UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063045 |
|---|---|
| Receipt number | R000072166 |
| Scientific Title | A Feasibility Study of a Personalized Auditory Intervention for Delirium Prevention in Postoperative Cardiovascular Surgery Patients in the ICU |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/09/24 18:31:29 |
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Basic information
Public title
A Feasibility Study of a Personalized Auditory Intervention for Delirium Prevention in Intensive Care Unit Patients Following Cardiovascular Surgery
Acronym
Personalized Auditory Intervention Study
Scientific Title
A Feasibility Study of a Personalized Auditory Intervention for Delirium Prevention in Postoperative Cardiovascular Surgery Patients in the ICU
Scientific Title:Acronym
PADI-ICU Study
Region
| Japan |
Condition
Condition
Postoperative Delirium
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postoperative delirium occurs frequently after cardiovascular surgery, with an incidence ranging from 26% to 52%, and is associated with prolonged ICU stays and increased healthcare costs. Therefore, its prevention remains an important clinical challenge. Recent guidelines recommend multimodal non-pharmacological interventions, including optimization of sedation and analgesia and early mobilization, for the prevention and management of delirium. In particular, the importance of patient-centered care that takes individual backgrounds and preferences into account has been emphasized.
The ICU environment is characterized by various non-routine and unpleasant auditory stimuli, such as alarms from life-support equipment and sounds generated by medical devices, which may contribute to the development of delirium. Conversely, hearing serves as an important means for patients with limited visual input to remain connected with the external environment. Familiar and comforting auditory stimuli, such as preferred music and the voices of family members, may contribute to delirium prevention by alleviating anxiety and stress.
The purpose of this study is to develop a personalized auditory intervention program that integrates multiple auditory components based on individual patient preferences and to evaluate its safety and feasibility among postoperative cardiovascular surgery patients admitted to the ICU.
If the personalized auditory intervention program developed in this study is demonstrated to be safe and feasible for postoperative cardiovascular surgery patients in the ICU, the findings will provide foundational evidence for the development of a novel non-pharmacological intervention for delirium prevention and support future studies evaluating its effectiveness.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intervention completion rate
Key secondary outcomes
Feasibility: Intervention implementation rate, Acceptability of the intervention among nurses
Safety: Incidence of adverse events
Effectiveness: Incidence of delirium, Duration of delirium, Length of ICU stay
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A personalized auditory intervention program combining sounds selected according to individual patient preferences, including music, family voices, and natural sounds, will be administered to patients admitted to the ICU following cardiovascular surgery during their ICU stay.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo cardiovascular surgery at Saga University Hospital and admitted to the ICU after surgery.
2. Patients scheduled for open-chest surgery under general anesthesia.
3. Adults aged 18 years or older.
4. Patients who have provided written informed consent to participate in this study.
Key exclusion criteria
1. Patients undergoing emergency surgery.
2. Patients with severe preexisting cognitive impairment (i.e., those diagnosed with dementia).
3. Patients who have significant difficulty communicating through normal conversation, even with the use of hearing-assistive devices such as hearing aids.
4. Patients deemed unsuitable for participation in the study by the attending physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yamada |
| Middle name | |
| Last name | Haruna |
Organization
Saga University
Division name
Department of Nursing, Faculty of Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga, Saga
TEL
0952-34-2549
f0115@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Yamada |
| Middle name | |
| Last name | Haruna |
Organization
Saga University
Division name
Department of Nursing, Faculty of Medicine
Zip code
8498501
Address
5-1-1 Nabeshima, Saga, Saga
TEL
0952-34-2549
Homepage URL
f0115@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Japan Academy of Critical Care Nursing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University
Address
5-1-1 Nabeshima, Saga, Saga
Tel
0952-34-3357
kenkyu-shinsei@ml.cc.saga-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072166
