NCT04257318

Brief Summary

Assessment of the acceptability by pregnant women on the research of the potential analgesic function of the clitoris.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 11, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
Last Updated

May 18, 2026

Status Verified

January 1, 2024

Enrollment Period

2.2 years

First QC Date

January 29, 2020

Last Update Submit

May 12, 2026

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

  • Acceptability

    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

Study Arms (1)

Vibrating Relaxation Tool

EXPERIMENTAL

Use of a Vibrating Relaxation Tool in case of pain during pregn

Other: Vibrating Relaxation Tool

Interventions

Vibrating Relaxation ToolOTHER

Use of a Vibrating Relaxation Tool in case of pain during pregnancy

Vibrating Relaxation Tool

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Related Publications (1)

  • 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.

    PMID: 41364657RESULT

Study Officials

  • Eric VERSPYCK, Pr

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

  • Manon BESTAUX, Dr

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

February 6, 2020

Study Start

August 11, 2020

Primary Completion

November 2, 2022

Study Completion

November 2, 2022

Last Updated

May 18, 2026

Record last verified: 2024-01

Locations

FR(1)