Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05645614 |
| Other study ID # |
APHP220368 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 9, 2022 |
| Est. completion date |
June 15, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Salignon Alexandra, MD |
| Phone |
142165762 |
| Email |
louise-laure.mariani[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of the study is to retrospectively analyze pain and anxiety assessment data
previously collected in routine care in women who had an abortion under local anesthesia in
order to identify the predictive factors of pain and anxiety, as well as to compare the
results with previously published data. The participants are women who underwent abortion
under local anesthesia in the gynecology department of the Pitié Salpêtrière Hospital between
May and October 2021.
Description:
Voluntary interruption of pregnancy corresponds to a social demand. The French National
Authority for Health recommends that any woman wishing to have a surgical abortion should
have the choice between general anesthesia and local anesthesia. The advantages of local
anesthesia are its simplicity and safety; the disadvantages are that the state of
consciousness during the procedure may be associated with anxiety, and the perception of
persistent pain despite the local anesthesia.
The majority of patients express pain during the procedure. Anxiety may be a major predictor
of pain during the procedure. Moreover, beyond its possible involvement in pain, anxiety is
also a factor of patient discomfort in its own right.
The 10-point verbal numerical scale was used for assessing pain and anxiety. The State Trait
Anxiety Inventory (STAI), a 20-item anxiety scale, is also used as a reference to measure
anxiety. This scale is carried out for patients undergoing an abortion under local anesthesia
in the department.
Other factors could have an impact on the level of pain : age, pregnancy term, parity,
history of dysmenorrhea, history of domestic violence or sexual violence.
The investigator team conduct a retrospective analysis in a cohort of patients who underwent
an abortion under local anaesthesia in the obstetrics gynecology department of La Pitié
Salpêtrière, analyzing their level of pain before, during and after the intervention The
secondary objective is to analyze their anxiety level. Age, term of pregnancy, parity,
history of dysmenorrhea, history of violence will be analyzed as potential predictive factors
of pain.
