Visual and auditory hallucinations following cardiac surgery

ISRCTN ISRCTN18368253
DOI https://doi.org/10.1186/ISRCTN18368253
Secondary identifying numbers VAACS-2022-CORE01
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Dr Haitham Abu Khadija
Principal Investigator

P.O. Box 1, Derech Pasternak 1
Rehovot
76100
Israel

ORCiD logoORCID ID 0000-0002-2336-3125
Phone +972 0526391486
Email haithamab1@clalit.org.il
Dr Mohammad Alnees
Public, Scientific, Principal Investigator

Al , Awda Street
Bethlehem
P400
Palestine, State of

ORCiD logoORCID ID 0000-0002-5577-8499
Phone +970 0599240098
Email S11743633@stu.najah.edu
Dr Nizar Abu Hamdeh
Principal Investigator

Al , Awda Street
Bethlehem
P400
Palestine, State of

ORCiD logoORCID ID 0009-0000-4209-0137
Phone +972 59-590-2745
Email s12042043@stu.najah.edu
Dr Abdalaziz Darwish
Principal Investigator

rafidia
nablus
P400
Palestine, State of

ORCiD logoORCID ID 0000-0002-3231-3672
Phone +972 59-202-6839
Email abdalaziz.darwish@najah.edu
Dr Duha Najajra
Principal Investigator

Beit Hanina
Jerusalem
90805
Israel

ORCiD logoORCID ID 0009-0007-3561-2380
Phone +972 52-643-6745
Email s12240420@stu.najah.edu

Study information

Study designProspective cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther, Quality of life, Treatment, Safety
Participant information sheet Patient information material can be found at https://docs.google.com/document/d/1jSCuKhPGwXlrQOr_iHapECnAfZQaD57I/edit?usp=sharing&ouid=111127472982961654536&rtpof=true&sd=true
Scientific titleVAACS study: predictors and outcomes of visual and auditory hallucinations following coronary artery bypass grafting and valve replacement surgery – a prospective multicenter cohort
Study acronymVAACS
Study objectivesTo 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) studiedPostoperative neuropsychiatric complications, visual hallucinations, auditory hallucinations, cardiac surgery, cognitive dysfunction.
InterventionThis 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 typeOther
Primary outcome measureOccurrence of postoperative visual and auditory hallucinations measured using the QPE tool within 7 days of surgery.
Secondary outcome measuresHallucination severity measured using the Questionnaire for Psychotic Experiences (QPE) severity scale within 7 days of surgery.
Overall study start date12/09/2022
Completion date30/06/2025

Eligibility

Participant type(s)Patient
Age groupMixed
Lower age limit18 Years
Upper age limit100 Years
SexBoth
Target number of participants1600
Total final enrolment1332
Key inclusion criteria1. Adults aged 18 years or older
2. Scheduled for elective or semi-elective cardiac surgery (either isolated CABG or valvular surgery)
Key exclusion criteria1. 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 enrolment20/09/2022
Date of final enrolment30/06/2025

Locations

Countries of recruitment

  • Palestine, State of

Study participating centre

Palestinian Clinical Research Center
-
Bethlehem
P400
Palestine, State of

Sponsor information

An-Najah National University
University/education

Nablus-Rafidia, Qasrawi Street
Nablus
00970
Palestine, State of

Phone +9709238900
Email info@najah.edu
Website https://www.najah.edu/en/academic/faculties/
ROR logo "ROR" https://ror.org/0046mja08
Palestinian Clinical Research Center
Other

Al , Awda Street
Bethlehem
90435
Palestine, State of

Phone +972 55-560-4917
Email researchcenterpalestinianclini@gmail.com
Website https://www.facebook.com/share/19R5NRuZUd/?mibextid=wwXIfr

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/01/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request, Published as a supplement to the results publication
Publication and dissemination planResults from this study will be published in peer-reviewed medical journals and presented at national and international scientific conferences. Authorship will follow established international guidelines (ICMJE criteria). Additionally, a simplified summary of findings will be prepared and shared with relevant patient groups, clinicians, and healthcare policymakers.
IPD sharing planAnonymised 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?
Protocol file 28/07/2025 No No

Additional files

47709 Study Protocol.pdf

Editorial Notes

22/07/2025: Study's existence confirmed by the Institutional Review Board (IRB) at An-Najah National University.