Tokyo, June 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061788) titled 'A Study on the Effects of Auditory Neurofeedback on Premenstrual Symptoms' on June 4.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Kyoto University

Condition: Condition - psychological and physical burdens in women before menstruation Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 24 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070698

Disclaimer: Curated by HT Syndication.