- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04257318
Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study (FAC)
January 16, 2024 updated by: University Hospital, Rouen
Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Manon BESTAUX
- Phone Number: 82 44 02 32 88
- Email: Manon.Bestaux@chu-rouen.fr
Study Locations
-
-
-
Rouen, France
- ROUEN university hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Pregnant woman, whatever the term, primiparous or multiparous
- Age ≥ 18 years old
- Patient having read and understood the information letter and signed the consent form
- Patient affiliated to Social Security
Exclusion Criteria:
- Inability to understand French or information,
- Person deprived of their liberty by an administrative or judicial decision
- Person placed under the protection of justice
- Person under guardianship or curatorship
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vibrating Relaxation Tool
Use of a Vibrating Relaxation Tool in case of pain during pregn
|
Use of a Vibrating Relaxation Tool in case of pain during pregnancy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability
Time Frame: through study completion, an average of 15 months
|
Among patients who had the information visit, proportion of those who were included and applied the procedure at least twice
|
through study completion, an average of 15 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric VERSPYCK, Pr, ROUEN university hospital
- Principal Investigator: Manon BESTAUX, Dr, ROUEN university hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 11, 2020
Primary Completion (Actual)
November 2, 2022
Study Completion (Actual)
November 2, 2022
Study Registration Dates
First Submitted
January 29, 2020
First Submitted That Met QC Criteria
February 4, 2020
First Posted (Actual)
February 6, 2020
Study Record Updates
Last Update Posted (Actual)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 16, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2018/0415/HP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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