AnxietyNCT02009553
Pre-procedural Information Sheet Reduces Anxiety of Patients Before Urodynamic Studies
An observational study of Anxiety, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is that pre-procedural explanation note about the test may reduce the anxiety level of the patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Information sheet and No information sheet
- How many people
- 104 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Dec 2014
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will be designated to have multichannel Uridynamic study in our center.
Who may be able to join
- All patients who will be referred for Urodynamic studies in order to evaluate lower urinary tract symptoms.
Who cannot join
- inability to complete the questionnaire due to mental disorders
- patients who had undergone Urodynamic study previously
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assaf Harofe Medical Center
Beer Yaakov, Zeriffin, 70300
Kobi Stav, MD, 972-8-9778461, stavkobi@gmail.com
Kobi Stav, MD
About this study
Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is that pre-procedural explanation note about the test may reduce the anxiety level of the patients.
Read the detailed description
Urodynamic study is one of the most common procedures in urological outpatient practice. Patients who wait for the tests may experience significant anxiety.
in this study, patients who are designated to have multichannel Urodynamic study will be randomized to two groups: group 1 - patients who received an explanation note about the test; group 2 - patients who did not receive the note. The explanation notes will be sent to the patients in group 1 by mail one month before the test.
Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress immediately before the test. Comparison opf the anxiety level between the two groups will be performed.
- Conditions
- Anxiety
- Being tested
- Information sheet, No information sheet
- Keywords
- Anxiety, Urodynamics
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information sheetOther
No information sheetOther
| Study group | Role | What they receive |
|---|---|---|
| Information sheet, Applied | In this group, all patients will receive the information sheet one month before the procedure Receives: Other: Information sheet | |
| Information sheet, not applied | In this group, patients will not receive a pre-procedural information sheet Receives: Other: No information sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Inventory
Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress. The SAI is a validated questionnaire composed of 20-items measures of anxiety (e.g. ''I am anxious''). Respondents will be requested to rate their endorsement of each item on a four-point scale.
Measured: 10 minutes before the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kobi Stav, MD, Principal investigator, Assaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009553
- Sponsor's protocol ID
- 167/13
- Other IDs
- 167/13
- Status last verified
- Dec 2013
- First submitted
- 2 Dec 2013
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-procedural Information Sheet Reduces Anxiety of Patients Before Urodynamic Studies
- ClinicalTrials.gov ID
- NCT02009553
- Acronym / sponsor ID
- 167/13
- Conditions
- Anxiety
- Keywords
- Anxiety, Urodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 12 Dec 2013 (estimated)
- 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.
Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is that pre-procedural explanation note about the test may reduce the anxiety level of the patients.
Detailed description
Urodynamic study is one of the most common procedures in urological outpatient practice. Patients who wait for the tests may experience significant anxiety.
in this study, patients who are designated to have multichannel Urodynamic study will be randomized to two groups: group 1 - patients who received an explanation note about the test; group 2 - patients who did not receive the note. The explanation notes will be sent to the patients in group 1 by mail one month before the test.
Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress immediately before the test. Comparison opf the anxiety level between the two groups will be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information sheet, Applied | – | Other: Information sheetIn this group, all patients will receive the information sheet one month before the procedure |
| Information sheet, not applied | – | Other: No information sheetIn this group, patients will not receive a pre-procedural information sheet |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be designated to have multichannel Uridynamic study in our center.
Key inclusion criteria (1 listed)
- All patients who will be referred for Urodynamic studies in order to evaluate lower urinary tract symptoms.
Key exclusion criteria (2 listed)
- inability to complete the questionnaire due to mental disorders
- patients who had undergone Urodynamic study previously
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 |
|---|---|---|
| Information sheet | Other | Information sheet, Applied |
| No information sheet | Other | Information sheet, not applied |
Primary outcome
State Anxiety Inventory
Time frame: 10 minutes before the test
Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress. The SAI is a validated questionnaire composed of 20-items measures of anxiety (e.g. ''I am anxious''). Respondents will be requested to rate their endorsement of each item on a four-point scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
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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.
Kobi Stav, MD principal investigator
Assaf Harofe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Assaf-Harofeh Medical Center 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 1 inclusion and 2 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 12 Dec 2013. 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 Kobi Stav, MD (972-8-9778461, stavkobi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Inventory (time frame: 10 minutes before the test). 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 12 Dec 2013.