Patient Preferences in Anesthesia for Abortion Care

NCT03030443 | Completed

• 1 other identifier: 16-275
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy Termination in First Trimester

Keywords

Pain management; Nitrous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare quantitative and qualitative assessment of pain

  through patient completion in study, up to one week following the procedure

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of New Mexico: lead
• Society of Family Planning: collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rameet Singh, MD, MPH

  University of New Mexico Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Family Planning

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 25, 2017
• Study Start: April 4, 2017
• Primary Completion: February 23, 2022
• Study Completion: February 23, 2022
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)