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

Not Applicable
Conditions
Pleural Pleurisy Effusion
Pleural Effusion, Malignant
Pleural Effusion
Interventions
Other: Personalized training video
Registration Number
NCT04254445
Lead Sponsor
GistMed Ltd.
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Training video armPersonalized training videoPatients will watch a personalized custom training video, in addition to the standard explanation provided by the medical staff
Primary Outcome Measures
NameTimeMethod
Fulfillment of need for information gap30 minutes

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 Anxiety30 minutes

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
NameTimeMethod
The need of an active role30 Minutes

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 actions30 minutes

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

Trial Locations

Locations (1)

Tel Aviv Sourasky Medical Center

🇮🇱

Tel Aviv, Israel

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