UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061686 |
|---|---|
| Receipt number | R000070585 |
| Scientific Title | Prevalence and Clustering of Five Common Symptoms (Pain, Thirst, Dyspnea, Anxiety, Sleep Disturbance) in ICU Patients after Elective Surgery or Catheter Intervention: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/05/26 |
| Last modified on | 2026/05/26 03:49:04 |
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Basic information
Public title
Prevalence and Clustering of Five Common Symptoms (Pain, Thirst, Dyspnea, Anxiety, Sleep Disturbance) in ICU Patients after Elective Surgery or Catheter Intervention: A Prospective Observational Study
Acronym
Prevalence and Clustering of Five Common Symptoms (Pain, Thirst, Dyspnea, Anxiety, Sleep Disturbance) in ICU Patients after Elective Surgery or Catheter Intervention: A Prospective Observational Study
Scientific Title
Prevalence and Clustering of Five Common Symptoms (Pain, Thirst, Dyspnea, Anxiety, Sleep Disturbance) in ICU Patients after Elective Surgery or Catheter Intervention: A Prospective Observational Study
Scientific Title:Acronym
Prevalence and Clustering of Five Common Symptoms (Pain, Thirst, Dyspnea, Anxiety, Sleep Disturbance) in ICU Patients after Elective Surgery or Catheter Intervention: A Prospective Observational Study
Region
| Japan |
Condition
Condition
ICU Patients after Elective Surgery or Catheter Intervention
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine the prevalence and severity of five symptoms (pain, thirst, dyspnea, anxiety, and sleep disturbance) in ICU patients after elective surgery or catheter intervention, and to explore factors associated with symptom occurrence (e.g., age, type of surgery).
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to evaluate the co-occurrence and cluster formation among these five symptoms.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence and severity of five symptoms (pain, thirst, dyspnea, anxiety, and sleep disturbance) in ICU patients after elective surgery or catheter intervention
Key secondary outcomes
Risk factors for each symptom
Symptom clusters
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients admitted to the ICU following elective surgery or catheter intervention who meet all of the following inclusion criteria and none of the exclusion criteria.
Inclusion Criteria:
Patients capable of self-reporting at the time of assessment, as defined by:
A Richmond Agitation-Sedation Scale (RASS) score between -1 and +1.
For non-intubated patients: A Glasgow Coma Scale (GCS) score of 14 to 15.
For intubated/non-verbal patients: A GCS score of E4VTM6, with intact orientation and the ability to communicate.
Key exclusion criteria
Patients with cognitive impairment (i.e., a documented diagnosis of dementia).
Patients who screen positive for delirium at the time of assessment (CAM-ICU positive).
Patients who have difficulty communicating in Japanese.
Patients who refuse or are unable to provide informed consent.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Horinouchi |
Organization
Hospital of the University of Occupational and Environmental Health
Division name
Department of Nursing
Zip code
807-8556
Address
1-1 Iseigaoka, Yahatanishi Ward, Kitakyushu City, Fukuoka Prefecture, Japan
TEL
093-603-1611
horinouchi.megumi327@gmail.com
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Horinouchi |
Organization
Hospital of the University of Occupational and Environmental Health
Division name
Department of Nursing
Zip code
807-8556
Address
1-1 Iseigaoka, Yahatanishi Ward, Kitakyushu City, Fukuoka Prefecture, Japan
TEL
093-603-1611
Homepage URL
horinouchi.megumi327@gmail.com
Sponsor or person
Institute
Hospital of the University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, University of Occupational and Environmental Health
Address
1-1 Iseigaoka, Yahatanishi Ward, Kitakyushu City, Fukuoka Prefecture, Japan
Tel
093-603-1611
daigakurinri@mbox.pub.uoeh-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 | 05 | Month | 26 | 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
| 2026 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients who are admitted to our ICU between May 2026 and March 2028 and meet the inclusion criteria will be consecutively enrolled until the target sample size is reached.
A single cross-sectional interview and symptom assessment will be conducted by trained nurses between 6:00 AM and 11:00 AM on the day following the surgery or catheter intervention.
Management information
Registered date
| 2026 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070585
