UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038917 |
|---|---|
| Receipt number | R000044372 |
| Scientific Title | Effects of a self assessment checklist for premenstrual syndrome |
| Date of disclosure of the study information | 2019/12/25 |
| Last modified on | 2024/06/20 10:22:08 |
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Basic information
Public title
Effects of a self assessment checklist for premenstrual syndrome
Acronym
Effects of a self assessment checklist for PMS
Scientific Title
Effects of a self assessment checklist for premenstrual syndrome
Scientific Title:Acronym
Effects of a self assessment checklist for PMS
Region
| Japan |
Condition
Condition
Premenstrual syndrome
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of letting women know about premenstrual syndrome (i.e., the rate of ob/gyn visits) and to know the difference of the improvement of the symptoms or the productivity between those who visited doctors and those who did not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL scores on the SF-36
Key secondary outcomes
WHO-HPQ
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Use of the PMS self-assessment sheet
Interventions/Control_2
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
| 25 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Female
Key inclusion criteria
Women having paid job
Key exclusion criteria
Women receiving treatments at ob/gyn clinics
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | ERI |
| Middle name | |
| Last name | MAEDA |
Organization
Akita University
Division name
Environmental Health Science and Public Health
Zip code
0108543
Address
Hondo1-1-1, Akita
TEL
018-884-6087
erimaeda@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Eri |
| Middle name | |
| Last name | Maeda |
Organization
Akita University
Division name
Environmental Health Science and Public Health
Zip code
0108543
Address
Hondo1-1-1, Akita
TEL
018-884-6087
Homepage URL
erimaeda@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Welfare, and Labour
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita University
Address
Hondo 1-1-1, Akita
Tel
018-884-6087
erimaeda@med.akita-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
https://bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03067-2
Publication of results
Published
Result
URL related to results and publications
https://bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03067-2
Number of participants that the trial has enrolled
3090
Results
During the follow-up period, 4.9% of the participants sought medical help. Those with a high annual income and moderate-to-severe PMS were more likely to have sought medical help. Participants with moderate-to-severe PMS who had sought medical help showed a significant improvement of -8.44 points in intermenstrual MDQ scores and a significant improvement of 4.21 points in the Role/Social component summary scores during the follow-up period.
Results date posted
| 2024 | Year | 06 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In January 2020, women aged between 25 and 44 years, having paid work, and not currently consulting with an obstetrics and gynecology doctor (n = 3090) responded to the SF-36, the Menstrual Distress Questionnaire (MDQ), the Premenstrual Symptoms screening tool, and the World Health Organisation Health and Work Performance Questionnaire. In addition, they received checklist-based online education for PMS. Of 3090 participants, 2487 (80.5%) participated in a follow-up survey in September 2020.
Participant flow
An online market research company with a nationwide social research panel of more than 1 million registrants sent pre-screening emails to 184,022 randomly selected female registrants aged 25-44, and then accepted pre-screening responses until 20,000 respondents were reached. Of the 20,000 respondents, 7,752 women reported in the pre-screening survey that they were in paid employment and did not have regular access to an obstetrician and gynaecologist. Of the eligible registrants, 5,270 were randomly selected to receive recruitment emails. Finally, 3,090 completed the T1 survey on 6-7 January 2020 (58.6% participation rate among eligible subjects). All T1 participants were invited to complete the T2 survey, and 2,487 (80.5% follow-up rate) participated between 7 and 23 September 2020. The T2 survey was originally planned for July 2020, but we postponed the T2 survey by two months due to the start of the second wave of the COVID-19 pandemic in Japan.
Adverse events
None
Outcome measures
SF-36, Menstrual Distress Questionnaire (MDQ), and work productivity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 18 | Day |
Last modified on
| 2024 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044372
