UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029221 |
|---|---|
| Receipt number | R000033401 |
| Scientific Title | The effect of Yoshimoto Shin Kigeki (traditional comedy in Kansai, Japan) and old-fashioned Manzai (comic dialogue) on respiratory rehabilitation of patients with chronic respiratory failure : a prospective clinical study |
| Date of disclosure of the study information | 2017/09/20 |
| Last modified on | 2023/03/26 21:28:22 |
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Basic information
Public title
The effect of Yoshimoto Shin Kigeki (traditional comedy in Kansai, Japan) and old-fashioned Manzai (comic dialogue) on respiratory rehabilitation of patients with chronic respiratory failure : a prospective clinical study
Acronym
The effect of old-fashioned comedy for patients with chronic respiratory failure
Scientific Title
The effect of Yoshimoto Shin Kigeki (traditional comedy in Kansai, Japan) and old-fashioned Manzai (comic dialogue) on respiratory rehabilitation of patients with chronic respiratory failure : a prospective clinical study
Scientific Title:Acronym
The effect of old-fashioned comedy for patients with chronic respiratory failure
Region
| Japan |
Condition
Condition
Chronic respiratory failure
Classification by specialty
| Medicine in general | Pneumology | Geriatrics |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effect of laughter for mind and body, and efficacy of pulmonary rehabilitation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Questionnaire about respiration and depression(MRC, HAD, SRI, SF-8)
Blood examination
The activity of alpha-amylase in the saliva
Pulmonary function test
6 minutes walking test(if possible)
Rehabilitation-load
Key secondary outcomes
Age, sex, height, weight, BMI, blood pressure, pulse rate, respiratory rate, underlying disease, past history, smoking history, respiratory and cardiovascular symptom
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
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Watch the DVD of old-fashioned comedy three times a week for four weeks, in addition to usual rehabilitation program.
Interventions/Control_2
Only usual rehabilitation program.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with chronic respiratory failure. Underling disease do not matter (COPD, Interstitial pneumoniae, Nontuberculous mycobacteriosis, Bronchiectasis, etc.)
Previous treatment do not matter.
There is no limitation with laboratory data.
Key exclusion criteria
Clinically Unstable
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Sumi |
Organization
National Hospital Organization Minami-Kyoto Hospital
Division name
Department of Respiratory Medicine
Zip code
6100113
Address
Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL
0774-52-0065
kensukesumi@gmail.com
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Sumi |
Organization
National Hospital Organization Minami-Kyoto Hospital
Division name
Department of Respiratory Medicine
Zip code
6100113
Address
Naka Ashihara 11, Joyo city, Kyoto, Japan
TEL
0774-52-0065
Homepage URL
kensukesumi@gmail.com
Sponsor or person
Institute
Department of Respiratory Medicine, National Hospital Organization Minami-Kyoto Hospital
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
Department of Respiratory Medicine,National Hospital Organization Minami-Kyoto Hospital
Address
Department of Respiratory Medicine,National Hospital Organization Minami-Kyoto Hospital
Tel
0774-52-0065
kensukesumi@gmail.com
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
| 2017 | Year | 09 | Month | 20 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000033401
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
30
Results
Quality of life was improved by viewing comedy during the rehabilitation period.
Physical QOL remained effective after viewing ended, but mental QOL dropped after viewing ended.
Results date posted
| 2023 | Year | 03 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
30 patients underwent respiratory rehabilitation in our hospitalization.
15 watched comedy, 15 did not.
Participant flow
The 15 patients will watch comedy DVDs three times a week for four weeks in addition to their regular rehabilitation. The 15 patients underwent only regular rehabilitation.
Adverse events
none
Outcome measures
Questionnaire about respiration and depression(MRC, HAD, SRI, SF-8)
Blood examination
The activity of alpha-amylase in the saliva
Pulmonary function test
6 minutes walking test(if possible)
Rehabilitation-load
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033401
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