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Completed

NCT Number: NCT03227614

Friends/Family in the Abortion Procedure Room (FAIR)

This study aims to explore patient, support person, and health care providers' experience and satisfaction with social support in the abortion procedure room. Although some providers do allow a support person in the abortion procedure room, no study has formally examined the effects of this practice.

If this study demonstrates higher patient satisfaction and lower perceptions of pain and anxiety levels in patients who have social support in the in-clinic abortion procedure room, this could change standard procedures in the in-clinic abortion procedure room, allowing for more positive patient experiences.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parentehood of Southwest and Central Florida (PPSWCF)

Tampa, Florida, 33617, United States

About this study

Having an abortion is a complexly emotional experience for many women. Women with strong social support, from a partner, friend or family member, report better psychological adjustment. During medication abortion, patients reported high satisfaction levels, in part, because of being able to share the experience with another person. During in-clinic abortion, patients report lower levels of anxiety when they have a support person (partner, spouse, friend or family member) in the post-abortion recovery room. Additionally, support persons indicate feeling they can successfully comfort the woman. In the abortion procedure room, doula support has a positive psychological impact on patients and decreases the need for additional clinic support resources. Because doula support in the abortion procedure room and social support in the post-abortion recovery room improves patient experience, it is reasonable to believe that having a support person in the procedure room may also improve patient experience. However, there are no data about the patient, support person, and health care provider's experience and satisfaction with a support person in the abortion procedure room.

This study aims to explore patient, support person, and health care providers' experience and satisfaction with social support in the abortion procedure room. Although some providers do allow a support person in the abortion procedure room, no study has formally examined the effects of this practice.

If this study demonstrates higher patient satisfaction and lower perceptions of pain and anxiety levels in patients who have social support in the in-clinic abortion procedure room, this could change standard procedures in the in-clinic abortion procedure room, allowing for more positive patient experiences.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients:

  • Any patient who presents and consents for dilation and curettage
  • Patient participants 17 and younger must have a legal guardian provide consent for participation, and the patient must provide assent
  • Ability to provide written informed consent in English and comply with all study procedures

Support Persons:

  • Any person 18 years and older who the patient selects to accompany as their support person
  • Ability to provide written informed consent in English and comply with all study procedures

Health Care Providers:

  • Any health center staff attending to the enrolled patient in both intervention and control arms of the study
  • Ability to provide written informed consent in English and comply with all study procedures

Exclusion criteria

  • Patients without a support person on-site willing to participate
  • Patients or support persons that are unable to provide written informed consent in English and comply with all study procedures.

Treatment and study plan

Support Person Intervention

Behavioral

The patient participant will have a support person of her choice accompany her during her abortion procedure.

Primary outcomes

  1. Anxiety

    Time frame: 1 day

    Evaluating anxiety through State Trait Anxiety Inventory (STAI)

Secondary outcomes

  1. Perceived Pain

    Time frame: 1 day

    Patient Subject will take VAS Pain Scale to evaluate perceived pain

Sponsors and collaborators

Lead sponsor

Planned Parenthood of Southwest and Central Florida

Other

Registry information

Official study title

Friends/Family in the Abortion Procedure Room (FAIR): Assessing Pain Level, Patient, Staff and Support Person Satisfaction With Support Person in Abortion Procedure Room: A Randomized Controlled Trial

Acronym: FAIR

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2017
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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