Visual and auditory hallucinations following cardiac surgery
| ISRCTN | ISRCTN18368253 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18368253 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | VAACS-2022-CORE01 |
| Sponsors | An-Najah National University, Palestinian Clinical Research Center |
| Funder | Investigator initiated and funded |
- Submission date
- 22/07/2025
- Registration date
- 29/07/2025
- Last edited
- 28/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Patients undergoing major heart surgeries such as coronary artery bypass grafting (CABG) or valvular surgery sometimes experience hallucinations after their operation, meaning they might see or hear things that are not real. These hallucinations can cause stress, slow down recovery, and negatively impact overall well-being. This research aims to identify why these hallucinations occur and if certain factors, such as gender (male or female), type of surgery, medical history, mechanical ventilation duration, kidney function, or medications used during and after surgery, increase the risk. The study is specifically interested in understanding if CABG and valvular surgery have different risk factors.
Who can participate?
Adult patients who have had heart surgery across multiple hospitals in Palestine.
What does the study involve?
Patients will be monitored closely for the first 7 days after surgery to record whether they experience any visual or auditory hallucinations.
What are the possible benefits and risks of participating?
The main goal is to help healthcare professionals identify which patients are at higher risk, allowing better preparation, closer monitoring, and improved care after heart surgery. The results could also lead to strategies that help reduce these disturbing experiences, making recovery smoother and improving patients' quality of life.
Participation involves minimal risk. The study requires patients to answer questions about their experiences post-surgery and allows access to their clinical data. Some may find questions about hallucinations distressing. Participation is voluntary, and participants may withdraw at any time without impact on their care.
Where is the study run from?
Palestinian Clinical Research Center, Palestine
When is the study starting and how long is it expected to run for?
September 2022 to June 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mahammad Alnees, a2011z2012z2013@gmail.com
Contact information
Principal investigator
P.O. Box 1, Derech Pasternak 1
Rehovot
76100
Israel
 ORCID ID |
0000-0002-2336-3125 |
|---|---|
| Phone | +972 0526391486 |
| haithamab1@clalit.org.il |
Public, Scientific, Principal investigator
Al , Awda Street
Bethlehem
P400
Palestine, State of
| ORCID ID |
0000-0002-5577-8499 |
|---|---|
| Phone | +970 0599240098 |
| S11743633@stu.najah.edu |
Principal investigator
Al , Awda Street
Bethlehem
P400
Palestine, State of
| ORCID ID |
0009-0000-4209-0137 |
|---|---|
| Phone | +972 59-590-2745 |
| s12042043@stu.najah.edu |
Principal investigator
rafidia
nablus
P400
Palestine, State of
| ORCID ID |
0000-0002-3231-3672 |
|---|---|
| Phone | +972 59-202-6839 |
| abdalaziz.darwish@najah.edu |
Principal investigator
Beit Hanina
Jerusalem
90805
Israel
| ORCID ID |
0009-0007-3561-2380 |
|---|---|
| Phone | +972 52-643-6745 |
| s12240420@stu.najah.edu |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | VAACS study: predictors and outcomes of visual and auditory hallucinations following coronary artery bypass grafting and valve replacement surgery – a prospective multicenter cohort |
| Study acronym | VAACS |
| Study objectives | To estimate the incidence and identify independent predictors of visual and auditory hallucinations in the early postoperative period following CABG or valve surgery. |
| Ethics approval(s) |
Approved 12/09/2022, Institutional Review Board (IRB) at An-Najah National University (Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, 44839, Palestine, State of; +970 9 2345113; s11743633@stu.najah.edu), ref: 2022/8 |
| Health condition(s) or problem(s) studied | Postoperative neuropsychiatric complications, visual hallucinations, auditory hallucinations, cardiac surgery, cognitive dysfunction. |
| Intervention | This is a prospective observational cohort study. Participants undergoing CABG or valve surgery were screened and enrolled postoperatively. Data collection included: * Daily assessment of hallucinations using the Questionnaire for Psychotic Experiences (QPE) for up to 7 days post-surgery or until discharge (whichever comes first). * Collection of clinical, demographic, medication, and perioperative data. * No interventions were administered beyond routine clinical care. Total observation period: up to 7 days. Total follow-up: until hospital discharge. |
| Intervention type | Other |
| Primary outcome measure(s) | Occurrence of postoperative visual and auditory hallucinations measured using the QPE tool within 7 days of surgery. |
| Key secondary outcome measure(s) | Hallucination severity measured using the Questionnaire for Psychotic Experiences (QPE) severity scale within 7 days of surgery. |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 1600 |
| Total final enrolment | 1332 |
| Key inclusion criteria | 1. Adults aged 18 years or older 2. Scheduled for elective or semi-elective cardiac surgery (either isolated CABG or valvular surgery) |
| Key exclusion criteria | 1. Inability to provide informed consent or complete the questionnaire (e.g. language barrier or severe cognitive impairment) 2. Known history of major psychiatric or neurological disorders that could confound hallucination assessment (such as schizophrenia or dementia) 3. Parkinson’s disease 4. Blindness (precluding visual hallucinations assessment) 5. Active alcohol or substance abuse 6. Clinical diagnosis of delirium at the time of screening 7. Pre-existing chronic hallucinations or psychotic disorders 8. Emergency surgery cases 9. Patients on mechanical circulatory support, given their distinct risk profiles for neuropsychiatric complications |
| Date of first enrolment | 20/09/2022 |
| Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- Palestine, State of
Study participating centre
Bethlehem
P400
Palestine, State of
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| IPD sharing plan | Anonymised participant data that support the findings of this study will be available upon reasonable request after publication of primary results. Data requests must be accompanied by a clear scientific rationale, approved study protocol, and a signed data-sharing agreement. Requests can be submitted directly to the corresponding author/principal investigator, Dr Mahammad Alnees, a2011z2012z2013@gmail.com. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 28/07/2025 | No | No |
Additional files
Editorial Notes
22/07/2025: Study's existence confirmed by the Institutional Review Board (IRB) at An-Najah National University.
