A study investigating symptom changes and experiences in patients with mental and physical illnesses undergoing surgery

A Single-center Prospective Cohort Study of Perioperative Adaptation, Decision Making, and Experience in Surgical Patients With Mental Disorders - PADME Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030260078

Enrollment

120

Registered

2026-04-23

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Procedures, Operative

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals scheduled to undergo general surgical or orthopedic surgery under general anesthesia. 2. Individuals aged 18 years or older. 3. Individuals from whom voluntary informed consent to participate in this study has been obtained from the participant or a legally authorized representative, following adequate explanation and sufficient understanding of the study.

Exclusion criteria

Exclusion criteria: 1. Individuals who, at the time of admission, are diagnosed with mental disorders in the category of neurocognitive disorders, including delirium and dementia, based on the International Classification of Diseases, 11th Revision (ICD-11). 2. Individuals with intellectual developmental disorder of severe or profound severity, based on ICD-11. 3. Individuals otherwise judged by the principal investigator to be unsuitable for participation in the study.

Design outcomes

Primary

Measure	Time frame
1. Failure to cooperate with medical recommendations (FCMR) (1) self removal of medical devices such as intravenous lines, urinary catheters, and nasogastric tubes; (2) deviation from prescribed bed rest; (3) self inflicted injury to the surgical site, including self removal of a stoma; (4) refusal of surgery or discharge against medical advice before completion of treatment; and (5) any other behavior judged by the attending surgeon to be contrary to the recommended medical care. 2. Worsening of perioperative psychiatric symptoms assessed using the BE-PSD-V2.0, BFCRS, and 3D-CAM. 3. Quantitative and qualitative data on perioperative experiences including quantitative data obtained using an 11 point Likert scale and qualitative data.	—

Measure

Time frame

1. Failure to cooperate with medical recommendations (FCMR) (1) self removal of medical devices such as intravenous lines, urinary catheters, and nasogastric tubes; (2) deviation from prescribed bed rest; (3) self inflicted injury to the surgical site, including self removal of a stoma; (4) refusal of surgery or discharge against medical advice before completion of treatment; and (5) any other behavior judged by the attending surgeon to be contrary to the recommended medical care. 2. Worsening of perioperative psychiatric symptoms assessed using the BE-PSD-V2.0, BFCRS, and 3D-CAM. 3. Quantitative and qualitative data on perioperative experiences including quantitative data obtained using an 11 point Likert scale and qualitative data.

—

Secondary

Measure	Time frame
1. Medical Outcomes Study General Adherence Items; expression of agitation/aggression, expression of suicidal ideation, need for persuasion not amounting to FCMR; implementation of behavioral restrictions 2. Dose escalation or new prescription of psychotropic medications, change in legal admission status, and frequency of as needed medication use	—

Contacts

Public ContactHiroyasu Ino

Tokyo Metropolitan Matsuzawa Hospital

hiro.ino.research@gmail.com+81-3-3303-7211

Outcome results