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

NCT ID: NCT04254445

Last Updated: 2020-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-16

Study Completion Date

2020-06-30

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.

Conditions

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Pleural Effusion Pleural Effusion, Malignant Pleural Pleurisy Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Training video arm

Patients will watch a personalized custom training video, in addition to the standard explanation provided by the medical staff

Group Type EXPERIMENTAL

Personalized training video

Intervention Type 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.

Verbal explanation arm

Patients will standard explanation about the procedure, provided by the medical staff

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GistMed Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Orit Neudorfer, MD

Role: STUDY_DIRECTOR

GistMed Ltd.

Locations

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Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Orit Neudorfer, MD

Role: CONTACT

+972-54-8886421

Ori Rogovsky, MD

Role: CONTACT

+972-52-4266770

Facility Contacts

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Mor Gur Arie

Role: primary

0503317516

Other Identifiers

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0009-19-TLV

Identifier Type: -

Identifier Source: org_study_id

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