Mass-production research of the vagina mirror which reduces pain

JRCT ID: jRCT1040190052

Registered date:02/07/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: none
• Date of first enrollment: 02/07/2019
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Questionnaires of pain, discomfort and cold felt at the time of medical examination using a conventional product speculum and disposable speculum

Outcome(s)

• Primary Outcome: Using conventional vaginal speculum and disposable vaginoscope for the same patient, quantify and compare pain and cold at the time of examination
• Secondary Outcome: Examine physical safety and biological safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Person over 20 years old
2. A person who is judged to be able to see a hysteroscopic diagnosis by patient background such as medical history
3. For those who obtained consent by signing the consent form
4. Those who can answer pain and discomfort etc

Exclude criteria

1. Those who did not obtain research agreement
2. A person who is considered to have difficulty in acupuncture and moxibustion such as sexual intercourse
3. A person who is judged not to be eligible for the study by a doctor

Related Information

• Primary Sponsor: Ito Hiroaki