Cardiac Valve DiseaseNCT06001489
The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
A study testing 360-degree Virtual Reality Patient Tour, State Trait Anxiety Inventory and Amsterdam Preoperative Anxiety and Information Scale in people with Cardiac Valve Disease and Aortic Valve Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety and minimize postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Valve Disease, Aortic Valve Disease, Mitral Valve Disease
- What is being tested?
- 360-degree Virtual Reality Patient Tour, State Trait Anxiety Inventory and Amsterdam Preoperative Anxiety and Information Scale
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2023to Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients awaiting elective cardiac surgery involving a sternotomy
- 18 years or older
Who cannot join
- Under the age of 18
- History of previous cardiac surgery
- (concomitant) aortic surgery
- Cardiac surgery for congenital heart defects
- Hearing or visual impairments
- Language barriers (inability to understand, speak or read Dutch)
- History of severe mental or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Center
Amsterdam, North Holland, 1105 AZ
Sulayman El Mathari, MD, +31 205668188, s.elmathari@amsterdamumc.nl
Jolanda Kluin, MD, PhD
About this study
Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety and minimize postoperative complications. Recent studies have demonstrated that Virtual Reality (VR) can function as a useful tool to diminish pre-procedural anxiety in several medical fields. Especially 360 degree VR could familiarize patients with their clinical pathway. Nevertheless, limited to no research on the application of 360 degree VR has been conducted in the context of cardiothoracic surgery yet.
Objective: The aim of this study is to explore the effects and possible benefits of 360 degree VR on pre-procedural anxiety in patients awaiting elective cardiac surgery involving a sternotomy, compared to standard forms of patient education.
Read more
Study design: Single-center, randomized controlled trial
Study population: Patients aged 18 or older awaiting elective cardiac surgery involving a sternotomy.
Read the detailed description
Patients undergoing cardiothoracic surgery are inclined to experience a form of pre-procedural anxiety. Not only can these feelings of concern cause huge psychological discomfort for patients awaiting surgery, but this can also translate into somatic complications, especially for patients with coronary artery disease. These adverse events include a prolonged recovery time, increased risk of re-hospitalization and death amongst other implications and underline the necessity of addressing pre-procedural anxiety. Several approaches have been introduced in an attempt to contain these feelings of concern. Examples that have been applied in the field of surgery include pharmacological interventions as well as extensive patient education. Especially the latter has recently been proven to be effective in diminishing pre-procedural anxiety.
A recent study highlighted the significance of 360-degree Virtual Reality patient education in limiting pre-procedural anxiety levels in patients undergoing percutaneous atrial septal closure. Their research demonstrated that thorough patient education using VR could prevent elevated scores of anxiety, possibly contributing to a diminished number of adverse events in this patient group. Alongside this study, several other researches have hinted at success or are investigating the benefit of VR in managing anxiety levels.
Considering these promising results, the aim of the VR Patient Journey Trial is to evaluate the additional value of 360-degree Virtual Reality as a new modality in reducing pre-procedural anxiety in comparison with regular forms of patient education in patients undergoing coronary artery bypass grafting (CABG) procedures. This procedure remains the most performed type of cardiac surgery and accounts for a large homogenous patient group; an estimated 85% of procedures concern isolated CABG. Managing anxiety levels in this patient group can therefore greatly impact the overall level of patient well-being in cardiac surgery.
- Conditions
- Cardiac Valve Disease, Aortic Valve Disease, Mitral Valve Disease, Tricuspid Valve Disease
- Being tested
- 360-degree Virtual Reality Patient Tour, State Trait Anxiety Inventory, Amsterdam Preoperative Anxiety and Information Scale
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
360-degree Virtual Reality Patient TourBehavioural
A 360-degree video that encompasses the entire clinical pathway. Patients are able to familiarize themselves with the hospital settings (nursery ward, operating room, intensive care unit).
State Trait Anxiety InventoryDiagnostic test
Also called STAI
Spielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety.
