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Educational Video and Peri-operative Anxiety

Sponsor
University Hospital, Geneva (Other)
Overall Status
Completed
CT.gov ID
NCT03581097
Collaborator
(none)
93
Enrollment
1
Location
2
Arms
64.2
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Video Group
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Retrospective, single centre, case-control trialRetrospective, single centre, case-control trial
Masking:
Single (Investigator)
Masking Description:
Surgeon and investigators involved in subsequent data analysis were blinded to group assignment
Primary Purpose:
Treatment
Official Title:
The Effect of Informational Videos on Preoperative Anxiety and Satisfaction Levels in Patients Undergoing Elective Ambulatory Surgery. A Case-control Clinical Trial
Actual Study Start Date :
Feb 1, 2013
Actual Primary Completion Date :
May 30, 2013
Actual Study Completion Date :
Jun 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Video Group

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 intravenous regional anesthesia

Other: Video Group
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)
No Intervention: Control Group

Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. First Subgroups Analyze: Anxious Patients [2 hours]

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

  6. 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).

  7. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Andrea Saporito MD Bellinzona Switzerland 6500

Sponsors and Collaborators

  • University Hospital, Geneva

Investigators

  • Principal Investigator: Cesare Fusetti, MD, Ente Ospedaliero Cantonale, Bellinzona

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Samuele Ceruti, Dr. med., University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT03581097
Other Study ID Numbers:
  • CERU-1801
First Posted:
Jul 10, 2018
Last Update Posted:
Sep 13, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Samuele Ceruti, Dr. med., University Hospital, Geneva
Anxiety disorders
hand surgery
Educational Video
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

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 Detail Patients were randomized with a free web tool (available at www.randomizer.org) in a consecutive order into two parallels groups
Arm/Group Title Video Group Control Group
Arm/Group Description 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 Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
Period Title: Overall Study
STARTED 46 47
COMPLETED 46 47
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Video Group Control Group Total
Arm/Group Description 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 Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure. Total of all reporting groups
Overall Participants 46 47 93
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
56.5
(14.8)
54.8
(14.4)
55.65
(14.6)
Sex: Female, Male (Count of Participants)
Female
27
58.7%
23
48.9%
50
53.8%
Male
19
41.3%
24
51.1%
43
46.2%
Right-hand dominance (Count of Participants)
Count of Participants [Participants]
42
91.3%
43
91.5%
85
91.4%
Systolic arterial pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]
139.4
(22.1)
129.2
(17.8)
134.3
(19.95)
Diastolic arterial pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]
81.7
(10.9)
78.4
(10.1)
80.05
(10.5)
Heart Rate (bpm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [bpm]
75.4
(13.1)
71.8
(10.2)
73.6
(11.65)
Breath rate (Breath per minute) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Breath per minute]
14.7
(3.1)
13.8
(1.5)
14.25
(2.3)
Basal anxiety level (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
1.2
(1.1)
1.0
(1.2)
1.1
(1.15)

Outcome Measures

1. Primary Outcome
Title VAS-A Score Anxiety Level (Adapted Visual-Analogue Scale)
Description 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

Outcome Measure Data

Analysis Population Description
Anxiety level measured on admission in the day-hospital clinic
Arm/Group Title Video Group Control Group
Arm/Group Description 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) Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
Measure Participants 46 47
Mean (Standard Deviation) [score on a scale]
1.22
(1.12)
1.02
(1.24)
2. Secondary Outcome
Title Degree of Satisfaction
Description 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

Outcome Measure Data

Analysis Population Description
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/Group Title Video Group Control Group
Arm/Group Description 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 Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
Measure Participants 46 47
General environment
9.38
(1.01)
9.5
(0.83)
Equipments
9.5
(0.83)
9.5
(1.02)
Organization of departments
9.61
(0.75)
9.51
(0.83)
Waiting list
8.56
(2.15)
8.84
(1.81)
Pharmacy Service
9.42
(1.13)
9.55
(1.09)
Nursing professionals
9.68
(0.6)
9.68
(1.04)
Medical professionalism
9.9
(0.29)
9.73
(1.06)
Informations
9.86
(0.34)
9.72
(0.79)
Time dedicated to patient
9.76
(0.47)
9.5
(1.13)
3. Secondary Outcome
Title Vital Parameters 1: Arterial Blood Pressure
Description 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

