UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057309 |
|---|---|
| Receipt number | R000063304 |
| Scientific Title | The effects of education about cervical mucus and promotion of self-monitoring on knowledge, awareness, and self-care behaviors among female university students : Single-group pre-post comparative study |
| Date of disclosure of the study information | 2025/03/17 |
| Last modified on | 2026/03/26 12:22:23 |
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Basic information
Public title
The effects of education about cervical mucus and promotion of self-monitoring on knowledge, awareness, and self-care behaviors among female university students : Single-group pre-post comparative study
Acronym
The effects of education about cervical mucus and promotion of self-monitoring on knowledge, awareness, and self-care behaviors among female university students : Single-group pre-post comparative study
Scientific Title
The effects of education about cervical mucus and promotion of self-monitoring on knowledge, awareness, and self-care behaviors among female university students : Single-group pre-post comparative study
Scientific Title:Acronym
The effects of education about cervical mucus and promotion of self-monitoring on knowledge, awareness, and self-care behaviors among female university students : Single-group pre-post comparative study
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of educating female university students about cervical mucus and encouraging them to observe it on their knowledge, awareness, and self-care behavior regarding cervical mucus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
knowledge, awareness, and self-care behavior regarding cervical mucus
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The research involved female university students receiving a lecture on cervical mucus and encouraging self-observation of cervical mucus, and then conducting a questionnaire survey before and after the intervention. The lecture was given once, lasting approximately 15-20 minutes.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Female university students who agree with the purpose of this research
Key exclusion criteria
None
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Chiba |
Organization
The University of Shiga Prefecture
Division name
Graduate School of Nursing
Zip code
522-8533
Address
2500 Hassakacho, Hikone City, Shiga Prefecture
TEL
0749-28-8665
chiba.y@nurse.usp.ac.jp
Public contact
Name of contact person
| 1st name | Mana |
| Middle name | |
| Last name | Yamamoto |
Organization
The University of Shiga Prefecture
Division name
Graduate School of Nursing
Zip code
522-8533
Address
2500 Hassakacho, Hikone City, Shiga Prefecture
TEL
0749-28-8665
Homepage URL
on41myamamoto@ec.usp.ac.jp
Sponsor or person
Institute
The University of Shiga Prefecture
Institute
Department
Personal name
Funding Source
Organization
The University of Shiga Prefecture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee on Ethical Review of Research involving Human, Subjects, The University of Shiga Prefecture
Address
2500 Hassakacho, Hikone City, Shiga Prefecture
Tel
0749-28-8612
kenkyu_shien@office.usp.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
| 2025 | Year | 03 | Month | 17 | 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
72
Results
Regarding the knowledge about vaginal discharge and cervical mucus, the proportion of participants who answered correctly on all six items increased significantly before and after taking the class (p<0.05). Awareness of vaginal discharge improved positively both after taking the class and 40 days later, with both positive and negative images improving. After 40 days, all participants were observing their vaginal discharge and the number of participants engaging in appropriate self-care behavior increased.
Results date posted
| 2025 | Year | 03 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age was 20.2, and the amount of the Faculty from nursing was the largest. 42 out of 70 participants (60.0%) had a normal menstrual cycle, and 69 out of 70 participants (98.6%) had received menstrual education, and 18 out of 70 participants (25.7%) had received leucorrhea education.
Participant flow
A total of 72 people participated in the 19 lectures, of which 2 pregnant women and those who did not consent to the study were excluded. The number of participants in each survey was 70 before the course, 69 (98.6%) after the course, and 34 (48.6%) 40 days later.
Adverse events
Outcome measures
When comparing before and after taking the course, the proportion of people who answered correctly increased significantly for all six items (p<0.05), but when comparing before and 40 days after taking the course, the proportion of people who answered correctly increased significantly for all items except for one item regarding the amount of cervical mucus (p=0.453).
There was some variation in responses to the pre-course survey, but after the course, responses to the two negative image items were concentrated in either "I don't think so at all," "I don't think so," or "Neither," and the results were roughly the same 40 days later. Positive images tended to become more positive, and negative images tended to improve to a more positive state.
The number of participants who observed their own vaginal discharge increased significantly from 12 participants (35.3%) before the course to 34 participants (100.0%) after 40 days. The number of participants who noticed changes in their vaginal discharge also increased significantly from 19 participants (55.9%) before the course to 30 participants (88.2%) after 40 days (p<0.05). The most common time to observe was "when the vaginal discharge became noticeable." Before the course, the majority of participants noticed changes in the "amount," but after 40 days, the number of participants who noticed changes in "color" and "transparency" also increased. In terms of self-care behavior, the number of participants who practiced incorrect methods such as washing the vulva with body soap or wiping from the anus toward the urethral opening after defecation decreased, while the number of participants who performed appropriate self-care behavior such as washing the vulva with only hot water and wiping the urethral opening with pressure after urination increased.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The title used during the ethics review was "A quasi-experimental comparative study on the effects of cervical mucus education and self-observation on female university students," which differs from the title used for registration.
Management information
Registered date
| 2025 | Year | 03 | Month | 17 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063304
