Patient Preferences in Anesthesia for Abortion Care

Pregnancy Termination in First Trimester Clinical Trial

— PAC  

Official title:

Patient Preferences in Anesthesia for Abortion Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030443
• Other study ID #: 16-275
• Status: Completed
• Start date: April 4, 2017
• Est. completion date: February 23, 2022

Study information

• Verified date: May 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will use semi-structured interviews with participants in a prospective cohort study to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion to create a more patient centered experience. We will analyze two study cohorts of women undergoing first trimester surgical abortion: women choosing oral anesthesia and women choosing nitrous oxide.

Description:

This study will utilize an open-ended semi-structured interview format to elicit a broader understanding of the multi-dimensional pain experience of woman undergoing an abortion procedure. This study seeks to provide further evaluation of the pain experience and preferences of women receiving alternative methods of pain management such as oral sedation and nitrous oxide. The study will use semi-structured interviews to explore women's experiences of pain and preferences in pain management during first trimester surgical abortion and will include a procedural pain outcome using the visual analog scale (VAS) to create a more patient centered experience.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women undergoing first trimester surgical abortion choosing between oral anesthesia or nitrous oxide for pain management
• women who are able to read and understand English
• women who are 18 years old or older

Exclusion Criteria:

• under the age of 18
• women unable to consent and/or are cognitively impaired
• women who are incarcerated
• women who do not speak English

Related Conditions & MeSH terms

• Pregnancy Termination in First Trimester

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify Patient Priorities and Preferences for pain and pain management through Qualitative Analysis	To identify patient priorities and preferences for pain and pain management using Qualitative Analysis prior to their first trimester surgical abortion under local anesthesia with oral or nitrous oxide sedation.	through patient completion in study, up to one week following the procedure
Secondary	Compare quantitative and qualitative assessment of pain	Compare the quantitative objective assessment of maximum procedural pain using the visual analog scale (VAS) with the qualitative assessment of pain obtained via semi-structured interviews.	through patient completion in study, up to one week following the procedure