Patient Preferences in Anesthesia for Abortion Care

NCT ID: NCT03030443

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-04

Study Completion Date

2022-02-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Termination in First Trimester

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Rameet Singh

Chief, Division of Family Planning

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rameet Singh, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Health Sciences Center

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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16-275

Identifier Type: -

Identifier Source: org_study_id

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