Pleural EffusionNCT04254445
Use of Guidance Videos to Increase Engagement and Decrease Anxiety in Patients Undergoing Pleural Tap
A study testing Personalized training video in people with Pleural Effusion and Pleural Effusion, Malignant, run by GistMed Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pleural Effusion, Pleural Effusion, Malignant, Pleural Pleurisy Effusion
- What is being tested?
- Personalized training video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Feb 2020to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv
Mor Gur Arie, 0503317516
About this study
Official title: The Effect of Personalized Custom Training Videos on Patient Engagement in Hospitalized Patients Undergoing Thoracocentesis
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.
Read the 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.
- Being tested
- Personalized training video
- Keywords
- Personalized video training, Thoracocentesis, Pleural tap
- Medical subject headings
- Pleural Effusion, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized training videoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Training video arm | Experimental | Patients will watch a personalized custom training video, in addition to the standard explanation provided by the medical staff Receives: Other: Personalized training video |
| Verbal explanation arm | No intervention | Patients will standard explanation about the procedure, provided by the medical staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 minutes
Secondary outcomes (2)
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
Measured: 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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start16 Feb 2020
- Primary completion30 May 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GistMed Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orit Neudorfer, MD, Study director, GistMed Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254445
- Sponsor's protocol ID
- 0009-19-TLV
- Status last verified
- Feb 2020
- First submitted
- 5 Jan 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Personalized Custom Training Videos on Patient Engagement in Hospitalized Patients Undergoing Thoracocentesis
- ClinicalTrials.gov ID
- NCT04254445
- Acronym / sponsor ID
- 0009-19-TLV
- Keywords
- Personalized video training, Thoracocentesis, Pleural tap
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GistMed Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2020 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training video arm | Experimental | Other: Personalized training videoPatients 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized training videoUsing 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. | Other | Training video arm |
Primary outcome
Fulfillment of need for information gap
Time frame: 30 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 Anxiety
Time frame: 30 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
2 secondary outcomes
The need of an active role
Time frame: 30 Minutes
Confidence and Knowledge to take actions
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orit Neudorfer, MD study director
GistMed Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized training video in people with Pleural Effusion and Pleural Effusion, Malignant, run by GistMed Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orit Neudorfer, MD (+972-54-8886421, orit.neudorfer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fulfillment of need for information gap (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020; AzTrials last refreshed its copy on 26 Oct 2026.