Patient Preferences in Anesthesia for Abortion Care (PAC)

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Termination in First Trimester

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women undergoing first trimester surgical abortion choosing between oral anesthesia and nitrous oxide. All patients will be English-speaking women who are 18 years old or older.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Oral Sedation; Patients in this group will receive a standard procedure first trimester abortion using oral sedation for pain management following the clinic's protocol. Patients in both groups will be administered a Visual Analog Scale (VAS) assessing pain on an unmarked 100mm VAS scale with anchors at 0mm (left) being "no pain" and 100mm (right) being "pain as bad as it could be" before their procedure and immediately following procedure completion.
Nitrous Oxide; Patients in this group will receive a standard procedure first trimester abortion using titrated nitrous oxide for pain management following the clinic's protocol. Patients in both groups will be administered a Visual Analog Scale (VAS) assessing pain on an unmarked 100mm VAS scale with anchors at 0mm (left) being "no pain" and 100mm (right) being "pain as bad as it could be" before their procedure and immediately following procedure completion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Rameet Singh, MD, MPH, University of New Mexico Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Actual): February 23, 2022
• Study Completion (Actual): February 23, 2022

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimated): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pain management; Nitrous
• Other Study ID Numbers: 16-275

Plan for Individual participant data (IPD)

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