Pregnancy RelatedFACNCT04257318
Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study
A study testing Vibrating Relaxation Tool in people with Pregnancy Related, run by University Hospital, Rouen at 1 site in France.
Trial summary
Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Vibrating Relaxation Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 11 Aug 2020to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.
- Conditions
- Pregnancy Related
- Being tested
- Vibrating Relaxation Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating Relaxation ToolOther
Use of a Vibrating Relaxation Tool in case of pain during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Vibrating Relaxation Tool | Experimental | Use of a Vibrating Relaxation Tool in case of pain during pregn Receives: Other: Vibrating Relaxation Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Among patients who had the information visit, proportion of those who were included and applied the procedure at least twice
Measured: through study completion, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start11 Aug 2020
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric VERSPYCK, Pr, Principal investigator, University Hospital, RouenManon BESTAUX, Dr, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257318
- Sponsor's protocol ID
- 2018/0415/HP
- Acronym
- FAC
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2020
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bestaux-Brethez MM, Gillibert A, Sabatier T, Verspyck E. Potential analgesic function of the clitoris in pregnant women: A feasibility study. PLoS One. 2025 Dec 9;20(12):e0333112. doi: 10.1371/journal.pone.0333112. eCollection 2025.
PubMed 41364657
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clitoris Potential Analgesic Function Research by Pregnant Women : Feasibility Study
- ClinicalTrials.gov ID
- NCT04257318
- Acronym / sponsor ID
- FAC / 2018/0415/HP
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 6 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrating Relaxation Tool | Experimental | Other: Vibrating Relaxation ToolUse of a Vibrating Relaxation Tool in case of pain during pregn |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrating Relaxation ToolUse of a Vibrating Relaxation Tool in case of pain during pregnancy | Other | Vibrating Relaxation Tool |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Results publication: PubMed 41364657Bestaux-Brethez MM, Gillibert A, Sabatier T, Verspyck E. Potential analgesic function of the clitoris in pregnant women: A feasibility study. PLoS One. 2025 Dec 9;20(12):e0333112. doi: 10.1371/journal.pone.0333112. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric VERSPYCK, Pr principal investigator
University Hospital, Rouen
Manon BESTAUX, Dr principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating Relaxation Tool in people with Pregnancy Related, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: through study completion, an average of 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04257318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.