UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054031 |
|---|---|
| Receipt number | R000061683 |
| Scientific Title | A Randomized Crossover Trial of the Psychophysiological Effects of Listening to Music Composed by Artificial Intelligence (AI) in Dialysis Patients |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/04/01 18:35:28 |
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Basic information
Public title
A Randomized Intervention Study of the Psychophysiological Effects of Listening to Music Composed by Artificial Intelligence (AI) in Dialysis Patients
Acronym
Psychophysiological Effects of Music Listening by Artificial Intelligence (AI) Composition
Scientific Title
A Randomized Crossover Trial of the Psychophysiological Effects of Listening to Music Composed by Artificial Intelligence (AI) in Dialysis Patients
Scientific Title:Acronym
Psychophysiological Effects of Music Listening by Artificial Intelligence (AI) Composition
Region
| Japan |
Condition
Condition
Psychophysiological Stress
Classification by specialty
| Nephrology | Psychosomatic Internal Medicine | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this randomized crossover study is to examine the effects of music therapy, consisting mainly of listening to music composed by artificial intelligence (AI), on psychological indicators such as subjective stress and depressive symptoms and physical indicators such as blood pressure, heart rate, autonomic nervous function and physical stress markers in patients undergoing regular dialysis treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic nervous system function (sympathetic and parasympathetic nervous system function) as assessed by heart rate and heart rate variability after 4 weeks of intervention
Key secondary outcomes
Blood test results (blood sugar, hemoglobin A1c, lipids and other items associated with stress)
Blood pressure, EEG, and oxidative stress (R-OOH) and antioxidant capacity (Fe reduction capacity)
Subjective stress, depression, happiness, frequency of laughter, lifestyle, subjective symptoms, and health-related quality of life (SF8) as assessed by questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
i) The subject will be fitted with an electroencephalograph to assess stress, and a series of stress assessments will be performed.
ii) A music therapy program installed on the tablet is performed. For the music therapy program, the subject selects several favorite songs from the prepared songs (past hit songs, etc.). The artificial intelligence (AI) automatically composes music based on the songs that are rated as relaxing by the subject's brain waves while listening to the music.
iii) Listen to the automatically composed music.
iv) Select and listen to the music of your choice. A total of 30-minute programs will be offered three times a week for four weeks.
Interventions/Control_2
Control group receiving usual care only
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) Men and women between the ages of 30 and 75 who are able to participate in the examination and intervention
(ii) Able to use the music therapy application on a tablet
(iii) Those who have received a thorough explanation of the study, fully understand it, and have given their free and voluntary written consent to participate in the study.
Key exclusion criteria
Those who have no history of serious mental illness in the past (but may participate if their symptoms are stable and they have a doctor's permission)
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ohira |
Organization
Fukushima Medical University School of Medicine
Division name
Department of Epidemiology
Zip code
960-1295
Address
Hikariga-oka 1, Fukushima-shi
TEL
024-547-1343
teoohira@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Ohira |
Organization
Fukushima Medical University school of Medicine
Division name
Department of Epidemiology
Zip code
960-1295
Address
Hikariga-oka 1, Fukushima-shi
TEL
024-547-1343
Homepage URL
teoohira@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
Fukushima Medical University Ethics Committee
Address
Hikariga-oka 1, Fukushima-shi
Tel
024-547-1825
rs@fmu.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 | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061683
