Unique ID issued by UMIN | UMIN000035629 |
---|---|
Receipt number | R000040588 |
Scientific Title | Mass production study of vaginal speculum to reduce pain |
Date of disclosure of the study information | 2019/04/01 |
Last modified on | 2019/01/23 00:14:50 |
Mass production study of vaginal speculum to reduce pain
Mass production study of vaginal speculum to reduce pain
Mass production study of vaginal speculum to reduce pain
Mass production study of vaginal speculum to reduce pain
Japan |
Cervical cancer, dysplasia of cervix uteri
Obstetrics and Gynecology |
Malignancy
NO
By using a new vaginal speculum in actual examination, confirm the physical safety and biological safety, and further compare the pain and discomfort felt by the patient with the conventional vaginal speculum.
Safety,Efficacy
Pain when inserting the vaginal speculum, cooling feeling
Physical safety and biological safety
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
2
Prevention
Device,equipment |
Using a prototype vaginal specimen once, quantify the pain and cooling sensation at the examination and compare both groups.
To evaluate pain, use a face scale classifying pain from 0 to 5, and cool feeling is done in 4 grades from 0 to 3 according to pain assessment.
Use a conventional vaginal specimen once, quantify the pain and cooling sensation at the examination, and compare both groups.
To evaluate pain, use a face scale classifying pain from 0 to 5, and cool feeling is done in 4 grades from 0 to 3 according to pain assessment.
20 | years-old | <= |
Not applicable |
Female
Person who is over 20 years old
Those who are judged to be able to do a diagnosis by a patient background such as past medical history
For this research, those who obtained consent by signing the consent form by the person himself / herself
Those who can answer the pain, discomfort, etc. of the diagnosis of the paratriceogram in the questionnaire
Study cooperation Person who did not obtain consent
Those who are supposed to have difficulty in diagnosis of gaggos such as sexual intercourse
Those who are judged not to be eligible for research participation by a doctor
200
1st name | |
Middle name | |
Last name | Naohiro Kanayama |
Hamamatsu University School of Medicine
Department of obstetrics and gynecology
Higashi-ku, Hamamatsu City Hayamayama 1 - chome 20-1
0534352309
ma-ni@hama-med.ac.jp
1st name | |
Middle name | |
Last name | Mari Mukai |
Hamamatsu University School of Medicine
Department of obstetrics and gynecology
Higashi-ku, Hamamatsu City Hayamayama 1 - chome 20-1
0534352309
ma-ni@hama-med.ac.jp
Hamamatsu University School of Medicine
Department of obstetrics and gynecology
Organization for Small & Medium Enterprises and Regional Innovation, JAPAN.
Government offices of other countries
NO
2019 | Year | 04 | Month | 01 | Day |
Unpublished
Preinitiation
2019 | Year | 03 | Month | 05 | Day |
2019 | Year | 03 | Month | 05 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 09 | Month | 30 | Day |
2020 | Year | 09 | Month | 30 | Day |
2020 | Year | 12 | Month | 31 | Day |
2019 | Year | 01 | Month | 23 | Day |
2019 | Year | 01 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040588