Amsterdam Preoperative Anxiety and Information ScaleDiagnostic test
Also called APAIS
This validated questionnaire provides insight in the presence of anxiety. It also measures the need for information.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | This patient group received A standard form of patient education, consisting of oral information and an informative flyer during their outpatient clinic visit. After this visit, patients were asked to fill out 2 validated questionnaires: Spielberger's State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS).
1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again. Receives: Diagnostic Test: State Trait Anxiety Inventory; Diagnostic Test: Amsterdam Preoperative Anxiety and Information Scale |
| Intervention group - VR | Experimental | This patient group first received a standard form of patient education, consisting of oral information and an informative flyer. Additionally, patients watched a 360-degree VR Tour using a Pico G2 4K VR headset, describing their entire clinical pathway in more detail.
After this visit, patients were asked to fill out 2 validated questionnaires: Spielberger's State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS).
1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again. Receives: Behavioral: 360-degree Virtual Reality Patient Tour; Diagnostic Test: State Trait Anxiety Inventory; Diagnostic Test: Amsterdam Preoperative Anxiety and Information Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Anxiety at baseline
State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during outpatient clinic visit prior to surgery. Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Measured: During outpatient clinic visit, prior to surgery
Trait-Anxiety at baseline
Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during outpatient clinic visit prior to surgery. Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Measured: During outpatient clinic visit, prior to surgery
Trait-Anxiety at follow-up
Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during admission to hospital (1 day prior to surgery). Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Measured: 1 day prior to surgery
State-Anxiety at follow-up
State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during admission to hospital (1 day prior to surgery). Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Measured: 1 day prior to surgery
Need-for-information at baseline
Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
Measured: During outpatient clinic visit, prior to surgery
Need-for-information at follow-up
Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
Measured: 1 day prior to surgery
Pre-procedural anxiety at baseline
Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
Measured: During outpatient clinic visit, prior to surgery
Pre-procedural anxiety at follow-up
Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
Measured: 1 day prior to surgery
HR at baseline
Heartrate in bpm (beats per minute) during outpatient clinic visit prior to surgery
Measured: During outpatient clinic visit, prior to surgery
HR at follow-up
Heartrate in bpm (beats per minute) during admission to hospital (1 day prior to surgery)
Measured: 1 day prior to surgery
HR in operation room
Heartrate in bpm (beats per minute) in the operation room on the day of surgery
Measured: in the OR on the day of surgery
Diastolic blood pressure at baseline
Diastolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery
Measured: During outpatient clinic visit prior to surgery
Systolic blood pressure at baseline
Systolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery
Measured: During outpatient clinic visit prior to surgery
Diastolic blood pressure at follow-up
Diastolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)
Measured: 1 day prior to surgery
Systolic blood pressure at follow-up
Systolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)
Measured: 1 day prior to surgery
Diastolic blood pressure in OR
Systolic blood pressure (in mm/Hg) in the operation room on the day of surgery
Measured: in the OR on the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Jul 2023
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Model description
- This prospective, single-center, randomized controlled trial (RCT) includes patients awaiting elective open heart surgery via a sternotomy. Patients who met the inclusion criteria were invited to participate in the study. Patients were allocated randomly to either the control or intervention group. The control group received oral information from the treating cardiothoracic surgeon. The intervention group received additional information through an educational 360-degree semi-immersive Virtual Reality (VR) Tour. The VR Tour provided patients a comprehensive visual experience of the entire clinical pathway of the scheduled surgical procedure, Patients complete two validated questionnaires immediately following their outpatient clinic visit to assess pre-procedural anxiety. This data was considered the 'baseline'. One day prior to the surgery, during the hospital admission, patients are asked to complete the same questionnaires again. This data will be referred to as 'follow-up (FU)'.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jolanda Kluin, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jolanda Kluin, MD, PhD, Principal investigator, j.kluin@amsterdamumc.nl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001489
- Sponsor's protocol ID
- NL2023.22.265
- Status last verified
- Jul 2024
- First submitted
- 14 Aug 2023
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: When asked for, a construction will be made to share data. At the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy
- ClinicalTrials.gov ID
- NCT06001489
- Acronym / sponsor ID
- NL2023.22.265
- Conditions
- Cardiac Valve Disease, Aortic Valve Disease, Mitral Valve Disease, Tricuspid Valve Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Aug 2023 (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.
Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety and minimize postoperative complications. Recent studies have demonstrated that Virtual Reality (VR) can function as a useful tool to diminish pre-procedural anxiety in several medical fields. Especially 360 degree VR could familiarize patients with their clinical pathway. Nevertheless, limited to no research on the application of 360 degree VR has been conducted in the context of cardiothoracic surgery yet.
Objective: The aim of this study is to explore the effects and possible benefits of 360 degree VR on pre-procedural anxiety in patients awaiting elective cardiac surgery involving a sternotomy, compared to standard forms of patient education.
Study design: Single-center, randomized controlled trial
Study population: Patients aged 18 or older awaiting elective cardiac surgery involving a sternotomy.
Detailed description
Patients undergoing cardiothoracic surgery are inclined to experience a form of pre-procedural anxiety. Not only can these feelings of concern cause huge psychological discomfort for patients awaiting surgery, but this can also translate into somatic complications, especially for patients with coronary artery disease. These adverse events include a prolonged recovery time, increased risk of re-hospitalization and death amongst other implications and underline the necessity of addressing pre-procedural anxiety. Several approaches have been introduced in an attempt to contain these feelings of concern. Examples that have been applied in the field of surgery include pharmacological interventions as well as extensive patient education. Especially the latter has recently been proven to be effective in diminishing pre-procedural anxiety.
A recent study highlighted the significance of 360-degree Virtual Reality patient education in limiting pre-procedural anxiety levels in patients undergoing percutaneous atrial septal closure. Their research demonstrated that thorough patient education using VR could prevent elevated scores of anxiety, possibly contributing to a diminished number of adverse events in this patient group. Alongside this study, several other researches have hinted at success or are investigating the benefit of VR in managing anxiety levels.
Considering these promising results, the aim of the VR Patient Journey Trial is to evaluate the additional value of 360-degree Virtual Reality as a new modality in reducing pre-procedural anxiety in comparison with regular forms of patient education in patients undergoing coronary artery bypass grafting (CABG) procedures. This procedure remains the most performed type of cardiac surgery and accounts for a large homogenous patient group; an estimated 85% of procedures concern isolated CABG. Managing anxiety levels in this patient group can therefore greatly impact the overall level of patient well-being in cardiac surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This prospective, single-center, randomized controlled trial (RCT) includes patients awaiting elective open heart surgery via a sternotomy. Patients who met the inclusion criteria were invited to participate in the study. Patients were allocated randomly to either the control or intervention group. The control group received oral information from the treating cardiothoracic surgeon. The intervention group received additional information through an educational 360-degree semi-immersive Virtual Reality (VR) Tour. The VR Tour provided patients a comprehensive visual experience of the entire clinical pathway of the scheduled surgical procedure, Patients complete two validated questionnaires immediately following their outpatient clinic visit to assess pre-procedural anxiety. This data was considered the 'baseline'. One day prior to the surgery, during the hospital admission, patients are asked to complete the same questionnaires again. This data will be referred to as 'follow-up (FU)'.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Diagnostic Test: State Trait Anxiety Inventory, Diagnostic Test: Amsterdam Preoperative Anxiety and Information ScaleThis patient group received A standard form of patient education, consisting of oral information and an informative flyer during their outpatient clinic visit. After this visit, patients were asked to fill out 2 validated questionnaires: Spielberger's State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). 1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again. |
| Intervention group - VR | Experimental | Behavioral: 360-degree Virtual Reality Patient Tour, Diagnostic Test: State Trait Anxiety Inventory, Diagnostic Test: Amsterdam Preoperative Anxiety and Information ScaleThis patient group first received a standard form of patient education, consisting of oral information and an informative flyer. Additionally, patients watched a 360-degree VR Tour using a Pico G2 4K VR headset, describing their entire clinical pathway in more detail. After this visit, patients were asked to fill out 2 validated questionnaires: Spielberger's State-Trait Anxiety Inventory (STAI) and the Amsterdam Preoperative Anxiety and Information Scale (APAIS). 1 day prior to surgery, during admission to the hospital, patients were asked to fill out the STAI and APAIS again. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients awaiting elective cardiac surgery involving a sternotomy
