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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training video arm | Experimental | Patients will watch a personalized custom training video, in addition to the standard explanation provided by the medical staff |
|
| Verbal explanation arm | No Intervention | Patients will standard explanation about the procedure, provided by the medical staff |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized training video | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Orit Neudorfer, MD | Contact | +972-54-8886421 | orit.neudorfer@gmail.com | |
| Ori Rogovsky, MD | Contact | +972-52-4266770 | orirog@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Orit Neudorfer, MD | GistMed Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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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 |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |