Heart ConditionsNCT04766125
Psychological Factors in Cardiac Surgery
A study testing Adverse event information in people with Heart Conditions, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study investigates the effect of adverse event information on adverse event occurrence in patients undergoing elective cardiac surgery in a two-armed, randomized study. One group will receive standard information about adverse events; the second group will receive a standardised elaboration of the standard… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Conditions
- What is being tested?
- Adverse event information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Feb 2021to 12 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults (18 and older) undergoing elective cardiac surgery at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
Who cannot join
- Patients who have previously had cardiac surgery
- Cardiac surgery with deep hypothermia (<32 degrees Celsius)
- Acute surgery
- Patients with psychiatric or neurological disease who are unable to collaborate with the study protocol
- Patients who do not speak/read Danish
Trial locations and contacts
1 site in 1 country.
About this study
The study investigates the effect of adverse event information on adverse event occurrence in patients undergoing elective cardiac surgery in a two-armed, randomized study. One group will receive standard information about adverse events; the second group will receive a standardised elaboration of the standard information. Hypothesis: Elaborated information about adverse events will increase adverse event occurrence, mediated by expectations and anxiety, and moderated by coping style.
Read the detailed description
If quality assessment indicates that the protocol was not followed adequately, participants will be excluded from data analysis.
- Conditions
- Heart Conditions
- Being tested
- Adverse event information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adverse event informationBehavioural
All patients have access to the standard material about adverse events related to the surgery. One arm will additionally receive elaborated adverse event information from a nurse and a surgeon
| Study group | Role | What they receive |
|---|---|---|
| Standard adverse event information | Other | Not described Receives: Behavioral: Adverse event information |
| Elaborated adverse event information | Other | Not described Receives: Behavioral: Adverse event information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Measured: Assessed on day four
Secondary outcomes (4)
Number of adverse events
Measured: Assessed on day 30, 90, and 180
Intensity of experienced adverse events
Measured: Assessed on day four, 30, 90, and 180
Hospital readmission
Measured: Assessed on day 180
Occurrence of specific adverse events
Measured: Assessed on day four, 30, 90, and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start18 Feb 2021
- Primary completion15 Dec 2023
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ConditionsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Mette Sieg, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766125
- Sponsor's protocol ID
- AUPsych
- Status last verified
- Apr 2025
- First submitted
- 18 Feb 2021
- Last updated
- 6 Apr 2025
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Factors in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04766125
- Acronym / sponsor ID
- AUPsych
- Conditions
- Heart Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 23 Feb 2021 (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 study investigates the effect of adverse event information on adverse event occurrence in patients undergoing elective cardiac surgery in a two-armed, randomized study. One group will receive standard information about adverse events; the second group will receive a standardised elaboration of the standard information. Hypothesis: Elaborated information about adverse events will increase adverse event occurrence, mediated by expectations and anxiety, and moderated by coping style.
Detailed description
If quality assessment indicates that the protocol was not followed adequately, participants will be excluded from data analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard adverse event information | Other | Behavioral: Adverse event information |
| Elaborated adverse event information | Other | Behavioral: Adverse event information |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (18 and older) undergoing elective cardiac surgery at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
Key exclusion criteria (5 listed)
- Patients who have previously had cardiac surgery
- Cardiac surgery with deep hypothermia (<32 degrees Celsius)
- Acute surgery
- Patients with psychiatric or neurological disease who are unable to collaborate with the study protocol
- Patients who do not speak/read Danish
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 |
|---|---|---|
| Adverse event informationAll patients have access to the standard material about adverse events related to the surgery. One arm will additionally receive elaborated adverse event information from a nurse and a surgeon | Behavioural | Elaborated adverse event information, Standard adverse event information |
Primary outcome
Number of adverse events
Time frame: Assessed on day four
4 secondary outcomes
Number of adverse events
Time frame: Assessed on day 30, 90, and 180
Intensity of experienced adverse events
Time frame: Assessed on day four, 30, 90, and 180
Hospital readmission
Time frame: Assessed on day 180
Occurrence of specific adverse events
Time frame: Assessed on day four, 30, 90, and 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- 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.
Mette Sieg principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adverse event information in people with Heart Conditions, run by University of Aarhus at 1 site in Denmark.
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 5 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: finished, as of the sponsor's last update on 6 Apr 2025. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Assessed on day four). 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 6 Apr 2025.