UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048422 |
|---|---|
| Receipt number | R000055143 |
| Scientific Title | Effectiveness of e-mail advice and self-symptom recording for women with perceived premenstrual syndrome (PMS) |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2023/01/26 09:12:43 |
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Basic information
Public title
Effectiveness of e-mail advice and self-symptom recording for women with perceived premenstrual syndrome (PMS)
Acronym
Effectiveness of symptom-recording app for women with PMS
Scientific Title
Effectiveness of e-mail advice and self-symptom recording for women with perceived premenstrual syndrome (PMS)
Scientific Title:Acronym
Effectiveness of symptom-recording app for women with PMS: a randamized, placebo-controlled trial
Region
| Japan |
Condition
Condition
Premenstrual syndrome (PMS)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of e-mail advice and symptom-recording app for reducing the burden of PMS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PMS-Impact (Impediments to life and social impact of PMS)
Evaluation period: 3 months after the start of app use
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
Symptom-recording using a smartphone app and self-care advice e-mails for 3 months
Interventions/Control_2
Observation
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
-Has regular menstruation
-Possesses a smartphone or tablet
-Is able to check daily e-mail in Japanese
-Is experiencing of PM
Key exclusion criteria
-Pregnant or lactating
-Has changed prescriptions for antipsychotics or female hormones, including OCs, in the last 3 months
-Has suicidal thoughts
-Is experiencing severe psychiatric or psycho-somatic disorder (e.g. bipolar disorder, severe depression, eating disorder)
-Is experiencing gynecological disorders (e.g. endometriosis, polycystic ovary syndrome)
-Never received psychotherapy for PMS
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Egawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-751-3269
megawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumie |
| Middle name | |
| Last name | Ikeda |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, JAPAN
TEL
075-751-3269
Homepage URL
yumieikeda@gmail.com
Sponsor or person
Institute
Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Transformative Research Areas
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 26 | 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
419
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Date of revised protocol fixation 2022/9/12
Date of IRB for revised protocol 2022/9/28
Date of permission 2022/10/5
Management information
Registered date
| 2022 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055143
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| Registered date | File name |
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| Registered date | File name |
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