UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032332 |
|---|---|
| Receipt number | R000036399 |
| Scientific Title | Studies on the effect of a positive psychological intervention for the prevention of PICS |
| Date of disclosure of the study information | 2022/06/10 |
| Last modified on | 2018/04/20 17:14:44 |
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Basic information
Public title
Studies on the effect of a positive psychological intervention for the prevention of PICS
Acronym
Positive psychological intervention for PICS prevention
Scientific Title
Studies on the effect of a positive psychological intervention for the prevention of PICS
Scientific Title:Acronym
Positive psychological intervention for PICS prevention
Region
| Japan |
Condition
Condition
Ischemic or valvular heart diseases.
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to determine, by the use of Arimitsu' s Japanese version of the Self-Compassion Scale, whether PPI (Positive Psychological Intervention)is effective for the prevention of PICS (Post Intensive Care Syndrom))of the cardiovascular surgery disease patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Optimism scale,Self-compassion scale,PTSD scale (Impact of Event Scale-Revised (Japanese version),Subjective well-being scale,Beck-Depression Inventory-2(Japanese edition)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The patients conduct a 'meditation' for three months.
Interventions/Control_2
Stop the meditation.
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
| 40 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients at the ages between 40 and 74 yr-old, who will undergo the thoracotomy operation.
2. Patients who will be transferred to ICU after the surgical operation of coronary artery (coronary artery bypass grafting) or the heart valve (valve replacement and valvuloplasty).
Key exclusion criteria
1. Patients with impaired cognitive function.
2. Patients who need immediate operation
3. Patients who will not be transferred to the ICU.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Ikeda |
Organization
Wakayama Medical University
Division name
Health and Nursing Sience
Zip code
Address
580 Mikazura Wakayama-shi Wakayama, 641-0011, Japan
TEL
073-446-6700
keiko-i-nc@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Ikeda |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
Address
580 Mikazura Wakayama-shi Wakayama, 641-0011, Japan
TEL
0734466700
Homepage URL
keiko-i-nc@wakayama-med.ac.jp
Sponsor or person
Institute
School of Health and Nursing Science Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
School of Health and Nursing Science Wakayama Medical University
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
Address
Tel
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
| 2022 | Year | 06 | Month | 10 | 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
| 2018 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 20 | Day |
Last modified on
| 2018 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036399