- 18 years or older
Key exclusion criteria (7 listed)
- Under the age of 18
- History of previous cardiac surgery
- (concomitant) aortic surgery
- Cardiac surgery for congenital heart defects
- Hearing or visual impairments
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 |
|---|---|---|
| 360-degree Virtual Reality Patient TourA 360-degree video that encompasses the entire clinical pathway. Patients are able to familiarize themselves with the hospital settings (nursery ward, operating room, intensive care unit). | Behavioural | Intervention group - VR |
| State Trait Anxiety InventoryAlso: STAISpielberger's State Trait Anxiety Inventory provides insight in the presence of anxiety. | Diagnostic test | Control group, Intervention group - VR |
| Amsterdam Preoperative Anxiety and Information ScaleAlso: APAISThis validated questionnaire provides insight in the presence of anxiety. It also measures the need for information. | Diagnostic test | Control group, Intervention group - VR |
Primary outcome
State-Anxiety at baseline
Time frame: During outpatient clinic visit, prior to surgery
State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during outpatient clinic visit prior to surgery. Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Trait-Anxiety at baseline
Time frame: During outpatient clinic visit, prior to surgery
Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during outpatient clinic visit prior to surgery. Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Trait-Anxiety at follow-up
Time frame: 1 day prior to surgery
Trait Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during admission to hospital (1 day prior to surgery). Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
State-Anxiety at follow-up
Time frame: 1 day prior to surgery
State Anxiety (derived from Spielberger's State-Trait Anxiety Inventory) during admission to hospital (1 day prior to surgery). Minimum score value 0, maximum score value 63. Lower outcome means less anxiety, higher outcome means worse anxiety.
Need-for-information at baseline
Time frame: During outpatient clinic visit, prior to surgery
Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
Need-for-information at follow-up
Time frame: 1 day prior to surgery
Need for information (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
Pre-procedural anxiety at baseline
Time frame: During outpatient clinic visit, prior to surgery
Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
Pre-procedural anxiety at follow-up
Time frame: 1 day prior to surgery
Pre-procedural anxiety (derived from Amsterdam Preoperative Anxiety and Information Scale) during outpatient clinic visit prior to surgery. Minimum score value 4, maximum value 20. Lower outcome means less anxiety, higher outcome means worse anxiety.
HR at baseline
Time frame: During outpatient clinic visit, prior to surgery
Heartrate in bpm (beats per minute) during outpatient clinic visit prior to surgery
HR at follow-up
Time frame: 1 day prior to surgery
Heartrate in bpm (beats per minute) during admission to hospital (1 day prior to surgery)
HR in operation room
Time frame: in the OR on the day of surgery
Heartrate in bpm (beats per minute) in the operation room on the day of surgery
Diastolic blood pressure at baseline
Time frame: During outpatient clinic visit prior to surgery
Diastolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery
Systolic blood pressure at baseline
Time frame: During outpatient clinic visit prior to surgery
Systolic blood pressure (in mm/Hg) during outpatient clinic visit prior to surgery
Diastolic blood pressure at follow-up
Time frame: 1 day prior to surgery
Diastolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)
Systolic blood pressure at follow-up
Time frame: 1 day prior to surgery
Systolic blood pressure (in mm/Hg) during admission to hospital (1 day prior to surgery)
Diastolic blood pressure in OR
Time frame: in the OR on the day of surgery
Systolic blood pressure (in mm/Hg) in the operation room on the day of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: Undecided. When asked for, a construction will be made to share data. At the end of the study.
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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.
Jolanda Kluin, MD, PhD principal investigator
j.kluin@amsterdamumc.nl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 360-degree Virtual Reality Patient Tour, State Trait Anxiety Inventory and Amsterdam Preoperative Anxiety and Information Scale in people with Cardiac Valve Disease and Aortic Valve Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 2 inclusion and 7 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 10 Jul 2024. 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 Netherlands. 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 Sulayman el Mathari, MD (+31628156982, s.elmathari@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Anxiety at baseline (time frame: During outpatient clinic visit, prior to surgery). The study lists 16 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 10 Jul 2024.