Anxiety and Pain During Intervention for Abortion Under Local Anesthesia (ADIAL)

Retrospective Evaluation of Pain and Anxiety in Standard Routine Care During Abortion Under Local Anesthesia, in an Abortion Center

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.

Study Overview

• Status: Recruiting
• Conditions: Abortion
• Intervention / Treatment: 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.

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.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Salignon Alexandra, MD; Phone Number: +33 142165762; Email: louise-laure.mariani@aphp.fr
• Study Contact Backup: Name: Mariani Louise Laure, MD,PH; Phone Number: +33 142165762; Email: louise-laure.mariani@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Hôpital Pitié Salpêtrière
    • Contact: MARIANI Louise Laure, MD; Phone Number: +33 142165762; Email: louise-laure.mariani@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

patients who had an abortion under local anesthesia

Description

Inclusion Criteria:

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

Exclusion Criteria:

• NA

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level of the patient before, during and after (10min post surgery) the abortion procedure under local anesthesia.	Evolution of pain over time (from preoperative to postoperative), self-assessed on a numerical scale from 0 to 10	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety level of the patient before, during and after (10min post surgery) the abortion procedure under local anesthesia.	Evolution of Anxiety over time (from preoperative to postoperative), self-assessed on a numerical scale from 0 to 10	3 hours

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Anticipated): June 15, 2023
• Study Completion (Anticipated): June 15, 2023

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: APHP220368

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No