Trials / Completed
CompletedNCT05896982
Optimizing Patient Experience During Myocardial Perfusion Imaging
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- Tilburg University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The present study focusses on the effects of the diagnostic testing environment on psychological wellbeing, cardiac symptoms and patient satisfaction during cardiac stress testing (CST) in patients who are referred to the Institute Verbeeten for SPECT myocardial perfusion imaging (MPI). The diagnostic procedure consists of two days of MPI using SPECT: day 1 of MPI involves obtaining a resting image and day 2 (typically 3 or 4 days later) a stress MPI following exercise or pharmacological challenge with adenosine. The diagnostic procedure can result in undesirable effects on psychological wellbeing, such as anxiety or psychological distress. These effects can be related to anticipatory anxiety (day 1 of MPI) and/or responses to the exercise or adenosine stress testing (day 2 of MPI). The present investigation aims to develop methods to further improve patients' experiences and wellbeing during the diagnostic process for the presence of inducible myocardial ischemia. This research project will compare four groups to establish the effect of providing information and supportive coaching: (1) care as usual, (2) information support using video materials, (3) supportive coaching during the diagnostic testing procedure, and (4) a combination of both interventions. The video-based information and supportive coaching are aimed at reducing feelings of anxiety, uncertainty and psychological distress during the diagnostic testing procedure. In addition to standardized self-report questionnaires, this project will utilize facial expression analysis software to measure emotional states during CST as well as 24- hour ambulatory assessments to evaluate autonomic nervous system activity, cardiac symptoms and psychological wellbeing during everyday life activities in the period between the two days of MPI. It is hypothesized that additional video-based information and supportive coaching during the diagnostic process for the inducibility of myocardial ischemia will result in improved psychological wellbeing (reduced acute negative emotions; primary outcome) as well as less cardiac and other physical symptoms and improved patient satisfaction (secondary outcomes) of the diagnostic clinic visit. The innovative aspect of the present proposal is its focus on emotional expression during evaluation for myocardial ischemia using FaceReader software in combination with self-reported momentary mood and perceived stress assessments. Knowledge about the interaction between psychological wellbeing and cardiac function obtained in this project will strengthen the development of future interventions aimed to reduce symptom burden and psychological distress in patients undergoing diagnostic evaluations for heart disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Care as usual with information support | Comprises of additional visual information in the form of two videos that show details about the procedure on both days of the MPI diagnostic procedure. Each of these two videos are approximately 5 minutes long and are made available to the patients before the first day (video 1), and in between the first and second day (video 2). |
| OTHER | Care as usual with supportive coaching | Patients receive coaching from one person who is present throughout the complete diagnostic process. The coach is available for answering questions as well as comforting the patients when necessary (e.g., to reassure patients if they are anxious or stressed). |
| OTHER | Care as usual with information support and supportive coaching | This intervention comprises additional visual information in the form of two videos and coaching throughout the diagnostic process as described above. |
Timeline
- Start date
- 2022-11-02
- Primary completion
- 2024-02-05
- Completion
- 2024-06-01
- First posted
- 2023-06-09
- Last updated
- 2025-08-27
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT05896982. Inclusion in this directory is not an endorsement.