDegree of SatisfactionPharmacy Service9.42 units on a scale (0-10)Standard Deviation 1.13
Video GroupDegree of SatisfactionTime dedicated to patient9.76 units on a scale (0-10)Standard Deviation 0.47
Video GroupDegree of SatisfactionGeneral environment9.38 units on a scale (0-10)Standard Deviation 1.01
Control GroupDegree of SatisfactionTime dedicated to patient9.5 units on a scale (0-10)Standard Deviation 1.13
Control GroupDegree of SatisfactionGeneral environment9.5 units on a scale (0-10)Standard Deviation 0.83
Control GroupDegree of SatisfactionEquipments9.5 units on a scale (0-10)Standard Deviation 1.02
Control GroupDegree of SatisfactionOrganization of departments9.51 units on a scale (0-10)Standard Deviation 0.83
Control GroupDegree of SatisfactionWaiting list8.84 units on a scale (0-10)Standard Deviation 1.81
Control GroupDegree of SatisfactionPharmacy Service9.55 units on a scale (0-10)Standard Deviation 1.09
Control GroupDegree of SatisfactionNursing professionals9.68 units on a scale (0-10)Standard Deviation 1.04
Control GroupDegree of SatisfactionMedical professionalism9.73 units on a scale (0-10)Standard Deviation 1.06
Control GroupDegree of SatisfactionInformations9.72 units on a scale (0-10)Standard Deviation 0.79
Secondary

First Subgroups Analyze: Anxious Patients

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

Time frame: 2 hours

ArmMeasureGroupValue (MEAN)Dispersion
Video GroupFirst Subgroups Analyze: Anxious PatientsSystolic arterial Pressure135 mmHgStandard Deviation 33.04
Video GroupFirst Subgroups Analyze: Anxious PatientsDiastolic Arterial Pressure83 mmHgStandard Deviation 5.6
Control GroupFirst Subgroups Analyze: Anxious PatientsDiastolic Arterial Pressure79 mmHgStandard Deviation 11.13
Control GroupFirst Subgroups Analyze: Anxious PatientsSystolic arterial Pressure138 mmHgStandard Deviation 21.2
Secondary

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).

Time frame: 2 hours

Population: This analysis is made to see if video is ineffective in reducing anxiety level

ArmMeasureGroupValue (MEAN)Dispersion
Video GroupSecond Subgroups Analyze: Higher Anxiety ScoreSystolic Arterial Pressure129.36 mmHgStandard Deviation 34.73
Video GroupSecond Subgroups Analyze: Higher Anxiety ScoreDiastolic Arterial Pressure78.21 mmHgStandard Deviation 13.9
Control GroupSecond Subgroups Analyze: Higher Anxiety ScoreSystolic Arterial Pressure127.11 mmHgStandard Deviation 10.74
Control GroupSecond Subgroups Analyze: Higher Anxiety ScoreDiastolic Arterial Pressure72.7 mmHgStandard Deviation 7.54
Secondary

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.

Time frame: 2 hours

Population: A third subgroup analysis took into account patients for whom the operation was their first surgical experience.

ArmMeasureGroupValue (MEAN)Dispersion
Video GroupThird Subgroup Analyze: First Experience With Surgery.Systolic Arterial Pressure132.65 mmHgStandard Deviation 32.56
Video GroupThird Subgroup Analyze: First Experience With Surgery.Diastolic Arterial Pressure80.8 mmHgStandard Deviation 9.77
Control GroupThird Subgroup Analyze: First Experience With Surgery.Systolic Arterial Pressure129.82 mmHgStandard Deviation 15.28
Control GroupThird Subgroup Analyze: First Experience With Surgery.Diastolic Arterial Pressure74.7 mmHgStandard Deviation 11.1
Secondary

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.

Time frame: 2 hours

Population: Systolic arterial pressure measured on admission in the day-hospital clinic.

ArmMeasureGroupValue (MEAN)Dispersion
Video GroupVital Parameters 1: Arterial Blood PressureSystolic Arterial Pressure139.36 mmHgStandard Deviation 22.08
Video GroupVital Parameters 1: Arterial Blood PressureDiastolic Arterial Pressure81.69 mmHgStandard Deviation 10.9
Control GroupVital Parameters 1: Arterial Blood PressureSystolic Arterial Pressure129.17 mmHgStandard Deviation 17.8
Control GroupVital Parameters 1: Arterial Blood PressureDiastolic Arterial Pressure78.43 mmHgStandard Deviation 10.12
Secondary

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.

Time frame: 2 hours

Population: Respiratory rate at anesthesia

ArmMeasureValue (MEAN)Dispersion
Video GroupVital Parameters 2: Respiratory Rate14.71 breath per minuteStandard Deviation 3.07
Control GroupVital Parameters 2: Respiratory Rate13.86 breath per minuteStandard Deviation 1.48
Secondary

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.

Time frame: 2 hours

Population: Cardiac rate at anesthesia

ArmMeasureValue (MEAN)Dispersion
Video GroupVital Parameters 3: Heart Rate75.45 bpmStandard Deviation 13.08
Control GroupVital Parameters 3: Heart Rate71.76 bpmStandard Deviation 10.23

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026