Outcome Measure Data

Analysis Population Description
Systolic arterial pressure measured on admission in the day-hospital clinic.
Arm/Group Title Video Group Control Group
Arm/Group Description 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 Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
Measure Participants 46 47
Systolic Arterial Pressure
139.36
(22.08)
129.17
(17.8)
Diastolic Arterial Pressure
81.69
(10.9)
78.43
(10.12)
4. Secondary Outcome
Title Vital Parameters 2: Respiratory Rate
Description 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

Outcome Measure Data

Analysis Population Description
Respiratory rate at anesthesia
Arm/Group Title Video Group Control Group
Arm/Group Description 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 Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
Measure Participants 46 47
Mean (Standard Deviation) [breath per minute]
14.71
(3.07)
13.86
(1.48)
5. Secondary Outcome
Title Vital Parameters 3: Heart Rate
Description 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

Outcome Measure Data

Analysis Population Description
Cardiac rate at anesthesia
Arm/Group Title Video Group Control Group
Arm/Group Description 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 Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
Measure Participants 46 47
Mean (Standard Deviation) [bpm]
75.45
(13.08)
71.76
(10.23)
6. Secondary Outcome
Title First Subgroups Analyze: Anxious Patients
Description A subgroup analysis was performed applied to specific subgroups, like anxious patients.
Time Frame 2 hours

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Video Group Control Group
Arm/Group Description 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 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) Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
Measure Participants 15 13
Systolic arterial Pressure
135
(33.04)
138
(21.2)
Diastolic Arterial Pressure
83
(5.6)
79
(11.13)
7. Secondary Outcome
Title Second Subgroups Analyze: Higher Anxiety Score
Description 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

Outcome Measure Data

Analysis Population Description
This analysis is made to see if video is ineffective in reducing anxiety level
Arm/Group Title Video Group Control Group
Arm/Group Description 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 Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
Measure Participants 16 10
Systolic Arterial Pressure
129.36
(34.73)
127.11
(10.74)
Diastolic Arterial Pressure
78.21
(13.9)
72.7
(7.54)
8. Secondary Outcome
Title Third Subgroup Analyze: First Experience With Surgery.
Description 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

Outcome Measure Data

Analysis Population Description
A third subgroup analysis took into account patients for whom the operation was their first surgical experience.
Arm/Group Title Video Group Control Group
Arm/Group Description 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 Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
Measure Participants 23 19
Systolic Arterial Pressure
132.65
(32.56)
129.82
(15.28)
Diastolic Arterial Pressure
80.8
(9.77)
74.7
(11.1)

Adverse Events

Time Frame 2 hours after surgical intervention
Adverse Event Reporting Description The authors did not foresee the appearance of side effects after viewing the video.
Arm/Group Title Video Group Control Group
Arm/Group Description 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 Patients assigned to this control group were not shown the video and underwent an otherwise identical preoperative preparation procedure.
All Cause Mortality
Video Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/46 (0%) 0/47 (0%)
Serious Adverse Events
Video Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/46 (0%) 0/47 (0%)
Other (Not Including Serious) Adverse Events
Video Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/46 (0%) 0/47 (0%)

Limitations/Caveats

Authors adopted the VAS score. Type of surgery has been shown to influence anxiety levels. The study was not adequately powered to assess statistical significance of these secondary outcomes.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Dr. med. Andrea Saporito, Vice-Chair Department of Anesthesia
Organization Ospedale Regionale di Bellinzona e Valli (ORBV)
Phone 091/811.91.11
Email andrea.saporito@eoc.ch
Responsible Party:
Samuele Ceruti, Dr. med., University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT03581097
Other Study ID Numbers:
  • CERU-1801
First Posted:
Jul 10, 2018
Last Update Posted:
Sep 13, 2019
Last Verified:
Aug 1, 2019