Anxiety and FearNCT04406181
Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic
A study testing HADS and a survey in people with Anxiety and Fear and Anxiety Depression, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The effect and impact of postponing cardiac surgery / creating a waiting list as a result of COVID-19 on patients, both psychologically and symptomatically on three groups of patients: 1. The degree of anxiety and/or depression induced by their altered medical care trajectory. 2. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anxiety and Fear, Anxiety Depression, Anxiety Postoperative
- What is being tested?
- HADS and a survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 18 May 2020to 1 Jan 2021
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients whose operation date has been deferred due to the pandemic COVID-19.
- All patients who did not have had an operation date before the pandemic COVID-19.
- All patients who have been operating on during the month before the pandemic COVID-19.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
universitair Ziekenhuis Brussel
Jette, Vlaams Brabant, 1090
Veerle Van Mossevelde, +3224763134, veerle.vanmossevelde@uzbrussel.be
About this study
Official title: Effect on the COVID-19 Pandemic-induced Reduction in Elective Surgery on Medical Events and Psychological Well-being of Patients Waiting for Cardiac Surgery
The effect and impact of postponing cardiac surgery / creating a waiting list as a result of COVID-19 on patients, both psychologically and symptomatically on three groups of patients:
- The degree of anxiety and/or depression induced by their altered medical care trajectory.
- The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit
- The occurrence of reduced access to medical and psychological help
Read the detailed description
A prospective study by means of a questionnaire, specifically designed for each of the three groups.
- Adult patients whose operation date has been deferred
- Patients who did not have had an operation date
- Patients who have been operating on during the month before
Each group will receive a twofold questionnaire:
Part I: Hospital Anxiety and Depression Scale (HADS), a robust questionnaire used for hospitalized and non-hospitalized patients gauging the degree of anxiety and/or depression, irrespective of their specific medical condition. All three groups receive the same list of questions.
-Part II: a questionnaire made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak. Each of the three groups will receive a questionnaire, adapted to the group they are assigned to.
The questionnaires will be delivered by the use of Qualtrics or on paper. Timing and mode of presentation (Qualtrics or fill-in paper on admission) of the questionnaire will depend on the length of the quarantine measures.
- Being tested
- HADS, a survey
- Keywords
- cardiac surgery, postoperative consultation, postponed elective surgery, COVID-19
- Medical subject headings
- Anxiety Disorders, Stress, Psychological, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HADSBehavioural
Also called questionnaire
Hospital Anxiety and Depression Scale
a surveyBehavioural
made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak
| Study group | Role | What they receive |
|---|---|---|
| operation deferred | Other | Adult patients whose operation date has been deferred due to the pandemic Receives: Behavioral: HADS; Behavioral: a survey |
| no operation date | Other | Patients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started Receives: Behavioral: HADS; Behavioral: a survey |
| postoperative consultation deferred | Other | Patients who have been operating on during the month before the pandemic Receives: Behavioral: HADS; Behavioral: a survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)
The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Measured: 10 minutes
Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit
The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.
Measured: 10 minutes
Reduced access to medical and psychological help
The occurrence of reduced access to medical and psychological help by means of an adjusted survey.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start18 May 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Jan Nijs, MD, Principal investigator, Universitair Ziekenhuis BrusselMark La Meir, Phd, MD, Study director, Universitair Ziekenhuis BrusselAshley Welch, MD, Study chair, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406181
- Sponsor's protocol ID
- COVID-19 Cardiac psy wellbeing
- Status last verified
- May 2020
- First submitted
- 28 Apr 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect on the COVID-19 Pandemic-induced Reduction in Elective Surgery on Medical Events and Psychological Well-being of Patients Waiting for Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04406181
- Acronym / sponsor ID
- COVID-19 Cardiac psy wellbeing
- Keywords
- cardiac surgery, postoperative consultation, postponed elective surgery, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 28 May 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.
The effect and impact of postponing cardiac surgery / creating a waiting list as a result of COVID-19 on patients, both psychologically and symptomatically on three groups of patients:
- The degree of anxiety and/or depression induced by their altered medical care trajectory.
- The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit
- The occurrence of reduced access to medical and psychological help
Detailed description
A prospective study by means of a questionnaire, specifically designed for each of the three groups.
- Adult patients whose operation date has been deferred
- Patients who did not have had an operation date
- Patients who have been operating on during the month before
Each group will receive a twofold questionnaire:
Part I: Hospital Anxiety and Depression Scale (HADS), a robust questionnaire used for hospitalized and non-hospitalized patients gauging the degree of anxiety and/or depression, irrespective of their specific medical condition. All three groups receive the same list of questions.
-Part II: a questionnaire made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak. Each of the three groups will receive a questionnaire, adapted to the group they are assigned to.
The questionnaires will be delivered by the use of Qualtrics or on paper. Timing and mode of presentation (Qualtrics or fill-in paper on admission) of the questionnaire will depend on the length of the quarantine measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| operation deferred | Other | Behavioral: HADS, Behavioral: a surveyAdult patients whose operation date has been deferred due to the pandemic |
| no operation date | Other | Behavioral: HADS, Behavioral: a surveyPatients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started |
| postoperative consultation deferred | Other | Behavioral: HADS, Behavioral: a surveyPatients who have been operating on during the month before the pandemic |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adult patients whose operation date has been deferred due to the pandemic COVID-19.
- All patients who did not have had an operation date before the pandemic COVID-19.
- All patients who have been operating on during the month before the pandemic COVID-19.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| HADSAlso: questionnaireHospital Anxiety and Depression Scale | Behavioural | no operation date, operation deferred, postoperative consultation deferred |
| a surveymade up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak | Behavioural | no operation date, operation deferred, postoperative consultation deferred |
Primary outcome
Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)
Time frame: 10 minutes
The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit
Time frame: 10 minutes
The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.
Reduced access to medical and psychological help
Time frame: 10 minutes
The occurrence of reduced access to medical and psychological help by means of an adjusted survey.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
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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.
Jan Nijs, MD principal investigator
Universitair Ziekenhuis Brussel
Mark La Meir, Phd, MD study director
Universitair Ziekenhuis Brussel
Ashley Welch, MD study chair
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HADS and a survey in people with Anxiety and Fear and Anxiety Depression, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 3 inclusion and 1 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 1 Jun 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 Belgium. 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 Veerle Van Mossevelde, Data Nurse (+3224763134, veerle.vanmossevelde@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS) (time frame: 10 minutes). The study lists 3 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 1 Jun 2020.