Ambulatory Surgical Procedures, Anxiety Disorders
Conditions
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital Parameters 1: Arterial Blood Pressure | 2 hours | 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 | 2 hours | 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 | 2 hours | To see any variance in vital parameters that are usually affected by anxiety like heart rate \[beat per minute\] in all patients. |
| Degree of Satisfaction | 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. |
| Second Subgroups Analyze: Higher Anxiety Score | 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). |
| Third Subgroup Analyze: First Experience With Surgery. | 2 hours | A subgroup analysis was performed applied to specific subgroups, like patients at their first experience with surgery, identified by specific questionnaire. |
| First Subgroups Analyze: Anxious Patients | 2 hours | A 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
| Arm | Count |
|---|---|
| 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 |
| Total | 93 |
Baseline characteristics
| Characteristic | Video Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 56.5 years STANDARD_DEVIATION 14.8 | 54.8 years STANDARD_DEVIATION 14.4 | 55.65 years STANDARD_DEVIATION 14.6 |
| Basal anxiety level | 1.2 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 rate | 14.7 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 pressure | 81.7 mmHg STANDARD_DEVIATION 10.9 | 78.4 mmHg STANDARD_DEVIATION 10.1 | 80.05 mmHg STANDARD_DEVIATION 10.5 |
| Heart Rate | 75.4 bpm STANDARD_DEVIATION 13.1 | 71.8 bpm STANDARD_DEVIATION 10.2 | 73.6 bpm STANDARD_DEVIATION 11.65 |
| Right-hand dominance | 42 Participants | 43 Participants | 85 Participants |
| Sex: Female, Male Female | 27 Participants | 23 Participants | 50 Participants |
| Sex: Female, Male Male | 19 Participants | 24 Participants | 43 Participants |
| Systolic arterial pressure | 139.4 mmHg STANDARD_DEVIATION 22.1 | 129.2 mmHg STANDARD_DEVIATION 17.8 | 134.3 mmHg STANDARD_DEVIATION 19.95 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 47 |
| other Total, other adverse events | 0 / 46 | 0 / 47 |
| serious Total, serious adverse events | 0 / 46 | 0 / 47 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video Group | VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale) | 1.22 score on a scale | Standard Deviation 1.12 |
| Control Group | VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale) | 1.02 score on a scale | Standard Deviation 1.24 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video Group | Degree of Satisfaction | Equipments | 9.5 units on a scale (0-10) | Standard Deviation 0.83 |
| Video Group | Degree of Satisfaction | Nursing professionals | 9.68 units on a scale (0-10) | Standard Deviation 0.6 |
| Video Group | Degree of Satisfaction | Waiting list | 8.56 units on a scale (0-10) | Standard Deviation 2.15 |
| Video Group | Degree of Satisfaction | Medical professionalism | 9.9 units on a scale (0-10) | Standard Deviation 0.29 |
| Video Group | Degree of Satisfaction | Organization of departments | 9.61 units on a scale (0-10) | Standard Deviation 0.75 |
| Video Group | Degree of Satisfaction | Informations | 9.86 units on a scale (0-10) | Standard Deviation 0.34 |
| Video Group | Degree of Satisfaction | Pharmacy Service | 9.42 units on a scale (0-10) | Standard Deviation 1.13 |
| Video Group | Degree of Satisfaction | Time dedicated to patient | 9.76 units on a scale (0-10) | Standard Deviation 0.47 |
| Video Group | Degree of Satisfaction | General environment | 9.38 units on a scale (0-10) | Standard Deviation 1.01 |
| Control Group | Degree of Satisfaction | Time dedicated to patient | 9.5 units on a scale (0-10) | Standard Deviation 1.13 |
| Control Group | Degree of Satisfaction | General environment | 9.5 units on a scale (0-10) | Standard Deviation 0.83 |
| Control Group | Degree of Satisfaction | Equipments | 9.5 units on a scale (0-10) | Standard Deviation 1.02 |
| Control Group | Degree of Satisfaction | Organization of departments | 9.51 units on a scale (0-10) | Standard Deviation 0.83 |
| Control Group | Degree of Satisfaction | Waiting list | 8.84 units on a scale (0-10) | Standard Deviation 1.81 |
| Control Group | Degree of Satisfaction | Pharmacy Service | 9.55 units on a scale (0-10) | Standard Deviation 1.09 |
| Control Group | Degree of Satisfaction | Nursing professionals | 9.68 units on a scale (0-10) | Standard Deviation 1.04 |
| Control Group | Degree of Satisfaction | Medical professionalism | 9.73 units on a scale (0-10) | Standard Deviation 1.06 |
| Control Group | Degree of Satisfaction | Informations | 9.72 units on a scale (0-10) | Standard Deviation 0.79 |
First Subgroups Analyze: Anxious Patients
A subgroup analysis was performed applied to specific subgroups, like anxious patients.
