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

Pleural Effusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04254445
• Other study ID #: 0009-19-TLV
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2020
• Source: GistMed Ltd.
• Contact: Orit Neudorfer, MD
• Phone: +972-54-8886421
• Email: orit.neudorfer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pleural Effusion
• Pleural Effusion, Malignant
• Pleural Pleurisy Effusion
• Pleurisy

Intervention

Other:
• Personalized training video
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.

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
GistMed Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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