Tokyo, Jan. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060225) titled 'Development and Evaluation of Educational Program to Promote Health-related Behaviors among Women Aged 18-29 Years Experiencing Menstrual Pain that Disrupts Daily Life: a Pilot Randomized Controlled Trial' on Jan. 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Tokyo Metropolitan University
Condition:
Condition - Menstrual pain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aimed to evaluate the feasibility of conducting a randomized controlled trial to assess the effectiveness of an educational program for promoting health-related behaviors to menstrual pain among women aged 18-29 years who experience disruption in daily life owing to menstrual pain.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention group
Viewing e-learning materials and browsing materials according to their stage of behavior change.
Interventions/Control_2 - Control group
No materials will be provided until the end of the study; after completion, participants will be offered the opportunity to view the materials.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Female
Key inclusion criteria - Women experiencing disruption in daily life owing to menstrual pain
Key exclusion criteria - ･History of gynecological visits for menstrual pain
･Ongoing gynecological care
･History of endometriosis, uterine fibroids, adenomyosis, ovarian cysts, and/or secondary dysmenorrhea
･Use of oral contraceptives
Target Size - 40
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 12 Month 27 Day
Date of IRB - 2025 Year 09 Month 18 Day
Anticipated trial start date - 2026 Year 02 Month 08 Day
Last follow-up date - 2026 Year 04 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068883
Disclaimer: Curated by HT Syndication.
