UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053921 |
|---|---|
| Receipt number | R000061548 |
| Scientific Title | Changes in anxiety by explaining the patient clinical pathway at the admission and discharge support center |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/03/24 09:24:07 |
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Basic information
Public title
Changes in anxiety by explaining at the admission/discharge support center a plan that lists the standard schedule for the treatment, nursing care, etc. that patients receive for each surgery, such as tests, procedures, meals, and medication.
Acronym
Changes in anxiety by explaining at the admission/discharge support center a plan that lists the standard schedule for the treatment, nursing care, etc. that patients receive for each surgery, such as tests, procedures, meals, and medication.
Scientific Title
Changes in anxiety by explaining the patient clinical pathway at the admission and discharge support center
Scientific Title:Acronym
Changes in anxiety by explaining the patient clinical pathway at the admission and discharge support center
Region
| Japan |
Condition
Condition
Obstetrics and gynecology benign diseases
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conducted a questionnaire survey on how nurses explain the clinical pathway for patients to two groups of patients scheduled for surgery at the Department of Obstetrics and Gynecology at Nagasaki University Hospital. Analyze and clarify changes in anxiety and changes in patient burden due to increased explanation content. Thereby, by obtaining the patient's subjective evaluation of the clinical pathway explanation for the patient, it becomes possible to provide higher quality preoperative nursing care. Furthermore, this study provides suggestions for considering how to explain the clinical pathway to patients using ``MSC preoperative testing'' in the future.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anonymous questionnaire created independently
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Hand out the questionnaire at MSC and explain the clinical pathway for patients on the ward after admission.
Interventions/Control_2
Hand out the questionnaire at the MSC and explain the clinical pathway for the patient at the MSC before admission.
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
Female
Key inclusion criteria
Patients scheduled for obstetrics and gynecology surgery under general anesthesia or spinal anesthesia using MSC preoperative testing
Key exclusion criteria
Psychiatric ward inpatients
Patients with moderate or higher cognitive function evaluation sheet
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | TANAKA |
| Middle name | |
| Last name | MAIKO |
Organization
Nagasaki University Hospital
Division name
nursing department
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-8544
t-maiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | TANAKA |
| Middle name | |
| Last name | MAIKO |
Organization
Nagasaki University Hospital
Division name
nursing department
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
095-819-8544
Homepage URL
t-maiko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
095-819-7200
t-maiko@nagasaki-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
| 2024 | Year | 05 | 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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061548
