Back to resultsUse of Guidance Videos to Increase Engagement and Decrease Anxiety in Patients Undergoing Pleural Tap
Primary Purpose
Pleural Effusion, Pleural Effusion, Malignant, Pleural Pleurisy Effusion
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Personalized training video
Sponsored by
About this trial
This is an interventional supportive care trial for Pleural Effusion focused on measuring Personalized video training, Thoracocentesis, Pleural tap
Eligibility Criteria
Inclusion Criteria:
- patients hospitalized in Internal medicine C and D, Tel-Aviv Sourasky Medical Centers
- Patients with pleural effusion, planned to undergo diagnostic or therapeutic pleural tap
- Patients who can read and understand the questions
- Patients who were interested in participating in the clinical trial and signed an informed consent form
Exclusion Criteria:
- Minors < 18 years of age
- Pregnant women
- Patients who cannot read and understand, at the discretion of the investigator
- Patients which their medical condition does not allow them to undergo the study procedure
Sites / Locations
- Tel Aviv Sourasky Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Training video arm
Verbal explanation arm
Arm Description
Patients will watch a personalized custom training video, in addition to the standard explanation provided by the medical staff
Patients will standard explanation about the procedure, provided by the medical staff
Outcomes
Primary Outcome Measures
Fulfillment of need for information gap
Improvement of subjective self-assessment of the patient's need of information on the tap procedure following the explanation received, based on the short form of the Quality from Patient Perspective (QPP) measurement. The improvement in the intervention arm will be compared to the one of the control arm
Assessment of Anxiety
Delta of subjective self-assessment on his/her anxiety about the procedure, following the explanation received (using visual scale of 1-100, based on the Visual Analog Scale (VAS)). The reduction of anxiety in the intervention arm will be compared to the one of the control arm
Secondary Outcome Measures
The need of an active role
The patients will be asked to score whether the explanation allowed them the active role they needed, based on the Picker Patient Experience (PPE-15) Questionnaire. The score in the intervention arm will be compared to the one of the control arm
Confidence and Knowledge to take actions
The patient would be asked to score whether the information they received allowed them to understand what they should do next, based on the Patient Activation Measure (PAM) Questionnaire. The score in the intervention arm will be compared to the one of the control arm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04254445
Brief Title
Use of Guidance Videos to Increase Engagement and Decrease Anxiety in Patients Undergoing Pleural Tap
Official Title
The Effect of Personalized Custom Training Videos on Patient Engagement in Hospitalized Patients Undergoing Thoracocentesis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 16, 2020 (Actual)
Primary Completion Date
May 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GistMed Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients planned to undergo a pleural tap will get verbal explanation or watch a personalized guidance video in addition to verbal explanation. Questionnaires will be filled to assess the effect of the video training on understanding, cooperation and anxiety.
Detailed Description
100 patients with pleural effusion, planned to undergo a diagnostic or therapeutic pleural tap, will be randomized to watch a personalized custom video training, explaining the procedure, in addition to the verbal explanation given by the medical staff, or to get the standard verbal explanation alone. Questionnaires regarding their understanding of the procedure, their feelings and the level of anxiety will be filled before and after the video/verbal explanation, and after the procedure. the study aims to check whether the video training provides better understanding of the procedure, increases cooperation and engagement and decreases anxiety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion, Pleural Effusion, Malignant, Pleural Pleurisy Effusion
Keywords
Personalized video training, Thoracocentesis, Pleural tap
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Training video arm
Arm Type
Experimental
Arm Description
Patients will watch a personalized custom training video, in addition to the standard explanation provided by the medical staff
Arm Title
Verbal explanation arm
Arm Type
No Intervention
Arm Description
Patients will standard explanation about the procedure, provided by the medical staff
Intervention Type
Other
Intervention Name(s)
Personalized training video
Intervention Description
Using a few demographic and medical details of the patients, provided by the medical staff, the video generator will create a 2-minute personalized custom video, suitable to the age, gender, language, and medical condition of the patients. No identifying information will be used, to protect patient's privacy.
Primary Outcome Measure Information:
Title
Fulfillment of need for information gap
Description
Improvement of subjective self-assessment of the patient's need of information on the tap procedure following the explanation received, based on the short form of the Quality from Patient Perspective (QPP) measurement. The improvement in the intervention arm will be compared to the one of the control arm
Time Frame
30 minutes
Title
Assessment of Anxiety
Description
Delta of subjective self-assessment on his/her anxiety about the procedure, following the explanation received (using visual scale of 1-100, based on the Visual Analog Scale (VAS)). The reduction of anxiety in the intervention arm will be compared to the one of the control arm
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
The need of an active role
Description
The patients will be asked to score whether the explanation allowed them the active role they needed, based on the Picker Patient Experience (PPE-15) Questionnaire. The score in the intervention arm will be compared to the one of the control arm
Time Frame
30 Minutes
Title
Confidence and Knowledge to take actions
Description
The patient would be asked to score whether the information they received allowed them to understand what they should do next, based on the Patient Activation Measure (PAM) Questionnaire. The score in the intervention arm will be compared to the one of the control arm
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients hospitalized in Internal medicine C and D, Tel-Aviv Sourasky Medical Centers
Patients with pleural effusion, planned to undergo diagnostic or therapeutic pleural tap
Patients who can read and understand the questions
Patients who were interested in participating in the clinical trial and signed an informed consent form
Exclusion Criteria:
Minors < 18 years of age
Pregnant women
Patients who cannot read and understand, at the discretion of the investigator
Patients which their medical condition does not allow them to undergo the study procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Orit Neudorfer, MD
Phone
+972-54-8886421
Email
orit.neudorfer@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ori Rogovsky, MD
Phone
+972-52-4266770
Email
orirog@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orit Neudorfer, MD
Organizational Affiliation
GistMed Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mor Gur Arie
Phone
0503317516
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Guidance Videos to Increase Engagement and Decrease Anxiety in Patients Undergoing Pleural Tap
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