ADIAL: Anxiety and Pain During Intervention for Abortion Under Local Anesthesia

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05645614
Collaborator
(none)
40
1
6
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: EVALUATION OF PAIN

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.

We 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Evaluation of Pain and Anxiety in Standard Routine Care During Abortion Under Local Anesthesia, in an Abortion Center
Anticipated Study Start Date :
Dec 15, 2022
Anticipated Primary Completion Date :
Jun 15, 2023
Anticipated Study Completion Date :
Jun 15, 2023

Outcome Measures

Primary Outcome Measures

  1. Pain level of the patient before, during and after (10min post surgery) the abortion procedure under local anesthesia. [3 hours]

    Evolution of pain over time (from preoperative to postoperative), self-assessed on a numerical scale from 0 to 10

Secondary Outcome Measures

  1. Anxiety level of the patient before, during and after (10min post surgery) the abortion procedure under local anesthesia. [3 hours]

    Evolution of Anxiety over time (from preoperative to postoperative), self-assessed on a numerical scale from 0 to 10

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patients who need an abortion under local anesthesia

  • Women who speak and read French

Exclusion Criteria:
  • NA

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Pitié Salpetrière Paris France 75013

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT05645614
Other Study ID Numbers:
  • APHP220368
First Posted:
Dec 9, 2022
Last Update Posted:
Dec 9, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 9, 2022