UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies on the effect of a positive psychological intervention for the prevention of PICS
Title of the study (Brief title)	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	Keiko Ikeda
Organization	Wakayama Medical University
Division name	Health and Nursing Sience
Address	580 Mikazura Wakayama-shi Wakayama, 641-0011, Japan
TEL	073-446-6700
Email	keiko-i-nc@wakayama-med.ac.jp

Public contact
Name of contact person	Keiko Ikeda
Organization	Wakayama Medical University
Division name	School of Health and Nursing Science
Address	580 Mikazura Wakayama-shi Wakayama, 641-0011, Japan
TEL	0734466700
Homepage URL
Email	keiko-i-nc@wakayama-med.ac.jp

Sponsor
Institute	School of Health and Nursing Science Wakayama Medical University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036399