Time frame: 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video Group | First Subgroups Analyze: Anxious Patients | Systolic arterial Pressure | 135 mmHg | Standard Deviation 33.04 |
| Video Group | First Subgroups Analyze: Anxious Patients | Diastolic Arterial Pressure | 83 mmHg | Standard Deviation 5.6 |
| Control Group | First Subgroups Analyze: Anxious Patients | Diastolic Arterial Pressure | 79 mmHg | Standard Deviation 11.13 |
| Control Group | First Subgroups Analyze: Anxious Patients | Systolic arterial Pressure | 138 mmHg | Standard Deviation 21.2 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video Group | Second Subgroups Analyze: Higher Anxiety Score | Systolic Arterial Pressure | 129.36 mmHg | Standard Deviation 34.73 |
| Video Group | Second Subgroups Analyze: Higher Anxiety Score | Diastolic Arterial Pressure | 78.21 mmHg | Standard Deviation 13.9 |
| Control Group | Second Subgroups Analyze: Higher Anxiety Score | Systolic Arterial Pressure | 127.11 mmHg | Standard Deviation 10.74 |
| Control Group | Second Subgroups Analyze: Higher Anxiety Score | Diastolic Arterial Pressure | 72.7 mmHg | Standard Deviation 7.54 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video Group | Third Subgroup Analyze: First Experience With Surgery. | Systolic Arterial Pressure | 132.65 mmHg | Standard Deviation 32.56 |
| Video Group | Third Subgroup Analyze: First Experience With Surgery. | Diastolic Arterial Pressure | 80.8 mmHg | Standard Deviation 9.77 |
| Control Group | Third Subgroup Analyze: First Experience With Surgery. | Systolic Arterial Pressure | 129.82 mmHg | Standard Deviation 15.28 |
| Control Group | Third Subgroup Analyze: First Experience With Surgery. | Diastolic Arterial Pressure | 74.7 mmHg | Standard Deviation 11.1 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video Group | Vital Parameters 1: Arterial Blood Pressure | Systolic Arterial Pressure | 139.36 mmHg | Standard Deviation 22.08 |
| Video Group | Vital Parameters 1: Arterial Blood Pressure | Diastolic Arterial Pressure | 81.69 mmHg | Standard Deviation 10.9 |
| Control Group | Vital Parameters 1: Arterial Blood Pressure | Systolic Arterial Pressure | 129.17 mmHg | Standard Deviation 17.8 |
| Control Group | Vital Parameters 1: Arterial Blood Pressure | Diastolic Arterial Pressure | 78.43 mmHg | Standard Deviation 10.12 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video Group | Vital Parameters 2: Respiratory Rate | 14.71 breath per minute | Standard Deviation 3.07 |
| Control Group | Vital Parameters 2: Respiratory Rate | 13.86 breath per minute | Standard Deviation 1.48 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video Group | Vital Parameters 3: Heart Rate | 75.45 bpm | Standard Deviation 13.08 |
| Control Group | Vital Parameters 3: Heart Rate | 71.76 bpm | Standard Deviation 10.23 |