Use of Guidance Videos to Increase Engagement and Decrease Anxiety in Patients Undergoing Pleural Tap

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Personalized Custom Training Videos on Patient Engagement in Hospitalized Patients Undergoing Thoracocentesis

Conditions
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Pleural Effusion, Pleural Effusion, Malignant, Pleural Pleurisy Effusion

Intervention / Treatment
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* Other: Personalized training video


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training video arm<br>Patients will watch a personalized custom training video, in addition to the standard explanation provided by the medical staff | Other: Personalized training video<br>* 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.<br>|
| No Intervention: Verbal explanation arm<br>Patients will standard explanation about the procedure, provided by the medical staff | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 minutes | 
| 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 | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 Minutes | 
| 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 | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Personalized video training, Thoracocentesis, Pleural tap