Clinical trial NCT05645614: Anxiety and Pain During Intervention for Abortion Under Local Anesthesia
Official title: Retrospective Evaluation of Pain and Anxiety in Standard Routine Care During Abortion Under Local Anesthesia, in an Abortion Center
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abortion
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who had an abortion under local anesthesia

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* patients who need an abortion under local anesthesia
* Women who speak and read French

Exclusion Criteria:

* NA

Primary outcomes:
measure: Pain level of the patient before, during and after (10min post surgery) the abortion procedure under local anesthesia.
timeFrame: 3 hours
Secondary outcomes:
measure: Anxiety level of the patient before, during and after (10min post surgery) the abortion procedure under local anesthesia.
timeFrame: 3 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié Salpetrière
Study officials:
References: