UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061788 |
|---|---|
| Receipt number | R000070698 |
| Scientific Title | A Study on the Effects of Auditory Neurofeedback on Reducing Premenstrual Psychological and Physical Burdens |
| Date of disclosure of the study information | 2026/06/04 |
| Last modified on | 2026/06/03 17:06:13 |
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Basic information
Public title
A Study on the Effects of Auditory Neurofeedback on Premenstrual Symptoms
Acronym
Effects of Auditory Neurofeedback on Premenstrual Symptoms
Scientific Title
A Study on the Effects of Auditory Neurofeedback on Reducing Premenstrual Psychological and Physical Burdens
Scientific Title:Acronym
Effects of Auditory Neurofeedback on Reducing Premenstrual Psychological and Physical Burdens
Region
| Japan |
Condition
Condition
psychological and physical burdens in women before menstruation
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore whether auditory neurofeedback training (ANFT) can reduce psychological and physical burdens in women before menstruation, and how individual personality traits and interoceptive characteristics relate to the ANFT's effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in PMS-8 scores between baseline and final assessment
Key secondary outcomes
The following items will be explored investigatively:
- Changes in POMS2 scores before and after ANFT
- Changes in Electroencephalogram (EEG) and photoplethysmography (PPG) during ANFT
- Correlations among individual trait measures (MAIA, AASP, and TIPI-J scores) and changes in PMS-8 scores and PMDD rating scale scores
- Qualitative data regarding premenstrual symptoms and experiences with ANFT obtained through semi-structured interviews
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
[Intervention Group]
Auditory neurofeedback: Electroencephalogram (EEG) activity is analyzed in real time, and auditory stimuli are presented when alpha waves are dominant.
Three 10-minute sessions will be conducted per day, once a week, for a total of three weeks.
Interventions/Control_2
[Sham Control Group]
Random feedback: Auditory stimuli are presented, but the sounds are random and not linked to real-time EEG activity.
Three 10-minute sessions will be conducted per day, once a week, for a total of three weeks.
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
- Women residing in Kyoto Prefecture who are students enrolled in universities, vocational schools, or other educational institutions, as well as employed adults
- Women with normal hearing as confirmed by a hearing test using the Mimi Hearing Test on an iPad
- Women who are aware of experiencing discomfort before menstruation
- Women with a normal menstrual cycle (25-38 days)
Key exclusion criteria
- Women who are pregnant or breastfeeding
- Women with a history of, or currently receiving treatment for, the following conditions: gynecological organic diseases, psychiatric disorders, neurological disorders, respiratory diseases, or cardiovascular diseases
- Women with prior experience with auditory neurofeedback training (ANFT)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Inadomi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Advanced Occupational Therapy, Human Health Sciences
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3943
inadomi.hiroyuki.5e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Inadomi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Advanced Occupational Therapy, Human Health Sciences
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3943
Homepage URL
inadomi.hiroyuki.5e@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Hiroyuki Inadomi
Funding Source
Organization
Kyoto university
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Japan
Tel
075-366-7618
ethcom@kuhp.kyoto-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
京都大学大学院医学研究科人間健康科学系専攻(京都府)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 04 | 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
| 2026 | Year | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 06 | Month | 03 | Day |
Last modified on
| 2026 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070698
